Musculoskeletal diseases

Objective: To assess which patient characteristics influence the assessments of urgency for surgery by orthopaedic surgeons and non-orthopaedic professionals.Design, setting and participants: Cross-sectional study of 80 patients requiring elective hip or knee replacement attending a public hospital orthopaedic outpatient clinic or orthopaedic surgeon’s private rooms. Patients were interviewed after being placed on the surgery waiting list. The interview asked about the severity of their joint disease and its effects on physical capability, psychological distress and social circumstances. Patient interviews were summarised and presented to assessors who ranked groups of eight patients in order of their perceived urgency for surgery. Eleven orthopaedic surgeon assessors completed 360 patient ratings and nine non-orthopaedic assessors from various professions, including physiotherapy, social work, research, management and engineering, completed 720 patient ratings.Main outcome measures: Visual analogue scale rating of patient urgency for surgery; patient rankings for surgery; scores for individual domain contributions to urgency rating.Results: A broad spread of perceived urgency was evident among the patients. For each group of eight patients, there was moderate agreement on overall urgency rankings between the two groups of assessors. Linear regression demonstrated that pain was the dominant determinant of urgency score for both assessor groups. Orthopaedic surgeons also took into account limitations to mobility and concurrent medical illness but gave less priority to psychological distress or social circumstances. For the non-orthopaedic assessors, limitations to mobility, social circumstances and psychological distress also contributed to urgency.Conclusion: Both orthopaedic surgeons and non-orthopaedic professionals considered pain the most important factor in establishing urgency and priority for joint replacement. Only the non-orthopaedic professionals considered psychosocial factors important when determining priority for surgery. Broader community discussion about prioritisation for elective surgery is needed to facilitate agreement about which patients factors should be considered.

Andrea J Curtis BSc(Hons), PhD · Rory Wolfe BSc, PhD · Colin O H Russell MB ChB, FRACS · Barry G Elliott MB BS, FRACS, FAOrthA · John A L Hart FRACS, FAOrthA, FASMF · John J McNeil PhD, FRACP, FAFPHM

Back pain is very common; it has a point prevalence of 25% and is the third most common reason for consultation in Australian general practice. A thorough history and examination can identify the minority of patients who require urgent neuroimaging or other targeted investigations. Careful correlation of clinical and radiological findings is required when abnormal neurological findings are detected. Radiological investigations may detect abnormalities at multiple levels but cannot confirm which level is primarily responsible for a patient’s symptoms. A trial of conservative treatment is appropriate, even in cases of radiculopathy. Most patients with an acute episode of back pain recover within 6–12 weeks, but at least a third go on to have a recurrent episode within 1 year. Various invasive treatments, such as transforaminal steroid injection and discectomy, may speed up recovery from radiculopathy, but the long-term benefits of invasive treatment are uncertain.

Timothy J Kleinig MB BS(Hons), FRACP, PhD · Brian P Brophy MB BS, FRACS · Chris G Maher BAppSc(Phty), PhD

Carpal tunnel syndrome, resulting from median nerve compression at the wrist, is a common and often disabling mononeuropathy. Risk factors include female sex, family history, repetitive hand use, obesity, pregnancy and a variety of medical comorbidities including diabetes mellitus, rheumatoid arthritis, and other connective tissue diseases. In many cases, an accurate diagnosis can be reached on the basis of clinical history and supportive examination findings alone. Neurophysiological investigations are essential for confirming the diagnosis, assessing severity and excluding more generalised neuropathies, as well as providing a baseline preoperative index of median nerve function. Wrist splinting and local corticosteroid injection are effective treatments in the short term, but long-term data are lacking. Surgical (endoscopic or open) carpal tunnel release is effective and nearly always required to enable a return to work for patients with occupationally induced carpal tunnel syndrome.

Marion A Simpson MB ChB(Hons), MRCP(UK) · Bruce Day MB BS, FRACP

To the Editor: Although Indigenous males are twice as likely and Indigenous females are half as likely to report being diagnosed with osteoporosis compared with their non-Indigenous counterparts,1 data on the interracial differences in osteoporotic risk factors are limited. Our study of 276 patients attending a tertiary hip fracture unit in Western Australia over a 5-year period is the first to report differences in common risk factors for hip fracture between Indigenous and non-Indigenous patients. Our data showed a lower likelihood of vitamin D deficiency and polypharmacy but higher likelihood of diabetes mellitus, renal disease and alcohol use among Indigenous patients with hip fracture compared with non-Indigenous patients. Using the local orthogeriatric database, we identified 46 Indigenous and 230 randomly selected non-Indigenous patients aged ≥ 45 years who were transferred to a hip fracture unit following surgery for a minimal-trauma fracture at Royal Perth Hospital from July 2005 to June 2010. High alcohol use was defined as alcohol intake exceeding guideline recommendations,2 and polypharmacy as the use of more than five medications. We used a laboratory cut-off of 25-hydroxyvitamin D (25-OHD) < 50 nmol/L to indicate a low vitamin D level. Indigenous status was self-reported during admission. We compared data for Indigenous and non-Indigenous patients using the Mann–Whitney U and Pearson χ2 tests. We used logistic regression (SPSS version 17; SPSS Inc, Chicago, Ill, USA) to examine the association between Indigenous status and the predictor variables. Our study was exempted as a quality assurance activity from formal ethics review by the Royal Perth Hospital Ethics Review Committee and the Western Australian Aboriginal Health Information and Ethics Committee. Risk factors among the two groups are shown in the Box. The most common risk factors among Indigenous patients were antihypertensive use, high alcohol use and diabetes. In the final multivariate model, Indigenous patients with hip fracture were significantly more likely to have diabetes and renal disease and to report high alcohol use, but significantly less likely to have a low vitamin D level and polypharmacy, after adjustment for age, sex and rural residency. These well described risk factors contribute to fracture risk through two mechanisms: falls and secondary osteoporosis. Diabetes-related complications such as visual impairment, stroke and peripheral neuropathy can increase fracture risk.3 In renal dysfunction, osteoporosis is related to cortical thinning and uraemic osteodystrophy.4 Excessive alcohol intake at a young age among Indigenous people may affect peak bone mass.5 The effect of alcohol on liver cirrhosis, cognition, falls due to intoxication and peripheral neuropathy may contribute to fracture risk. Risk stratification will be more robust if these results can be cross-validated in other institutions. Associations between hip fracture and risk factors in Indigenous patients compared with non-Indigenous patients at Royal Perth hospital, July 2005 – June 2010 Variable Indigenous (n = 46) Non-Indigenous (n = 230) P* Crude OR Adjusted† OR (95% CI) Continuous (mean [SD]) Age at hip fracture‡ (years) 81.4 (9.1) 82.3 (9.4) 0.58 0.99 1.03 (0.96–1.10) 25-OHD level (nmol/L) 59.9 (30.2) 40.9 (18.6) < 0.001 – – Categorical (no. [%]) Women 29 (63%) 161 (70%) 0.35 1.11 2.52 (0.51–12.31) Non-metropolitan 42 (93.3%) 38 (16.6%) < 0.001 70.37 70.32 (14.43–342.59) Low vitamin D level§ 15 (38.5%) 142 (69.6%) < 0.001 0.27 0.26 (0.07–0.91) Prior fracture 9 (19.6%) 52 (22.6%) 0.65 0.83 0.42 (0.09–1.90) High alcohol use¶ 19 (41.3%) 10 (4.3%) < 0.001 15.5 13.25 (1.89–92.92) Diabetes mellitus 21 (45.7%) 41 (17.8%) < 0.001 3.87 8.19 (2.02–33.18) Renal disease 16 (34.8%) 21 (9.1%) < 0.001 5.31 6.12 (1.29–29.05) Polypharmacy** 18 (39.1%) 137 (59.6%) 0.01 0.44 0.17 (0.04–0.72) Antihypertensive use 26 (56.5%) 118 (51.3%) 0.52 1.23 2.75 (0.70–10.76) 25-OHD = 25-hydroxyvitamin D. OR = odds ratio. * Mann-Whitney U or Pearson χ2 test. Level of significance: P < 0.05. † Multivariate logistic regression. ‡ Minimal-trauma fracture. § 25-OHD level < 50 nmol/L. ¶ Alcohol intake exceeding guideline recommendations.2 ** > 5 drugs.

