Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): study protocol for a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture [ISRCTN22464643].

BACKGROUND: Proximal femoral fracture is a common, major health problem in old age resulting in loss of functional independence and a high-cost burden on society, with estimated health and social care costs of £2.3 billion per year in the UK. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of effectiveness is lacking. Usual rehabilitation care is delivered by a multi-disciplinary team in the hospital and in the community. An 'enhanced rehabilitation' intervention has been developed consisting of a workbook, goal-setting diary and extra therapy sessions, designed to improve self-efficacy and increase the amount and quality of the practice of physical exercise and activities of daily living. METHODS/DESIGN: This paper describes the design of a phase II study comprising an anonymous cohort of all proximal femoral fracture patients admitted to the three acute hospitals in Betsi Cadwaladr University Health Board over a 6-month period with a randomised feasibility study comparing the enhanced rehabilitation intervention with usual care. These will assess the feasibility of a future definitive randomised controlled trial and concurrent economic evaluation in terms of recruitment, retention, outcome measure completion, compliance with the intervention and fidelity of delivery, health service use data, willingness to be randomised and effect size for a future sample size calculation. Focus groups will provide qualitative data to contribute to the assessment of the acceptability of the intervention amongst patients, carers and rehabilitation professionals and the feasibility of delivering the planned intervention. The primary outcome measure is function assessed by the Barthel Index. Secondary outcomes measure the ability to perform activities of daily living, anxiety and depression, potential mediators of outcomes such as hip pain, self-efficacy and fear of falling, health utility, health service use, objectively assessed physical function and adverse events. Participants' preference for rehabilitation services will be assessed in a discrete choice experiment. DISCUSSION: Phase II studies are an opportunity to not only assess the feasibility of trial methods but also to compare different methods of outcome measurement and novel methods of obtaining health service use data from routinely collected patient information. TRIAL REGISTRATION: Current Controlled Trials ISRCTN22464643, UKCRN16677.

Does pre-operative psychological distress affect patient satisfaction after primary total hip arthroplasty?

BACKGROUND: There are concerns that pre-operative psychological distress might be associated with reduced patient satisfaction after total hip replacement (THR). METHODS: We investigated this in a multi-centre prospective study between January 1999 and January 2002. We dichotomised the patients into the mentally distressed (MHS ≤ 56) and the not mentally distressed (MHS > 56) groups based on their pre-operative Mental Health Score (MHS) of SF36. RESULTS: 448 patients (340 not distressed and 108 distressed) completed the patient satisfaction survey. Patient satisfaction rate at five year was 96.66% (415/448). There was no difference in patient satisfaction or willingness to have the surgery between the two groups. None of pre-operative variables predicted five year patient satisfaction in logistic regression. CONCLUSIONS: Patient satisfaction after surgery may not be adversely affected by pre-operative psychological distress.

Misdiagnosis of occult hip fracture is more likely in patients with poor mobility and cognitive impairment.

The diagnosis of occult hip fracture is frequently missed. We wished to investigate if patients in whom occult hip fracture was initially misdiagnosed had any distinct features, and their outcome. We reviewed 297 patients who presented with hip fractures over a two-year period. There were 24 occult hip fractures, the diagnosis was initially missed in 9 patients and correctly made in the other 15. Of the correctly identified patients, 8/15 were independently mobile and 9/15 were living in their own home compared to 0/9 independently mobile and 2/9 living in own home among those with missed diagnosis (p < 0.001). Seven of nine patients with a missed diagnosis had mental confusion but none in the other 15 (p < 0.001). Eight of the nine patients with missed diagnosis of fracture had intra-capsular fractures, of which 6 secondarily displaced. Three of those nine patients died within one year from their fracture. We suggest a low threshold of investigation for occult hip fracture in the elderly, infirm and mentally confused who present to the accident department with suspected occult hip fracture.

The Hip and Knee Book: developing an active management booklet for hip and knee osteoarthritis.