Michelle M Y Lai · Nicholas G Waldron

Hard lessons for device manufacturers, regulators and surgeons in the wake of a market recall Hip replacement is one of the most cost-effective surgical procedures undertaken today. It relieves pain and restores mobility and independence for almost 35 000 individuals each year in Australia. However, recent publicity in Australia and overseas about the recall of hip prostheses from the market has created uncertainty and anxiety in patients who have undergone or are about to undergo hip replacement or other types of joint replacement surgery. Medical practitioners need to have a clear understanding of the issues and their implications so they can assist and advise patients appropriately. In December 2009, the ASR (articular surface replacement) hip system, manufactured by DePuy Orthopaedics (Warsaw, Ind, USA), a division of Johnson and Johnson, was withdrawn from the Australian market. The ASR system consisted of resurfacing (ASR Hip Resurfacing System) and conventional total hip replacement (ASR XL Acetabular Hip System) prostheses. The resurfacing prosthesis was introduced in Australia in 2003 and the conventional prosthesis in 2004. Both prostheses used a chromium–cobalt metal-on-metal articulation. The Australian Orthopaedic Association National Joint Replacement Registry (AOA NJRR) first published concerns about the outcome of the ASR resurfacing prosthesis in its 2006 annual report.1 In its 2007 report, it identified the ASR resurfacing prosthesis as an outlier,2 meaning that its revision rate was greater than twice the rate for all other resurfacing prostheses combined and that this difference was statistically significant. In 2008 and 2009, the Registry identified both the ASR resurfacing and conventional prostheses as outliers.3,4 DePuy voluntarily recalled both prostheses from the Australian market at the end of 2009. At that time, more than 5500 patients in Australia had received these devices (4410 conventional ASR and 1167 resurfacing ASR). After receiving further information from the National Joint Registry of England and Wales, DePuy undertook a worldwide recall of both prostheses in August 2010. It is estimated that 93 000 patients globally had received these devices.5 The most recent (unpublished) data from the AOA NJRR show that, at 6 years, the ASR conventional prosthesis has a 13.6% cumulative percentage revision rate (after 1.5 years: hazard ratio, 4.92 [95% CI, 4.25–5.70], P < 0.001) and the ASR resurfacing prosthesis has an 11.1% cumulative percentage revision rate (hazard ratio, 2.24 [95% CI, 1.81–2.77], P < 0.001). It is not currently possible to know how many patients with an ASR prosthesis will eventually require revision, but this number could potentially be high. It remains unclear why the ASR system has a high revision rate. It is known that these prostheses can wear at an accelerated rate, but the mechanisms causing this have yet to be established. Such wearing results in high local concentrations of both metal particles and metal ions, which cause an inflammatory response that can be quite marked and associated with significant bone and soft tissue damage.6 Revision surgery is usually required, but the outcome is often less than satisfactory. Very high serum levels of chromium and cobalt have also been detected in some patients,7 raising concerns about the potential for serious systemic toxic effects. In this issue of the Journal, Mao and colleagues report the first Australian patients with ASR prostheses to show a potential association between high serum metal ion levels and systemic toxicity.8 Their report also highlights the difficulties in understanding the relevance and significance of these high metal ion levels. To date, there have only been anecdotal case reports of potential toxicity,7 and this is another such publication. The authors have been clear in stating that it is not possible to draw conclusions because there is not enough evidence to determine if the problems these patients have experienced are coincidental rather than causal. What this and other reports have done, however, is highlight the urgent need to undertake comprehensive research to examine the relationship between high serum metal ion levels after total hip replacement and the risk of toxicity. It is critical to determine at what concentration elevated cobalt and chromium serum levels may cause toxicity, and how the extent and severity of toxicity varies with the level. This is important because surgeons currently have no information on whether a hip should be revised based simply on the patient’s serum metal ion levels. Revision surgery has significant morbidity and mortality risks and should not be undertaken without good indications to do so. The high revision rate of the ASR system raises the question of whether this is a prosthesis-specific problem or a wider issue with all metal-on-metal prostheses. The ASR system certainly has a higher rate of revision than other metal-on-metal prostheses, but there is increasing evidence that some metal-on-metal hip prostheses are not performing as well as those that use other articulations, particularly where larger femoral head sizes are used.4,9 The AOA has recently advised its members to use metal-on-metal prostheses with caution. There has been discussion within the orthopaedic and wider community regarding the role of surgeons in the design, development and subsequent use of new prostheses. Surgeon involvement can be a very good thing as it may ensure that not only the design, but also the approach to implanting the device, is optimised. However, it is clear that transparency and accountability are needed around any relationship a surgeon may have with a device manufacturer. In 2010, the AOA developed a code of conduct for its members, which incorporates a position statement on interaction with the medical industry.10 This clearly defines surgeons’ responsibilities when dealing with companies. The global experience with the ASR system, and potentially all metal-on-metal devices, has important ramifications for arthroplasty device regulation. How is it that the ASR was approved for use? Could this situation occur again? Currently, it is not mandatory in Australia for a new hip or knee prosthesis to have clinical evidence specific to the device that indicates it is either safe or effective. The regulatory requirements for medical devices are stratified according to perceived risk. This situation is not unique to Australia. Some years ago, the AOA recommended to the Therapeutic Goods Administration (TGA) that clinical evidence requirements for joint replacement prostheses should be increased. In particular, it requested that these devices be reclassified from Class 2B to Class 3. Class 3 requires greater scrutiny of clinical evidence before a device is approved. The TGA is currently considering the reclassification of these devices and it is hoped that the experience with the ASR system will ensure it happens soon, as this would significantly reduce the likelihood of another similar occurrence. The good news story out of all this is that Australia clearly has a very effective post-market surveillance system for joint replacement prostheses. The early identification by the AOA NJRR that the ASR system had a higher than anticipated rate of revision significantly reduced the local use of these prostheses and eventually resulted in Australia being the first country to have the ASR system recalled. The AOA NJRR has been supported by the Australian Government since its inception, and Commonwealth legislation passed in 2009 has ensured the ongoing funding of the Registry. The most recent data from the Registry indicate that 95% of people undergoing hip replacement still have a functioning joint 10 years after surgery. Despite the experience with the ASR system, the risk of revision is declining. These results will be further enhanced if device manufacturers, regulators and surgeons take heed of the lessons learned from the ASR system recall.

Stephen E Graves MB BS, DPhil, FAOrthA

We report two Australian patients with possible cobalt toxicity related to metal-on-metal total hip replacements. Both patients were treated for osteoarthritis with a DePuy ASR (articular surface replacement) XL Acetabular Hip System prosthesis, which contains cobalt and chromium, and which has recently been recalled from the market. (MJA 2011; 194: 649-651) Clinical recordsPatient 1A 73-year-old woman presented to our orthopaedic clinic in February 2011 for follow-up of a right total hip replacement that had been performed 5 years previously because of osteoarthritis. At review, she had neurological symptoms, including cognitive decline, memory difficulties and depression, which had been present for 7 months since a cerebrovascular episode. She also had a continuous metal taste in her mouth and complained of severe headaches, anorexia and weight loss. She had mild groin pain but otherwise no symptoms related to her hip. X-rays showed a well fixed, well aligned implant, with mild osteopaenia around the acetabular component. Her serum cobalt level was 410 nmol/L (reference range, 0–20 nmol/L) and chromium level was 240 nmol/L (reference range, 0–100 nmol/L). The cerebrovascular episode had occurred in July 2010, when the patient experienced symptoms consistent with a stroke: dizziness, disorientation, nausea, vomiting and being “off balance on the left side”. She had particularly noted difficulty in remembering names and registering information (both written and aural), headaches and cerebellar signs (ataxia and dysdiadochokinesis). She had been admitted to the stroke unit and treated with ongoing clopidogrel. A computed tomography (CT) scan at this time showed a hypodensity in the right anterior commissure, although it could not be confirmed whether this represented a lacunar infarct or a perivascular space. CT angiogram, echocardiogram and thyroid function test results were all normal and she had no previous history of depression or dementia. The patient’s original hip replacement had been done in 2006 with an ASR (articular surface replacement) hip prosthesis (ASR XL Acetabular Hip System [DePuy Orthopaedics, Warsaw, Ind, USA]), comprising a large-diameter metal (cobalt and chromium) cup with a large modular metal head on a titanium Corail stem (Box). A revision total hip replacement was performed in March 2011, principally because of her systemic symptoms and elevated cobalt and chromium levels. The ASR metal cup and head were removed and the stem retained. Her acetabulum was revised with an all-polyethylene cemented cup and the head was changed to a ceramic one. At the time of surgery, 30 mL of turbid fluid was aspirated from the joint and debridement of metal stained tissue was undertaken. The concentration of cobalt in the joint fluid was 4218 nmol/L and chromium was 217 000 nmol/L. Cerebrospinal fluid (CSF) collected at surgery showed a cobalt level of 9 nmol/L and a chromium level of 13 nmol/L (no reference ranges for these in CSF), showing that the ions had crossed the blood–brain barrier. At 8-week follow-up after the revision surgery, the patient felt much improved. She had regained a normal appetite and gained weight, the metallic taste in her mouth had gone, and she had less fatigue and greater energy. The hip pain had completely resolved and she was walking up to 2 km a day. Her serum cobalt level had reduced to 60 nmol/L. Patient 2A 60-year-old male professor of engineering presented in January 2011 with systemic symptoms, for follow-up after a right total hip replacement with a DePuy ASR XL Acetabular Hip System prosthesis 4 years previously. He had no hip symptoms, but an x-ray showed quite marked bone loss around the acetabular component. Before his hip replacement surgery, the patient had been working full time and enjoyed excellent general health, apart from pain and stiffness in his right hip secondary to osteoarthritis. Three years after the surgery, he developed symptoms that steadily increased in severity: painful muscle fatigue in all limbs associated with cramps in the hands and feet, particularly at night; dyspnoea and feeling faint when performing simple tasks; inability to climb a flight of stairs without needing to rest; and a decline in cognitive function (although this was not quantified). He particularly noted problems with remembering names and poor concentration. His previously stable hypertension had become uncontrolled and required additional medication. The patient’s serum cobalt level had been measured in September 2010 and found to be 185 nmol/L, and subsequently remained consistently elevated at between 213 nmol/L and 258 nmol/L. His chromium level was never elevated. In February 2011, the patient had a revision total hip replacement performed because of his systemic symptoms, in spite of having no hip symptoms. At revision surgery, the titanium stem was retained, and the metal head and cup were changed to ceramic and polyethylene versions, respectively. There was no metal debris or localised tissue reaction. Immediately before the revision surgery, the patient’s serum cobalt level was 258 nmol/L, with a normal level of chromium (88 nmol/L). At 8-week follow-up after the revision surgery, the patient reported significant improvement in his energy levels and a decrease in muscle pains. He had significantly improved exercise tolerance and was able to walk without restriction. His serum cobalt level had fallen to 42 nmol/L. DiscussionTotal hip replacement is generally a successful operation, with a long clinical history of good outcomes. Conventional total hip prostheses consist of a metal head that fits into a polyethylene cup. Concerns have been raised, particularly in younger patients, that the plastic cup suffers wear and tear with time and may require revision. In an attempt to decrease wear at the interface of the articulation, metal-on-metal bearings (Box), composed of cobalt and chromium, have gained widespread popularity and have been used extensively, particularly in the United States. However, some of these metal-on-metal prostheses have not lived up to the promise of increased durability. The Australian National Joint Replacement Registry (NJRR) notes large differences in the performance of different types of metal-on-metal hip prostheses. An acceptable upper rate of failure of hip prostheses is considered to be below 1% per year, with the vast majority of implants studied by the NJRR falling well below this failure rate.1 The ASR prosthesis originally implanted in both patients reported here has recently been withdrawn from the market, after about 100 000 were implanted worldwide. Its revision rate reported on the NJRR in 2010 was 6.4% at 3 years when inserted with a Corail stem and 10.9% at 5 years when inserted as a resurfacing.1 Updated guidance from the British Hip Society’s 2011 conference noted a higher than anticipated early failure rate [in large-diameter metal-on-metal hip replacements]. These range from [a] 21% revision rate at 4 years (potentially rising to 35% if all currently known painful implants progress to revision) to 49% at 6 years for the ASR XL device. Other devices have a revision or impending revision rate of 12 – 15% at 5 years.2 An additional problem with metal-on-metal bearings is that they release a variety of metal ions into local tissue and the general circulation, with chromium being the most widely reported of these. Increased cobalt levels have been reported to be associated with neurological3,4 (hand tremor, incoordination, cognitive decline, depression, vertigo, hearing loss and visual changes), cardiac (arrhythmias and cardiomyopathy) and endocrine5,6 symptoms. Symptoms of cobaltism have been previously described when cobalt was used to treat refractory anaemia in patients 40 years ago.7 The term “arthroprosthetic cobaltism” has been coined to describe these manifestations in patients with joint replacements.3 The direct effect of cobalt on cells has recently been explored. Exposure to cobalt ions was found to significantly inhibit osteoblast function by reducing alkaline phosphatase activity and calcium deposition, and to rapidly induce the secretion of proteins IL-8 and MCP-1 in primary human osteoblasts.8 This may have implications for bone ingrowth onto implants and osteolysis around the hip replacement. Other reported effects of elevated cobalt levels on cells include abnormal lymphocyte function,9,10 chemokine secretion11 and ischaemic changes in rat brains.12 A relationship between symptoms and peak cobalt levels, or the length of exposure to cobalt, has not been established. We believe our patients’ symptoms were related to their elevated cobalt levels, resulting from cobalt leaching out of their hip prostheses. Both patients had metal-on-metal hip prostheses, and both patients’ cobalt levels were reduced after removal of the metal-on-metal prosthesis. We are concerned that cobalt toxicity may be under-recognised, particularly if patients consult doctors who may not be aware of the details of the patient’s hip replacement and the potential for release of cobalt into the circulation. The British Hip Society recommends regular follow-up of patients with metal-on-metal hip replacements for at least 5 years and probably for the life of the prosthesis.2 Clinical manifestations of cobalt toxicity may occur many years after implantation of the prosthesis and appear to stay elevated over extended periods of time.13 Long-term exposure to cobalt may also be associated with cancer.14 Patients should therefore be followed up carefully, with specific questioning about alterations in neurological, cardiac, respiratory and endocrine function. In the presence of persistently elevated metal ion levels and symptoms consistent with metal toxicity, once other causes have been excluded, revision hip replacement is the only method available to decrease the ion levels. X-ray of Patient 1’s right metal-on-metal articulation hip replacement, with well fixed cementless femoral and acetabular implant

Xinzhan Mao MD · Andrew A Wong MB BS, PhD, FRACP · Ross W Crawford MB BS, DPhil(Oxon), FRACS(Orth)

I was first diagnosed with osteoarthritis in 1989, at the age of 19 years. I had been having problems with horse-riding (my all-consuming hobby was equestrian competition — eventing and showjumping), getting pain in both hips when riding larger horses and after long rides. In hindsight, I had been showing symptoms for years. From a young age I had trouble sitting cross-legged, and at age 16 had started getting some lower back pain, which I now believe was a consequence of developing flexion deformities. I was told that I would need hip replacements by the age of 40, but that I must try to postpone this evil day as long as possible because hip implants only lasted about 10 years. As my inflammatory markers were never raised, treatment was conservative (non-steroidal anti-inflammatory drugs, paracetamol, physiotherapy and exercise), and I was encouraged to continue my equestrian activities as a form of physical therapy. In 1996, I moved to Adelaide to commence a graduate medical course (my first degree was in molecular biology and immunology). My arthritis symptoms gradually interfered more and more in my daily life. By the time I graduated, I was experiencing continuous pain on weight-bearing on the right side, and by the end of 2003 I was unable to ride my beloved horses at all. In 2007, my symptoms accelerated until I was unable to stand on my right leg and had to walk with a stick. It was clear that it was time for more drastic intervention and, as predicted, I was approaching 40. In November, I selected an orthopaedic surgeon, based partly on the experience of a colleague’s husband, a marathon runner of similar age to me, who had recently undergone a new hip resurfacing procedure that had been developed for younger, more active patients. The surgeon told me that the new metal-on-metal hip resurfacing implant would give me back a normal range of movement and mobility and that it would last 30 years. He also said that he had helped design software that enabled computer-guided placement of the implant to within 1 degree of the patient’s original joint position. He organised for me to have bilateral corticosteroid injections in my hips, to help with pain management and so that I could exercise and develop some muscle strength before surgery. My husband (also a doctor) and I did a basic literature search and found some questions about metal ion deposition and systemic release. On raising these concerns with the surgeon, I was told that this was not a problem with these implants. The brand of device to be used was not discussed before my surgery; it was only later I learned that the devices implanted were both the ASR (articular surface replacement) Hip Resurfacing System (DePuy Orthopaedics, Warsaw, Ind, USA). I had the surgery in April 2008 — the right hip first, followed by a hospital stay of 5 days, then 2 nights at home before the left hip was replaced. I had a fairly prolonged recovery (I was only able to return to work, part-time, in late November) and thought this was due to having both hips replaced within a short time and also to the severity of my arthritis. The surgeon told me that, at operation, both hips looked to be the end result of untreated congenital hip dysplasia, which is a common cause of premature osteoarthritis. I attended physiotherapy every 2 weeks, working hard to stretch out my flexion contractures, and saw the surgeon for follow-up in May, July and October; examinations and x-rays all apparently looked as they should. I gradually improved and was pleased to have a return of a greater range of movement, although a minor fall in December 2008 led to acute right hip pain, which resolved after following advice from my surgeon to avoid weight-bearing for 6 weeks. I continued to improve throughout 2009, although the right hip was never fully pain-free on weight-bearing. In late 2009, I developed pain in my right hip that was worse when lying on my right side, and in February 2010 my rheumatologist diagnosed right trochanteric bursitis (confirmed by ultrasound). I contacted my surgeon, who advised against a cortisone injection. Instead I was given some exercises (“sit like a man”, “walk like Charlie Chaplin”) and instructions to “avoid stairs” and ice the affected bursa. The bursitis pain continued, and I began to develop groin pain in both hips, mainly on weight-bearing. The pain became worse and was affecting both my work and my home life. In the middle of 2010, I received a letter stating that my surgeon had retired, and that an appointment had been made for me in October with his replacement. Unsure what to do (and unsure if anything could be done anyway), I waited. It was almost a relief when I first heard the news in August 2010, via the New York Times website, about the ASR hip systems being recalled — perhaps this explained my symptoms. In October I saw the replacement surgeon, who noted a globally decreased range of movement in both hips, restricted by both stiffness and pain. My serum metal ion levels were not elevated (chromium, 38 nmol/L; cobalt, 19 nmol/L). Magnetic resonance imaging and ultrasound confirmed the right trochanteric bursitis and I had a cortisone injection, which relieved the bursitis pain but not any of my other pain. I was told that, at this point, revision surgery was not yet necessary. I have since sought a second opinion with an independent surgeon, and investigations are continuing. My pain has worsened on both sides, and my flexion contractures have returned, as well as further global restriction of my range of movement. After first hearing of the ASR implant recall, I had done some research and found that concerns had already been raised on the Australian Orthopaedic Association National Joint Replacement Registry (whose annual reports are freely available on the internet) about a higher than expected early failure rate — in 2006 for the ASR resurfacing system, and in 2008 for the conventional ASR. Through the media (the ABC television program Four corners in May 2011), I discovered that many other patients with the ASR hip replacement had had significant problems after their surgery. If I had not been a doctor, I wonder whether I might have gone into this with more scepticism. “Regular” patients frequently attend their consultations armed with notes from “Dr Google”, family or friends’ anecdotes, and warnings from their naturopaths. They do some kind of research, however ill guided it might be. As a doctor, however, I have always trusted my colleagues. How can I refer my own patients to a fellow doctor if I don’t trust him or her to do the right thing? I think I trust(ed) my colleagues much more than a non-doctor would. We have the shared experiences of medical school, internship and resident years, and I have seen the rigour expected in specialist training. I have always put my faith in specialists to do the right thing. The only exception has been when I have heard about doctors who prescribe a remedy (frequently a “non-allopathic” formulation), then sell the patient a bottle of it from their medicine cabinet. I have always believed that you shouldn’t prescribe what you also sell. Had I known more about this device, its development and its potential problems that were already known before I had my surgery, I would have asked many directed questions, done more research and perhaps sought another opinion. After all, nobody unknowingly volunteers to be part of a Phase IV clinical trial, do they?