BACKGROUND: The pain and disability of hip and knee osteoarthritis can be improved by exercise, but the best method of encouraging this is not known. AIM: To develop an evidence-based booklet for patients with hip or knee osteoarthritis, offering information and advice on maintaining activity. DESIGN OF STUDY: Systematic review of reviews and guidelines, then focus groups. SETTING: Four general practices in North East Wales. METHOD: Evidence-based messages were developed from a systematic review, synthesised into patient-centred messages, and then incorporated into a narrative. A draft booklet was examined by three focus groups to improve the phrasing of its messages and discuss its usefulness. The final draft was examined in a fourth focus group. RESULTS: Six evidence-based guidelines and 54 systematic reviews were identified. The focus groups found the draft booklet to be informative and easy to read. They reported a lack of clarity about the cause of osteoarthritis and were surprised that the pain could improve. The value of exercise and weight loss beliefs was accepted and reinforced, but there was a perceived contradiction about heavy physical work being causative, while moderate exercise was beneficial. There was a fear of dependency on analgesia and misinterpretation of the message on hyaluranon injections. The information on joint replacement empowered patients to discuss referral with their GP. The text was revised to accommodate these issues. CONCLUSION: The booklet was readable, credible, and useful to end-users. A randomised controlled trial is planned, to test whether the booklet influences beliefs about osteoarthritis and exercise.

Activity Increase Despite Arthritis (AIDA): design of a Phase II randomised controlled trial evaluating an active management booklet for hip and knee osteoarthritis [ISRCTN24554946].

BACKGROUND: Hip and knee osteoarthritis is a common cause of pain and disability, which can be improved by exercise interventions. However, regular exercise is uncommon in this group because the low physical activity level in the general population is probably reduced even further by pain related fear of movement. The best method of encouraging increased activity in this patient group is not known. A booklet has been developed for patients with hip or knee osteoarthritis. It focuses on changing disadvantageous beliefs and encouraging increased physical activity. METHODS/DESIGN: This paper describes the design of a Phase II randomised controlled trial (RCT) to test the effectiveness of this new booklet for patients with hip and knee osteoarthritis in influencing illness and treatment beliefs, and to assess the feasibility of conducting a larger definitive RCT in terms of health status and exercise behaviour. A computerised search of four general medical practice patients' record databases will identify patients older than 50 years of age who have consulted with hip or knee pain in the previous twelve months. A random sample of 120 will be invited to participate in the RCT comparing the new booklet with a control booklet, and we expect 100 to return final questionnaires. This trial will assess the feasibility of recruitment and randomisation, the suitability of the control intervention and outcome measurement tools, and will provide an estimate of effect size. Outcomes will include beliefs about hip and knee pain, beliefs about exercise, fear avoidance, level of physical activity, health status and health service costs. They will be measured at baseline, one month and three months. DISCUSSION: We discuss the merits of testing effectiveness in a phase II trial, in terms of intermediate outcome measures, whilst testing the processes for a larger definitive trial. We also discuss the advantages and disadvantages of testing the psychometric properties of the primary outcome measures concurrently with the trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN24554946.

Statin-induced muscular symptoms: a report of 3 cases.

Although the prescription of statin medication has increased worldwide and especially in Europe, its musculoskeletal side effects and their management strategy has not been highlighted in orthopaedic literature. We present three cases of statin-induced musculoskeletal symptoms which presented to an orthopaedic department. There were two patients with statin induced muscle pain (one in the thigh and one around the hip), and one with both myositis (with raised creatine kinase) and lupus-like symptoms. All of the symptoms resolved with stopping the statin. Muscle pain (often with normal creatine kinase) is the commonest side effect of statins. It is usually bilateral, but two of our cases presented with unilateral symptoms which made it more difficult to exclude a primary orthopaedic pathology. The widespread use of statins is likely to lead to an increase in the number of patients presenting to orthopaedic surgeons with muscle pain. It is important to consider muscle pain induced by statins in the differential diagnosis of acute or chronic pain in the limbs.