Catherine S Gunson BSc(Hons), BM BS

Rock music may be bad for your knees as well as your ears Clinical record In May 2009, a 17-year-old woman in the dance floor audience at a rock concert was performing “air guitar” — a form of dance and movement in which a performer mimes to rock or heavy metal guitar music, commonly requiring enthusiastic jumping and leaping about a “stage”. While performing a manoeuvre involving a jump into the air, she landed awkwardly on her right leg. She noted immediate intense right knee pain with obvious patellar deformity. An ambulance was called, and a dislocation of the right patella was diagnosed. Under methoxyflurane inhalation, ambulance officers reduced the dislocation by manoeuvring the knee into full extension. On arrival at the emergency department, the patient complained of pain “everywhere” in the knee. There was no obvious swelling or deformity of the knee joint. There was tenderness over both the medial and lateral collateral ligaments, with minimal patellar tenderness. She had full painful range of movement. Radiological examination of the knee showed a joint effusion with lateral subluxation of the patella. There was a 2 mm ossicle lateral to the lateral femoral condyle, which may have represented an acute avulsion fragment. A compression bandage was applied, and the patient was discharged with analgesia and crutches, with follow-up to be undertaken with her general practitioner. The patient re-presented to the emergency department 36 hours later with a painful and swollen knee joint. After discussion of treatment options with the patient and her mother, a decision was made to proceed to arthroscopy. At arthroscopic debridement, a tense haemarthrosis was released. A bleeding point was identified at the patellar attachment of the torn medial patellofemoral ligament. A synovectomy of the affected area was performed, and haemostasis of the local bleeding vessel was achieved with diathermy (Box). There was minor chondral damage about the medial patellar facet. Other joint structures were intact and there was no fracture. The patient had an uncomplicated recovery with routine postoperative care. At 3-week review, she was able to walk comfortably unaided. There was minimal effusion and she had a full range of movement. She was prescribed a muscle-strengthening program and referred to a physiotherapist, and she made a full and uneventful recovery. DiscussionDislocation of the patella is an injury more commonly seen in young athletes and usually spontaneously reduces at the time of injury.1 There has been no report in the medical literature of a knee injury sustained during a musical performance. Although the literature describes several maladies attributed to guitar playing, such as wrist injury,2 overuse injury to the digits,3,4 and irritation of the skin secondary to exposure to the instrument’s surface,5-7 there are no reports of an acute physical injury due to guitar playing. There is a single internet report of an acute injury sustained while playing a guitar-like instrument — an avulsion injury of the lateral condyle of the left femur, incurred while playing the video game Guitar Hero.8 An internet search using Google found numerous reports of acute injuries attributed to the performance of air guitar. The Chicago Sun-Times reported an unspecified back injury to the reigning Chicago Region Air Guitar champion,9 while the winner of the United States Air Guitar regional competition in Brooklyn “rocked so hard during a daredevil performance that doctors had to amputate a toe she broke during the gig”.10 There are also reports of a knee injury as a result of jumping from a height during a performance and an ankle injury sustained after jumping from speakers.11 There has even been a report of death due to air guitar — a student in Singapore fell to his death from a building when he was “jumping up and down on the bed placed against an open window while mimicking a rock guitarist”.12 Our case suggests that injuries due to the performance of air guitar are a source of previously unrecognised and unreported morbidity and demonstrates that, even though the instruments used in air guitar are imaginary, the injuries sustained are quite real. Rock music may be bad for your knees as well as your ears. Arthroscopic photograph of the knee joint Diathermy-treated bleeding point within the medial patellofemoral retinaculum (arrow).

Robert J Douglas BA, BAppSc(Dist), BM BS · Jason Ward BM BS, FRACS(Orth)

Objectives: To establish the rate of clinically significant weight change after 12 months in patients who have had a primary total hip arthroplasty (THA); to identify patient characteristics that predicted weight loss or gain; and to compare clinical and functional outcomes between obese and non-obese patients.Design, setting and participants: Prospective study of 471 patients who underwent THA between 2006 and 2007 at St Vincent’s Hospital, Melbourne, a university-affiliated tertiary referral centre. Patients were classified as non-obese, obese and morbidly obese, and were assessed using the Harris Hip Score (HHS) and 12-item Short Form Health Survey (SF-12).Main outcome measures: Incidence of weight loss or gain 12 months after surgery; preoperative patient variables predictive of weight change; functional and quality-of-life outcomes and rate of adverse events at 12 months; differences in outcomes between obese and non-obese patients.Results: 194 patients (41%) were obese or morbidly obese. At 12-month follow-up, 18 obese or morbidly obese patients (9%) had lost ≥ 5% of their preoperative weight and 118 patients (25%) had gained ≥ 5% of their preoperative weight. No preoperative predictor of weight loss was identified, but weight gain was associated with lower preoperative SF-12 mental health scores (odds ratio [OR], 0.98 [95% CI, 0.96–0.99]; P = 0.04). There were no significant differences between obesity groups in improvement in HHS or SF-12 physical health scores. Improvement in SF-12 mental health scores was greater in obese (+ 3.6 [SD, 12.2]) and morbidly obese (+ 3.7 [SD, 9.4]) patients than in non-obese patients (– 0.1 [SD, 11.7]) (P = 0.01). Compared with non-obese patients, the odds of a postoperative complication were significantly greater in obese patients (OR, 1.81 [95% CI, 1.05–3.11]) and morbidly obese patients (OR, 5.77 [95% CI, 2.10-15.86]).Conclusion: Clinically significant weight loss in obese patients after THA is uncommon. Obese and morbidly obese patients experience comparable reduction in pain and improvement in function after THA, but the risk of complications in the first 12 months after surgery is significantly greater than the risk in non-obese patients.

Michelle M Dowsey RN, BAppSc, PhD · Danny Liew MB BS(Hons), FRACP, PhD · James D Stoney MB BS, FRACS, FAOrthA · Peter F M Choong MD, FRACS, FAOrthA

Comparative effectiveness research may stimulate heated debate, but ultimately, those who question its findings need to provide high-quality data to support their arguments One consequence of the continuing rise in the cost of health care has been the emergence of comparative effectiveness research.1 This variant of evidence-based medicine is defined as: . . . the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor a clinical condition, or to improve the delivery of care.1 Furthermore, the purpose of comparative effectiveness research is: . . . to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels.1 When confronted with health care consuming an ever-increasing percentage of the gross domestic product, politicians and policymakers have enthusiastically embraced comparative effectiveness research,2 and Prime Minister Rudd is no exception. In a recent speech, Mr Rudd proclaimed that medical research needed to play a greater role in reducing burgeoning health budgets. “Patients need treatments, technologies and procedures for which there is evidence from research that these are safe and effective.”3 He cited a recent article in the New England Journal of Medicine (NEJM), in which research by an Australian team “found a commonly available treatment for fractures of the bones of the spinal cord was in fact no better than doing nothing at all.”3 He was referring to the treatment of osteoporotic vertebral fractures with vertebroplasty — that is, the percutaneous injection of medical cement into the fractured vertebral body. Such procedures are performed in some 100 000 patients per year in the United States4 and about 700 patients per year in Australia.5 Late last year, this area of practice received a seismic shock when the NEJM simultaneously published two randomised controlled trials (RCTs) — one conducted in Australia6 and one in the US, the United Kingdom and Australia.7 These trials were conducted independently of each other, and both showed that the outcomes of vertebroplasty in patients with osteoporotic vertebral fractures were no different than for a placebo procedure. It was doubtlessly anticipated that publication of these two RCTs would inflame debate, arousing passionate defence of vertebroplasty.4 This is to be expected whenever evidence-based medicine clashes with the collective wisdom of clinical experience. For more than a decade, it had been argued that vertebroplasty was so successful that RCTs were unnecessary or even unethical!4 Not surprisingly, the two RCTs turned the practice of vertebroplasty on its head. In view of the seminal importance of these studies and seeking to inform the broad readership of the Journal, I duly sought an editorial from the lead authors of the NEJM studies, Professor Rachelle Buchbinder from the Monash Department of Clinical Epidemiology at Cabrini Hospital in Melbourne and Professor David Kallmes from Mayo Clinic in Rochester in the US. Then strange things began to happen. Just before the editorial was published, I received an email critical of its content. Then, subsequent to its appearance in the 2 November 2009 issue of the Journal, further emails arrived advising, among other things, that the editorial be retracted. Medical science has always thrived on debate in an open forum, wherein discussion and interpretation of the evidence is to be encouraged. Yet, I was the recipient of closed communications pointing out the weaknesses of the RCTs, as well as suggesting that the reputations of the NEJM and the Medical Journal of Australia had been diminished by the original publication of the RCTs and our subsequent editorial. More sinister, perhaps, is the fact that Professor Buchbinder was subjected to a far more vitriolic campaign, necessitating the threat of legal action (Rachelle Buchbinder, personal communication). In this issue of the Journal, we publish the views of Clark and colleagues, a group of Australian vertebroplasty experts,8 and the rejoinder by Buchbinder and colleagues.9 Clark et al point, among other things, to problems with patient selection and recruitment as a reason for the negative findings of the RCTs, while Buchbinder et al robustly defend the findings and their subsequent interpretation. It is up to the readers of the Journal to decide for themselves whether the two trials and the editorial that sought to interpret them represent the best available evidence on the effectiveness of vertebroplasty. Where do we go from here? It is easy to be critical of study methods, findings and interpretations, but I strongly believe that, when considering important clinical issues, criticisms must not be ad hominen but be supported by new data. It may well be argued that vertebroplasty should no longer be performed except in the context of a study aimed at resolving unresolved questions.4 At the very least, vertebroplasty practitioners should now relate the outcomes of the NEJM trials in their discussions with patients before proceeding to gaining their informed consent.10

Martin B Van Der Weyden MD, FRACP, FRCPA

Our recent editorial in the Journal presents an accurate summary of our two randomised trials of vertebroplasty, which found no benefit of vertebroplasty over placebo. Participants in both trials are representative of patients seen in clinical practice and who would qualify for government-subsidised funding of vertebroplasty in Australia. Clinical experience and previous published literature are likely to have overestimated the treatment benefit of vertebroplasty for many reasons. This is why randomised placebo-controlled trials are required to determine the efficacy of treatment interventions, particularly when the condition being treated is self-limiting and the primary end point is improvement of symptoms. Based on the best evidence currently available, the routine use of vertebroplasty outside of the research setting for painful osteoporotic vertebral fractures appears unjustified.

Rachelle Buchbinder MB BS(Hons), PhD, FRACP · Richard H Osborne BSc, PhD · David Kallmes MD

To the Editor: The editorial by Buchbinder et al suggesting that the effectiveness of vertebroplasty has been determined by the two studies she and her co-authors published1 is misleading. Both studies2,3 contain major flaws. In both, 70% of eligible patients declined to participate. No details of these patients are published, but they may have been the patients with more severe pain. The median duration of pain in the Australian study2 was 9 weeks (compared with 16 weeks in the US study3); only 30% of patients had pain for less than 6 weeks. No information on the need for hospitalisation because of severe pain was given in either study. The average length of hospital stay was not published. In the Australian study, the inclusion criteria were the presence of back pain of less than 12 months’ duration and the presence of one or two recent fractures.2 In this group of patients, whose average age was 74 years, there will be many possible causes of back pain. The fracture may be the main cause of pain, a part-player, or may not be significant. In patients with milder pain and longer duration of pain, non-fracture causes are more likely. In the US study,3 patients were selected on the basis of x-ray unless the fracture “was of uncertain age”. I have performed an audit of my practice and found that in patients with an unequivocal x-ray diagnosis of fracture level, magnetic resonance imaging (MRI) identified another fracture not seen on x-ray in 23 of 63 patients (36%), and in 10 of the 63 patients (16%), a fracture that was presumed acute showed no oedema on MRI. In the Australian study,2 the experience of the radiologists performing the vertebroplasty is not made clear; no details are given about the number of patients they had previously treated. The incidence of osteomyelitis (3.8% at best, 30% at worst, depending on which centre was involved), despite prophylactic antibiotic therapy, is unacceptable. In the US study, injury to the thecal sac in one of 78 patients suggests incompetence. The protocol stated that cement injection was ceased if “cement reached the posterior quarter of the vertebral body or leaked into intraosseous structures”. This sometimes happens after 1 mL of cement has been injected. Experienced operators will perform various manoeuvres to ensure an adequate spread of cement occurs throughout the vertebral body. It would appear this was not done. The volumes of cement injected are not published, except an estimate of “about 3 mL”. The sham procedure was not a true placebo. Injection of local anaesthetic onto the pedicle would likely block the dorsal ramus nerve and provide partial analgesia of the fracture if the fracture extended into the pedicle. Those who perform vertebroplasty regularly see patients who are bedridden, in severe pain, intolerant of analgesics, and who have undergone various procedures including epidural injections or facet joint injections without benefit, and who then respond to vertebroplasty within 24 hours. Efforts should be aimed at refining technique and patient selection, rather than throwing out the baby with the bathwater on the basis of inappropriate studies.

Paul J Graziotti

To the Editor: Clinical trials study a restricted patient group, so their results may not be generalisable to a different population subgroup or the population as a whole. The editorial by Buchbinder, Osborne and Kallmes1 about their recent vertebroplasty studies2,3 concludes that vertebroplasty offers no benefit over placebo. They suggest that, in light of their trials, the decision to list vertebroplasty on the Medical Benefits Schedule will be reviewed later this year. I understood the review to have been part of the original listing on the benefits schedule and not as a result of their studies, and I suggest that their editorial generalises results to a subpopulation of early acute vertebral fractures that they did not study. The duration of symptoms in osteoporotic vertebral fracture is critical, as most fractures heal quickly with a good outcome by 3 months, and only a very small group of patients continue to experience pain.4 A fracture that is still painful months after the event is not a “normal fracture”, and I suggest is less likely to respond to the same management concepts as an acute fracture. In the study by Buchbinder and colleagues, patients had persistent pain and were recruited up to 1 year after their vertebral fracture.2 Nearly three-quarters had significant ongoing pain for at least a month after their fracture, and most for at least 2 months. The study by Kallmes and colleagues also included symptomatic fractures up to 1 year old, with the interquartile range (8–38 weeks) suggesting that they had an even longer period between fracture and inclusion in the trial.3 While vertebroplasty appears to be unhelpful for patients who continue to have chronic pain months after an acute osteoporotic fracture, the authors have not robustly excluded vertebroplasty as improving quality of life and pain management in those who undergo vertebroplasty within days to a month of the fracture. Such an outcome is suggested by Rousing et al, who showed that vertebroplasty within 2 weeks of fracture led to a rapid reduction in pain within 12–24 hours, similar to the result of conservative management at 3 months.4 Any review of the role for vertebroplasty should consider the populations studied and, hence, should define the characteristics of patients in whom to intervene or not intervene.

Kevin D Pile

In reply: The letters by Graziotti and Pile raise spurious issues that in no way threaten the key message of our trials. Participation rates in both trials were better than other controlled trials of vertebroplasty or kyphoplasty.1,2 Eligible patients who declined enrolment in the Investigational Vertebroplasty Efficacy and Safety Trial (INVEST) had similar levels of pain and disability to those who participated.3 Both trials adhered to stringent eligibility criteria, ensuring that only patients with pain due to acute or subacute fractures were included. All operators were trained and experienced, and the low incidence of serious adverse effects in both trials is consistent with the literature. There is no evidence that the outcome of vertebroplasty is influenced by cement distribution or volume.4 Local anaesthetic infiltration of the periosteum of the pedicles, as occurred in one trial,3 is unlikely to have a sustained effect. As Pile points out, most osteoporotic vertebral fractures heal quickly; this implies that most people would be unlikely to benefit from early invasive intervention. Consistent with this, public funding for vertebroplasty in Australia only has interim approval for patients whose pain is not controlled by conservative medical therapy. While duration of medical therapy is not specified, historically, this has ranged from at least 4 to 6 weeks. Thus, both trials included patients similar to those who would qualify for government-subsidised funding of the procedure in Australia. While Pile acknowledges that vertebroplasty appears to be of no value in patients with persisting symptoms (the group most likely to derive benefit), he seems to suggest that it may have a role in early treatment (within days to a month). As well as being at odds with his earlier statement, this is not supported by the available data. Many participants in both trials had short symptom duration (Australian trial, 32% < 6 weeks; INVEST, 20% < 6 weeks and 41% ≤ 13 weeks), and neither trial found evidence that symptom duration was a treatment effect modifier. The trial by Rousing et al reported comparable outcomes from vertebroplasty and conservative treatment in patients with acute symptoms (40 patients, < 2 weeks; 10 patients, 2–8 weeks).5 While no data were presented, the immediate (12–24 hours) benefit from vertebroplasty reported in this open study, like clinical experience, could be attributable to many factors including local anaesthesia, regression to the mean, and expectation bias. The onus remains on proponents of vertebroplasty to prove that any benefits of vertebroplasty outweigh the potential risks.

Rachelle Buchbinder · Richard H Osborne · David Kallmes

Objective: To update evidence-based guidelines for the treatment of proximal femoral fractures published in the Journal in 2003.Data sources: Systematic search of MEDLINE, CINAHL and EMBASE for articles published from October 2001 to June 2008, and the Cochrane Database of Systematic Reviews (most recent issue searched — Issue 2, 2008).Study selection: Randomised controlled trials and meta-analyses of all aspects of acute-care hospital treatment and rehabilitation for proximal femoral fractures among participants aged 50 years or older with proximal femoral fractures not associated with metastatic disease or multiple trauma.Data extraction: All studies were reviewed independently by two assessors, who recorded individual study results, and an assessment of study quality and treatment conclusions was made according to Cochrane Collaboration protocols. If necessary, a third review was performed to reach consensus.Results: 128 new studies were identified and 81 met our inclusion criteria. Recommendations for time to surgery, thromboprophylaxis, anaesthesia, analgesia, prophylactic antibiotics, surgical fixation of fractures, nutritional status, mobilisation and rehabilitation have been updated. Also, recommendations regarding surgical wound closure, management of postoperative delirium, osteoporosis treatment and hip protectors have been added. The guidelines include the current National Health and Medical Research Council grades of recommendations for clinical guidelines.Conclusions: Significant changes in recommendations have been made, particularly in relation to surgery, rehabilitation and tertiary prevention. Hip fracture should be treated according to the most up-to-date evidence to achieve the best possible outcomes and optimal use of limited resources.