Treatment and prevention of depression after surgery for hip fracture in older people: randomized, controlled trials.

OBJECTIVES: To evaluate the effect of a psychiatric intervention in treating depression (treatment study) and the effect of a psychological treatment in preventing depression (prevention study) after hip fracture in older people. DESIGN: Two linked randomized, controlled trials. SETTING: Orthopedic units in Manchester, England. PARTICIPANTS: Two hundred ninety-three older people who had undergone surgery for a fractured hip: 121 in the treatment study and 172 in the prevention study. MEASUREMENTS: The Geriatric Depression Scale and Hospital Anxiety and Depression Scale for mood, functional tests for mobility and pain measures. RESULTS: There was a slight reduction in depressive symptoms in the active arm of the treatment study. In the prevention study, there was no significant difference in incident depression between the psychological intervention and treatment as usual. There were no differences in the functional and pain outcomes. CONCLUSION: The results from these two randomized, controlled trials show that, after hip fracture surgery, no statistically significant benefits can be achieved from a psychiatric intervention in people who are depressed or a psychological intervention to prevent the onset of depression.

An externally fixed femoral fracture model for mice.

Transgenic and knockout mouse models can be used to help understand the molecular mechanisms of fracture repair. This study examines the feasibility of applying an external fixator to the mouse femur as one model for studying fracture repair. The external fixator consisted of two aluminum blocks connected by two rods. Four pins are used to connect the blocks to the bone. Mechanical characterization of the fixators was carried out prior to their use. Sixty-two wild type mice with bilateral femoral fractures were created using an open technique and fixed using the fixator. The progress of fracture healing was monitored radiologically before sacrifice and by mechanical testing and histology after sacrifice. Initially four mice died intraoperatively from excessive blood loss, the intraoperative mortality was subsequently reduced by subcutaneous saline infusion. The bone healed between 14 and 21 days after fracture and remodeled by 60 days. Both radiological and mechanical assessments showed a steady progression of bone healing. Histology demonstrated callus and endochondral bone formation. This study demonstrated that it is possible to create a mouse femoral fracture model stabilized by external fixation and will provide an additional model to the understanding of fracture healing in transgenic and knockout mice.

Evidence for cell-specific changes with age in expression of oestrogen receptor (ER) alpha and beta in bone fractures from men and women.

Oestrogen is recognized as important for maintaining bone mass in men and women. Oestrogen receptor (ER) alpha and the recently described ER-beta are both expressed in bone cells, but have different affinities for oestrogen agonists and plant oestrogens, which could be important in developing treatments for bone loss in both men and women. It is unclear, however, which isoform predominates in bone; cell type and age may influence their relative expression. The present study has compared ER-alpha and ER-beta expression in serial sections of human fracture callus from males (n = 19, age range 5-72 years) and females (n = 15, age range 3-86 years) by indirect immunoperoxidase. Fracture callus was used as it can be readily obtained from individuals over a wide age range and contains a variety of bone cells. Antibody specificity was confirmed by western blotting and comparison of immunoreactivity in sections of breast tumour and benign prostate hyperplasia. No gender difference in ER expression was found in bone from individuals less than 40 years old. Proliferative chondrocytes were positive for both isoforms, but few larger hypertrophic cells were immunoreactive. ER-alpha and ER-beta were co-expressed in osteoclasts, suggesting that oestrogen may act directly on these cells. Osteoblasts, osteocytes, and mesenchymal cells also expressed both isoforms. In women over 40 years of age, however, relatively fewer biopsies contained osteocytes positive for ER-alpha and ER-beta. Likewise, the proportions of osteoblasts and mesenchymal cells expressing ER-beta were reduced but ER-alpha remained unaffected. In contrast, in men over 40 years, only the proportion of biopsies containing ER-beta-positive mesenchymal cells was lower. In these older men and women, ER-alpha and ER-beta expression was retained by the small proliferative chondrocytes. These results demonstrate that gender, age, and cell type are important determinants of ER isoform expression in skeletal cells.