Jenson C S Mak MB BS, FRACP, FAFRM(RACP) · Ian D Cameron MB BS, PhD, FAFRM(RACP) · Lyn M March MB BS, PhD, FRACP

Two randomised placebo-controlled trials show the importance of establishing the efficacy of procedures before adopting them into clinical practice Vertebral fractures are a common manifestation of osteoporosis, and up to half such fractures result in severe pain and disability. Although most heal within weeks or a few months, some people experience persisting discomfort. Best supportive care includes bed rest, analgesia and physical therapy, and some patients require hospitalisation. Vertebroplasty, the percutaneous injection of polymethylmethacrylate (PMMA) into the affected vertebral body, has been widely accepted to be a safe and effective treatment for vertebral fractures on the basis of observational and quasi-experimental studies.1 Despite a lack of evidence from randomised controlled trials on which to base reimbursement decisions, some countries, including Australia, have recommended public funding of the procedure.2,3 Since being listed on the Medicare Benefits Schedule in November 2005, about 600 to 700 vertebroplasties have been performed in Australia annually (not including those performed in public hospitals),4 and at least 40 000 are performed in the United States annually.5 The results of the first two randomised placebo-controlled trials investigating this procedure have now been published in the New England Journal of Medicine.6,7 In the first study, performed in Australia, 78 participants with one or two acute osteoporotic vertebral fractures were randomly assigned to undergo either vertebroplasty or a placebo procedure (Box 1).6 To simulate the real procedure, patients in the placebo group underwent gentle tapping of a stylet resting on the affected vertebral body, and PMMA was prepared so that its smell permeated the room. All participants and research personnel other than those performing the procedure were blinded to treatment allocation. Vertebroplasty did not result in a significant advantage over placebo in any measured outcome at any timepoint, and pain reduced in both the treatment and placebo groups over time (Box 1). Similar improvements were seen in both groups with respect to pain at night and at rest, physical functioning, quality of life, and perceived improvement. Seven new vertebral fractures (three in the vertebroplasty group and four in the placebo group) occurred during the 6 months of follow-up, and one of these patients in the vertebroplasty group also developed osteomyelitis. In the second study, which was based in the US, but also included sites in the United Kingdom and Australia, 131 patients with between one and three painful osteoporotic vertebral fractures were randomly assigned to undergo vertebroplasty or a sham procedure (Box 2).7 The control group underwent local infiltration with local anaesthetic, but no stylet was inserted, and PMMA was also prepared so that the odour would permeate the room. Patients in both groups were allowed to cross over to the other procedure at 1 month or later if they wished because adequate pain relief had not been achieved. As in the Australian study, there were no clinically or statistically significant differences between groups at any timepoint up to, and including, 1 month for any of the primary or secondary outcomes measured. At 1 month, there was no significant difference between the treatment and control groups on either the Roland Morris Disability Questionnaire or the pain rating. One patient in the vertebroplasty group had an injury to the thecal sac during the procedure, resulting in the patient requiring hospitalisation. The negative findings of these two trials are supported by the findings of two open randomised trials of vertebroplasty versus usual care.8,9 One of these included 34 participants, and allowed crossover to the vertebroplasty group after 2 weeks in cases of persisting pain.8 At 2 weeks, the mean pain scores were similar between the two groups. The other open randomised trial included 50 patients who had had a short duration of symptoms (40 patients, < 2 weeks; 10 patients, 2–8 weeks).9 Outcomes at 3 months indicated no differences between the vertebroplasty and usual care groups for any of the measured endpoints. There were two adjacent fractures in the group that underwent vertebroplasty and none in the usual care group. These trials provide the best evidence we have to date on the value of vertebroplasty for treating painful osteoporotic vertebral fractures. Based on these data, vertebroplasty appears to confer no benefit over placebo, but poses some risk. Apart from the immediate risks of cement leakage, infection and injury to the spinal cord, vertebroplasty may increase the risk of further vertebral fracture. Both the Australian and US studies are ongoing, and will provide valuable additional data on this risk. Lower-quality studies are often biased in favour of interventions that are later shown in high-quality controlled trials to be ineffective.10 Findings from our two methodologically rigorous, randomised placebo-controlled trials show, not for the first time, the importance of establishing the efficacy of new procedures in well conducted, appropriately designed clinical trials before they are widely promoted and adopted into clinical practice. In light of the new evidence, the decision to list vertebroplasty for the treatment of osteoporotic vertebral fractures on the Medicare Benefits Schedule will be reviewed by the Medical Services Advisory Committee later this year. Treatment of painful vertebral fractures should continue to be best supportive care focused on pain management and maximising function. Attention to minimising risk of further fracture, including treatment of osteoporosis and other risk factors is also advisable. 1 Summary of the Australian randomised controlled trial of vertebroplasty6 National Health and Medical Research Council (NHMRC) Level of Evidence: II (randomised controlled trial) Location: Melbourne, Victoria Funding: NHMRC, Arthritis Australia, Cabrini Institute, Cook Australia Conclusion: Vertebroplasty was no better than placebo up to 6 months Description and findings 78 patients with one or two acute painful osteoporotic vertebral fractures confirmed unhealed by magnetic resonance imaging. 38 underwent vertebroplasty, and 40 underwent a placebo procedure simulating the real procedure. Follow-up was complete to 6 months for 71 of 78 patients (91%). The primary endpoint was overall pain over the course of the previous week (on a numerical scale of 0 to 10, with 10 being the maximum imaginable pain) at 3 months. Median duration of pain was 9.5 weeks for the vertebroplasty group and 9 weeks for the placebo group. Pain reduced in both groups over time. No differences between treatment groups were observed for any measures at any time point. At 3 months, the mean reduction in pain was 2.6 points (SD, 2.9) in the vertebroplasty group and 1.9 points (SD, 3.3) in the placebo group (adjusted between-group difference, 0.6; 95% CI, − 0.7 to 1.8). There were seven incident clinical vertebral fractures (three in the vertebroplasty group and four in the placebo group) over 6 months. One patient who underwent vertebroplasty and developed a new adjacent fracture also developed osteomyelitis. 2 Summary of the Mayo Clinic-based randomised controlled trial of vertebroplasty7 National Health and Medical Research Council Level of Evidence: II (randomised controlled trial). Location: Mayo Clinic in the United States (primary site); sites in the United Kingdom and in Sydney, New South Wales. Funding: National Institutes of Health. Conclusion: Vertebroplasty was no better than placebo up to 1 month. Description and findings 131 patients with one to three acute painful osteoporotic vertebral fractures confirmed unhealed by magnetic resonance imaging. 68 underwent vertebroplasty and 63 underwent a sham procedure. Crossover was allowed at 1 month if desired. Primary endpoints were the modified Roland Morris Disability Questionnaire (on a numerical scale of 0 to 23, with 23 being the maximum possible disability) and patients’ ratings of average pain intensity during the preceding 24 hours (on a numerical scale of 0 to 10, with higher scores indicating more severe pain) at 1 month. Median duration of pain was 16 weeks for the vertebroplasty group and 20 weeks for the placebo group. Pain reduced in both groups over time. No differences between treatment groups were observed for any other measures at 1 month. At 1 month, there was no significant difference between the vertebroplasty and control groups on either the Roland Morris Disability Questionnaire (difference, 0.7; 95% CI, − 1.3 to 2.8) or the pain rating (difference, 0.7; 95% CI, − 0.3 to 1.7). One patient who underwent vertebroplasty had an injury to the thecal sac during the procedure that made hospitalisation necessary.

Rachelle Buchbinder MB BS(Hons), PhD, FRACP · Richard H Osborne BSc, PhD · David Kallmes MD

Clinical record An 8-year-old Indigenous Australian boy was transferred from a regional hospital to a metropolitan paediatric hospital, with fevers, 2 weeks of left hip and thigh pain, and a left thigh abscess that had begun to discharge. Two weeks earlier, he had fallen while rollerblading and had sustained a superficial wound on the left thigh. He complained of ongoing left hip and groin pain and presented on several occasions to his general practitioner, who diagnosed a soft tissue injury. On arrival, the patient was in septic shock. Outside-taken radiographs (Figure, A) and magnetic resonance imaging (MRI) (Figure, B) showed extensive osteomyelitis and bony destruction, focused at the left ischium. The necrotic ischium, pubis and hamstrings were debrided and large purulent collections were drained from the thigh; swabs were taken for microbiological culture. The initial debridement did not involve the exploration of the internal aspect of the pelvis. During a second debridement, 48 hours later, the pus had a faeculent odour and colour. Bowel involvement was not detected at this stage. During the third debridement, 5 days after the initial surgical treatment, faeculent fluid drained freely from the wound and further exploration revealed a retroperitoneal sigmoid colon perforation. The general surgical team created a colostomy and the wound was packed with gentamicin antibiotic beads and covered with a vacuum dressing. Two strains of Escherichia coli, mixed anaerobes, Candida species and non-multiresistant, methicillin-resistant Staphylococcus aureus were cultured from the samples taken during the initial debridement. The patient was treated with oral clindamycin and rifampicin. After almost 9 weeks in hospital, he was discharged with a prescription for these antibiotics to be taken for 1 year. The patient’s colostomy was reversed at 6 months with no complications. One year after discharge, the boy had a 3 cm leg length discrepancy and reduced range of motion of his left hip. An MRI scan 1 year after discharge showed regeneration of the ischium and pubis, avascular necrosis of the left femoral head and formation of a left hip pseudoarthrosis (Figure, C). Despite radiographic changes, at follow-up he was surprisingly active, could walk over 1 km without pain, participated in sport (including soccer), and rarely needed analgesics. A: Outside-taken plain anterior–posterior pelvis radiograph showing left hip subluxation, bony changes in the ischium, ilium and pubis, and distended small bowel. B: MRI at initial presentation showing large medial thigh collection (large arrow), left hip subluxation and oedema in the soft tissue, and fluid collection in the retroperitoneum (small arrow). C: MRI of the pelvis 1 year after discharge showing partial resorption of the left acetabulum and confirming avascular necrosis of the left femoral head (arrow). Pelvic osteomyelitis is a rare occurrence, with reported rates of 1%–11% of all cases of acute haematogenous osteomyelitis (AHO) occurring between the ages of 7 and 14 years.1 In a review of the medical records of 220 children with AHO, 19 children had pelvic osteomyelitis.2 A review of cases of AHO at our institution showed infection of the pelvis in 8% of 102 patients with AHO and a male : female ratio of 2.1 : 1.3 Pelvic osteomyelitis has been described in three entities — gluteal, lumbar and abdominal.4 Although these designations can be useful for determining the spread of infection, they have no prognostic value.4,5 Acute pelvic osteomyelitis is often not initially recognised. It can be difficult to detect due to its variable clinical signs and differential diagnoses.1 In one study, the time span between initial symptoms and the diagnosis ranged from 1 to 8 days.2 Difficulty diagnosing the condition may result in a delay of appropriate treatment.1,6,7 In our patient, plain radiographs (which are usually normal for the first 7–10 days8) and magnetic resonance imaging (MRI) scans showed extensive bony and soft tissue destruction of the left hemipelvis, hip and thigh. Is it plausible that these changes occurred within 2 weeks, considering the patient’s history? As we were unable to find supporting reports in the literature, this matter was discussed within various hospital departments. Concerns were raised that the time frame was too short to cause this level of destruction. It was proposed that the mixed flora that were cultured could cause a high level of destruction within 14 days. Although plausible, there was no direct evidence to support this theory. When during the course of the infection did the bowel perforation occur? In the literature, we found two case reports of a bowel perforation associated with pelvic osteomyelitis. Both occurred in adult patients, and bony infection was secondary to Crohn disease in both cases.9,10 On arrival at our hospital, our patient’s radiographs showed dilated loops of bowel and no signs of free gas. The MRI scan showed oedema and signs of inflammation of the soft tissue at the perineum, surrounding the rectum, urethra, bladder and sigmoid colon. Free fluid was seen within the pelvis; however, there was no obvious pelvic collection. Enteric flora were cultured from the initial intra-operative swabs. These factors indicate that the bowel perforation was probably present on arrival, possibly as a sealed perforation, which was only detected 5 days after the initial debridement. Although we were unable to ascertain the cause of the bowel perforation, we believe that its association with pelvic osteomyelitis was significant. We recommend that sophisticated imaging studies be performed at an early stage. MRI is the most sensitive test for osteomyelitis of the pelvis and spine, with a reported sensitivity of 97%–100% and specificity of 73%–92%.11 Staphylococcus aureus is the most common causative organism in AHO, accounting for 76% of cases, with an increased emergence of community-acquired methicillin-resistant Staphylococcus aureus (MRSA) accounting for 9% of these.3 Aggressive community-acquired MRSA, which was isolated from the initial swabs, was thought to be the causative organism of this patient’s pelvic osteomyelitis. We believe that the late diagnosis and the bowel perforation contributed to the extraordinary tissue destruction described in this article. We believe that the extent of the patient’s recovery, including the partial repair of bony destruction, was remarkable. Most cases of pelvic osteomyelitis reported in the literature were treated adequately with antibiotics alone; surgical intervention was rarely required.1,5 Complications, including recurrence and permanent sequelae, were uncommon, with rates reported between zero and 7%.1,5 Increasing rates of community-acquired MRSA require clinicians to consider whether a change to more efficacious antibiotic therapy is necessary if the patient is not responding to flucloxacillin alone. Unusual circumstances that delay the diagnosis can always occur, particularly in rural communities, where access to sophisticated imaging is limited. Lessons from practice Negligible accidents can form the starting point of life-threatening osteomyelitis, particularly in the pelvic region. To avoid major complications, it is important to repeat physical examinations within a short time period (ie, daily). If any doubt arises regarding a correct diagnosis, check for inflammatory parameters and refer the patient to a major hospital for sophisticated imaging and commencement of appropriate treatment. Consider magnetic resonance imaging early, as this is the most sensitive method for detecting (pelvic) osteomyelitis.

Craig D Hughes BSc, BM BS · Matthias W Axt BM BS, FRACS

A 77-year-old man with no significant medical history presented to the orthopaedic clinic of a metropolitan hospital with longstanding left mechanical knee pain. Examination and x-ray revealed features consistent with degenerative arthritis (Figure, A), and he subsequently underwent total knee arthroplasty. During surgery, a bluish-black pigmentation of the bone and the cartilage of the knee joint was noted (Figure, B). The patient’s surgery and recovery were uneventful. It was later discovered that he had a previously undiagnosed rare metabolic disorder, alkaptonuria, which affects one in 250 000 to 1 000 000 people worldwide.1 Alkaptonuria was one of the first inborn errors of metabolism to be described, in 1908.2 It is caused by mutations in the homogentisate 1,2-dioxygenase (HGD) gene, which results in a deficiency of HGD, which catabolises homogentisic acid (HGA). This leads to accumulation and deposition of HGA in cartilaginous tissues, causing a bluish-black discolouration (ochronosis).3 Ochronosis is generally asymptomatic, but ochronotic arthropathy due to deposition of pigments in the joints is common.3 The patient also had the characteristic ochronotic discolouration in the sclera (Figure, C), ear cartilage, fingernails and buccal mucosa, but did not report dark urine. The gene defect was not further investigated because of his age and excellent premorbid health status.

See-Seong Chang · Eugene T Ek · Vicki Pliatsios

Albert (“Bert”) Bencsik was born on 15 October 1931, the only child of Hungarian immigrants recently arrived in Australia. The family lived in Rose Bay, and Bert attended Woollahra primary school and Sydney Technical High School, where he was a prefect. After graduating from the University of Sydney in 1956, Bert did his residency at the Mater Misericordiae Hospital, Crows Nest. In 1960, he travelled as a ship’s surgeon to the United Kingdom, where he worked in Portsmouth, London and Edinburgh and became a Fellow of the Royal College of Surgeons of Edinburgh in 1964. Returning to Sydney after completing his Fellowship, he worked as a Surgical Registrar at St George Hospital from 1964 until 1966. During this time, he was a founding member of the Resident Medical Officers Association and an Honorary Medical Officer for the Australian Racing Drivers Club. In 1967, Bert joined the Australian orthopaedic training scheme, and in 1970 commenced private orthopaedic practice in Chatswood and Kogarah, and later also in Canterbury and Bankstown. He was an Honorary Medical Officer, subsequently Visiting Medical Officer, at St George and Canterbury hospitals. He developed a special interest in hand surgery and was secretary of the New South Wales Hand Surgery Association. Together with Bill Cumming, almost 40 years ago, he founded the St George Hospital hand clinic, which gradually developed into a first-class trauma unit. He was strongly involved in the St George Hospital Orthopaedic Skills Laboratory, which was the first and largest fully equipped such facility in the world. Positions Bert held included honorary convenor of the Papua New Guinea orthopaedic registrar training program, examiner for the Australian Orthopaedic Association Board of Studies, and founding honorary secretary of the Med-Law Association of NSW. Bert was a careful, unhurried, caring clinician whose demeanour instilled great confidence in his patients. After retiring from elective surgery in 1997, he continued to consult, particularly in medicolegal matters. In his leisure time, Bert was an avid gardener who designed and cultivated a beautiful garden at his home, “Ysabel”, in Hunters Hill. He was a lover and connoisseur of fine wines and food, and delighted in attending meetings of the Tipplers Wine Club, of which he was a founding member. He also had more than 70 letters, on a wide range of subjects, published in the Sydney Morning Herald from 1964 to 2007. Bert died on 26 June 2008 of acute renal failure and prostate carcinoma. He is survived by his children Michael, Susan, Catherine and Nicholas, and seven grandchildren, to whom he was devoted.

William J Barnett

The mark, especially the “high mark” and “spectacular grab”, distinguishes Australian Rules football from more earthbound varieties.1 Photographs taken at a recent South Australian National Football League match revealed a high mark where hyperextension of the proximal interphalangeal joint of the right index finger occurred. Interview with the player and examination of the affected digit 4 days after the match revealed no injury to the finger, although some bruising of the right thenar web space and mild tenderness of the first metacarpophalangeal joint were evident. A previous report concluded that virtually all pure hyperextension injuries of the proximal interphalangeal joint result in rupture of the distal end of the volar plate,2 but fracture dislocation appears to depend on joint angle at the time of injury.3 A review of published literature and photographic libraries failed to reveal a similar incident. Further research is required to characterise the biomechanical forces necessary to cause digital injury in sports requiring barehanded capture of a travelling ball.

Robert J Douglas

To the Editor: We read with interest the recent article by Oldmeadow and colleagues.1 Patients on waiting lists have long waits and poor quality of life,2 and we are currently piloting a similar model for assessment of patients referred for orthopaedic opinion for hip and knee arthroplasty.3 In keeping with other authors, the article by Oldmeadow and colleagues provides encouraging data to support role substitution. However, we suggest that important issues need to be addressed before wide-scale adoption and expansion of the model. More information is needed about the proportion of all referred patients eligible for the physiotherapist assessment, and the cost–benefit figures for “avoided” orthopaedic consultations. It is quite difficult to evaluate the outcomes given the exclusion criteria, which are common comorbidities in these settings. While the κ statistic implies concordance between two physiotherapists and one surgeon, the disagreement was still about one patient in four. Of course, this level of disagreement may also be found between surgeons. However, for a new health intervention, such discordance needs to be understood within an appropriate evaluation framework. What level of diagnostic error are consumers prepared to accept from any health care provider? The article reports five episodes of disagreement between the physiotherapists and the surgeon, where the need for surgery, medical treatment or further imaging was missed; this represents 13.2% of patient assessments (were there multiple missed opinions in individual cases?). The fact that a patient refused surgery is irrelevant if that decision was not identified a priori before surgical referral. Every consumer has the right to accept or reject recommendations about care based on the best available information about potential benefits and harms. An important role of specialist medical providers is that of diagnostician, particularly when there are multiple or complex conditions. Changes to the management of common musculoskeletal conditions should not reduce opportunities for expert input when required. Waiting times for many patients are clinically and ethically unacceptable and we agree new service delivery models are necessary. We suggest that: professional groups work together to develop agreed evidence-based protocols for triage, assessment, investigation and management of common musculoskeletal conditions; funding providers and health care organisations develop and evaluate new models of care, including their cost-effectiveness, and provide appropriate training and monitoring to ensure role redefinition is associated with maintenance of equal or better quality and safety of care; and a musculoskeletal clinical network be developed to support these objectives.

Caroline A Brand · Richard H Osborne · Ian P Wicks · Richard N de Steiger

In reply: The proportion of patients who, after being referred to specialist orthopaedic surgeons by general practitioners, are then listed for surgery, is around 20%–30%.1-3 In our trial, the diagnostic and management concordance between the physiotherapists and surgeon for this group was very high. It was also high for the 63% for whom evidence-based physiotherapy was appropriate. Management discordance occurred when surgical treatments that are controversial, and variously used by surgeons (as noted by Brand and colleagues), were recommended. It is important to note that the 74% agreement between the surgeon and physiotherapists in our trial was achieved under research conditions, with the physiotherapists screening independently. We suggest that the physiotherapist clinic be co-located with that of the surgeons, to facilitate further investigations, enhance the pathway to surgery and manage safety concerns. The advantages of a physiotherapist screening clinic are in (i) triaging out from waiting to see a surgeon, patients predicted to benefit from non-surgical interventions (including those not willing to consider surgery at the time) and (ii) triaging patients in to the appropriate non-surgical care. We agree that patients with degenerative, osteoarthritic conditions, for whom joint replacement surgery may be the eventual treatment, will be best managed through multidisciplinary care.

Leonie B Oldmeadow · Harvinda S Bedi · Hugh T Burch · Jenni S Smith · Edmund S Leahy · Miron Goldwasser

The practice of “medical tourism” is gaining popularity. Lower costs and shorter waiting times are compelling motivating factors. There are also increasing commercial interests promoting medical tourism. There are very limited clinical data to support or refute this practice. However, medical tourism breaks important elements in the traditional health care model, including patient selection, continuity of care, and practice auditing. When complications arise, challenges specific to medical tourism patients may be encountered.

Ian K Cheung MB BS · Anthony Wilson MB BS, FRACS

Objective: To determine the relationship between compensable status in a “no-fault” compensation scheme and long-term outcomes after orthopaedic trauma.Design and setting: Prospective cohort study within two adult Level 1 trauma centres in Victoria, Australia.Participants: Blunt trauma patients aged 18–64 years, admitted between September 2003 and August 2004 with orthopaedic injuries and funded by the no-fault compensation scheme for transport-related injury, or deemed non-compensable.Main outcome measures: 12-item Short Form Health Survey (SF-12) and return to work or study at 12 months after injury.Results: Of 1033 eligible patients, 707 (68.8%) provided follow-up data; 450 compensable and 247 non-compensable patients completed the study. After adjusting for differences across the groups (age, injury severity, head injury status, injury group, and discharge destination) using multivariate analyses, compensable patients were more likely than non-compensable patients to report moderate to severe disability at follow-up for the physical (adjusted odds ratio [AOR], 2.0; 95% CI, 1.3–2.9), and mental (AOR, 1.6; 95% CI, 1.1–2.5) summary scores of the SF-12. Compensable patients were less likely than non-compensable patients to have returned to work or study, even after adjusting for injury severity, age, head injury status and discharge destination (AOR, 0.6; 95% CI, 0.3–0.9).Conclusions: Patients covered by the no-fault compensation system for transport-related injuries in Victoria had worse outcomes than non-compensable patients.

Belinda J Gabbe BPhysio(Hons), MAppSc, PhD · Peter A Cameron MB BS, FACEM · Owen D Williamson GradDipEpi, FRACS, FAOrtho · Elton R Edwards MB BS, FRACS, FAOrthA · Stephen E Graves DPhil, FRACS, FAOrthA · Martin D Richardson MS, FRACS, FAOrthA

Outcomes for patients must be a core variable in this complex research The report by Oldmeadow and colleagues (→ Experienced physiotherapists as gatekeepers to hospital orthopaedic outpatient care) in this issue of the Journal details an evaluation of assessment by physiotherapists as an alternative to orthopaedic surgeon management of patients referred by general practitioners for musculoskeletal conditions.1 The authors describe a service funded by the “Better Skills, Best Care” initiative of the Victorian Department of Human Services, whereby two highly qualified physiotherapists screened patients with uncomplicated conditions before parallel assessment by a surgeon. Their conclusions were that the service was beneficial (reduced waiting lists), acceptable (with good levels of satisfaction among all stakeholders) and of high quality (most physiotherapist management decisions were in accord with those of the surgeon). Oldmeadow and colleagues directly address a topic of real importance, as highlighted by the July 2006 issue of the Journal, devoted to task transfer.2 Their findings support what is happening in other countries, particularly the United Kingdom, where the practice of substituting physiotherapists and other allied health professionals (AHPs) for medical personnel has increased over the past 5 years. These changes are taking place largely in response to: increased waiting lists; shortage of medical staff in specific disciplines; AHP aspirations; and, indeed, politics, with efforts to modernise the National Health Service.3 A number of studies have now shown that nurses,4 AHPs,5 and staff specifically trained as physician assistants6 can take on a number of tasks and roles usually performed by doctors. Perhaps the fact that different health care staff are clearly able to learn and apply new skills and techniques should no longer be surprising. While welcoming evaluation of new approaches to care when translated from one environment to another, this report and other research about new roles prompts some key questions, including: Are the right people with musculoskeletal pain on tertiary care waiting lists? When is the physiotherapist the best person to see patients with musculoskeletal pain? Does “impact” mean the same thing in workforce research as it does in other clinical research? As waiting lists for hospital treatment in most countries grow, it is paramount to find the best ways of minimising the number getting onto those lists in the first place. Speedy exit from the list certainly reduces waiting lists, and increased resource allocation to tertiary services currently seems a central strategy, with reports of waiting list difficulties being rare in countries with comparatively greater expenditure on health.7 Without additional resource allocation into health, it would seem sensible to maximise referral of those who have potential to gain from surgical opinion (ie, appropriate targeting) and minimise referral of those who actually have little to gain. It has been noted that in the management by GPs of hip and knee pain in over 300 000 British patients over the age of 65, only 2% were referred to physiotherapy at the initial consultations, increasing to 11% if the patients had been seen again within 12 months, and to 17% if they were seen again within 36 months.8 As the patients in this study had a high proportion of degenerative joint disease, they would arguably benefit from highly skilled physiotherapy rather than referral for orthopaedic assessment, given that physiotherapy has been shown to be effective at reducing pain and medication use9-11 and improving function10,12 in patients with degenerative joint disease of the knee. In many developed countries, clinical guidelines have been developed to guide GPs and other health professionals as to when referral to an orthopaedic surgeon is required and appropriate.13,14 Given the high numbers of people on waiting lists, maybe more needs to be done to increase the usability and use of, and reward for using, such guidelines. There must also be some surety of access to physiotherapy, in view of warnings about a serious shortage of therapists by the Australian Physiotherapy Association.15 If the whole workforce system is not considered, we may simply find excessive waiting lists for surgical review are replaced by excessive waiting lists for physiotherapists. At the heart of any question about patient management should be: “What is the best treatment for this particular patient at this point in time?” If we forget this, we may actually fail to use and develop our workforce in the most effective and cost-efficient way. While having very experienced physiotherapists working as “consultant” practitioners makes sense, is having them predominantly perform duties as an alternative to consultant physicians or surgeons the best approach? While Oldmeadow et al restricted their sample to uncomplicated musculoskeletal pain, and excluded patients with psychosocial issues that contribute to symptom chronicity, we suggest that those with psychosocial issues may be one of the very groups who could benefit most from an enhanced physiotherapy intervention. The enhanced scope here would go beyond advanced skills in assessing joint impairment and function. Rather, the physical and technical skills would be augmented by the knowledge, ability and confidence to consider the psychosocial factors that frequently perpetuate painful conditions and lead to enduring disability. A novel intervention was recently described, in which AHPs (including physiotherapists) were trained to deliver a brief psychosocial intervention to complement the usual scope of physical therapy in patients with musculoskeletal pain.16 While this sample was different from that in the report by Oldmeadow et al (the patients were not on waiting lists for surgery, having either had surgery, or having been assessed as not requiring surgery), the rate of return to work for those with the expanded scope treatment was 25% better than for those with usual physical therapy alone. This indicates a different motivation for, and approach to, task substitution or role replacement, and one that seems to achieve good outcomes for patients. Oldmeadow et al aimed to evaluate the “impact, quality and acceptability” of the intervention and concluded that physiotherapists were competent and safe in this intervention. While it certainly appears that all the stakeholders involved found the service acceptable (with the caveat that satisfaction is a particularly tricky area to measure well), evidence about impact, quality, safety and competence are complex, and may require more complex methods of assessment to be persuasive. Shorter waiting lists are indeed one effect of an intervention, but without knowing eventual outcomes for patients, that effect may be of dubious relevance. If the dominant approach to evaluation in task substitution/enhancement research remains predominantly to do with output (such as waiting list reduction), we will really have little idea of which approach to the development of new roles is most likely to be beneficial. We agree with Oldmeadow et al that more research into new roles is required. Definitive answers to important questions are needed, and it is important that the complexity involved in this type of research is not overlooked.17 In particular, patient health outcomes must be a core variable in that mix of complexity if we are to make persuasive statements about impact, quality, safety and competence.

Kathryn M McPherson PhD · Duncan A Reid MHSc(Hons), PgDipHSc, DipPhys