Five-year follow-up results of the PROFHER trial comparing operative and non-operative treatment of adults with a displaced fracture of the proximal humerus.

AIMS: The PROximal Fracture of the Humerus Evaluation by Randomisation (PROFHER) randomised clinical trial compared the operative and non-operative treatment of adults with a displaced fracture of the proximal humerus involving the surgical neck. The aim of this study was to determine the long-term treatment effects beyond the two-year follow-up. PATIENTS AND METHODS: Of the original 250 trial participants, 176 consented to extended follow-up and were sent postal questionnaires at three, four and five years after recruitment to the trial. The Oxford Shoulder Score (OSS; the primary outcome), EuroQol 5D-3L (EQ-5D-3L), and any recent shoulder operations and fracture data were collected. Statistical and economic analyses, consistent with those of the main trial were applied. RESULTS: OSS data were available for 164, 155 and 149 participants at three, four and five years, respectively. There were no statistically or clinically significant differences between operative and non-operative treatment at each follow-up point. No participant had secondary shoulder surgery for a new complication. Analyses of EQ-5D-3L data showed no significant between-group differences in quality of life over time. CONCLUSION: These results confirm that the main findings of the PROFHER trial over two years are unchanged at five years. Cite this article: Bone Joint J 2017;99-B:383-92.

Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures.

OBJECTIVES: Accurate characterisation of fractures is essential in fracture management trials. However, this is often hampered by poor inter-observer agreement. This article describes the practicalities of defining the fracture population, based on the Neer classification, within a pragmatic multicentre randomised controlled trial in which surgical treatment was compared with non-surgical treatment in adults with displaced fractures of the proximal humerus involving the surgical neck. METHODS: The trial manual illustrated the Neer classification of proximal humeral fractures. However, in addition to surgical neck displacement, surgeons assessing patient eligibility reported on whether either or both of the tuberosities were involved. Anonymised electronic versions of baseline radiographs were sought for all 250 trial participants. A protocol, data collection tool and training presentation were developed and tested in a pilot study. These were then used in a formal assessment and classification of the trial fractures by two independent senior orthopaedic shoulder trauma surgeons. RESULTS: Two or more baseline radiographic views were obtained for each participant. The independent raters confirmed that all fractures would have been considered for surgery in contemporaneous practice. A full description of the fracture population based on the Neer classification was obtained. The agreement between the categorisation at baseline (tuberosity involvement) and Neer classification as assessed by the two raters was only fair (kappa 0.29). However, this disparity did not appear to affect trial findings, specifically in terms of influencing the effect of treatment on the primary outcome of the trial. CONCLUSIONS: A key reporting requirement, namely the description of the fracture population, was achieved within the context of a pragmatic multicentre randomised clinical trial. This article provides important guidance for researchers designing similar trials on fracture management.Cite this article: H. H. G. Handoll, S. D. Brealey, L. Jefferson, A. Keding, A. J. Brooksbank, A. J. Johnstone, J. J. Candal-Couto, A. Rangan. Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures.Bone Joint Res 2016;5:481-489. DOI: 10.1302/2046-3758.510.BJR-2016-0132.R1.

Developing, delivering and documenting rehabilitation in a multi-centre randomised controlled surgical trial: experiences from the ProFHER trial.

OBJECTIVES: A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults. METHODS: These processes included the development of a patient information leaflet on self-care during sling immobilisation, the development of a basic treatment physiotherapy protocol that received input and endorsement by specialist physiotherapists providing patient care, and establishing an expectation for the provision of home exercises. Specially designed forms were also developed to facilitate reliable reporting of the physiotherapy care that patients received. RESULTS: All three initiatives were successfully implemented, alongside the measures to optimise the documentation of physiotherapy. Thus, all participating sites that recruited patients provided the sling immobilisation leaflet, all adhered to the physiotherapy protocol and all provided home exercises. There was exemplary completion of the physiotherapy forms that often reflected a complex patient care pathway. These data demonstrated equal and high access to and implementation of physiotherapy between groups, including the performance of home exercises. CONCLUSION: In order to increase the validity and relevance of the evidence from trials of surgical interventions and meet international reporting standards, careful attention to study design, conduct and reporting of the intrinsic rehabilitation components is required. The involvement of rehabilitation specialists is crucial to achieving this. Cite this article: Bone Joint Res 2014;3:335-40.

Interventions for treating wrist fractures in children.

BACKGROUND: Approximately a third of all fractures in children occur at the wrist, usually from falling onto an outstretched hand. OBJECTIVES: We aimed to evaluate removable splintage versus plaster casts (requiring removal by a specialist) for undisplaced compression (buckle) fractures; cast length and position; and the role of surgical fixation for displaced wrist fractures in children. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (October 2007), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2007, Issue 4), MEDLINE (from 1966), EMBASE (from 1988), CINAHL (from 1982) and reference lists of articles. Date of last search October 2007. SELECTION CRITERIA: Any randomised or quasi-randomised controlled trials comparing types and position of casts and the use of surgical fixation for distal radius fractures in children. DATA COLLECTION AND ANALYSIS: Two authors performed trial selection. All three authors independently assessed methodological quality and extracted data. MAIN RESULTS: The 10 included trials, involving 827 children, were of variable quality.Four trials compared removable splintage versus the traditional below-elbow cast in children with buckle fractures. There was no short-term deformity recorded in all four trials and, in one trial, no refracture at six months. The Futura splint was cheaper to use; a removable plaster splint was less restrictive to wear enabling more children to bathe and participate in other activities, and the option preferred by children and parents; the soft bandage was more comfortable, convenient and less painful to wear; home-removable plaster casts removed by parents did not result in significant differences in outcome but were strongly favoured by parents. Two trials found below-elbow versus above-elbow casts did not increase redisplacement of reduced fractures or cast-related complications, were less restrictive during use and avoided elbow stiffness. One trial evaluating the effect of arm position in above-elbow casts found no effect on deformity. Three trials found that percutaneous wiring significantly reduced redisplacement and remanipulation but one of these found no advantage in function at three months. AUTHORS' CONCLUSIONS: Limited evidence supports the use of removable splintage for buckle fractures and challenges the traditional use of above-elbow casts after reduction of displaced fractures. Although percutaneous wire fixation prevents redisplacement, the effects on longer term outcomes including function are not established. Further research is warranted on the optimum approach, including splintage, for buckle fractures; and on the use of below-elbow casts and indications for surgery for displaced wrist fractures in children.

Bone grafts and bone substitutes for treating distal radial fractures in adults.

BACKGROUND: Surgical treatment of fractures of the distal radius can involve the implantation of bone scaffolding materials (bone grafts and substitutes) into bony defects that frequently arise after fracture reduction. OBJECTIVES: To review the evidence from randomised controlled trials evaluating the implanting of bone scaffolding materials for treating distal radial fractures in adults. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (June 2007), the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and other databases, conference proceedings and reference lists. No language restrictions were applied. SELECTION CRITERIA: Randomised or quasi-randomised controlled clinical trials evaluating the use of bone scaffolding for treating distal radial fracture in adults. DATA COLLECTION AND ANALYSIS: Two people independently selected studies and undertook assessment and data collection. MAIN RESULTS: Ten heterogenous trials involving 874 adults with generally unstable fractures were grouped into six comparisons. No trial had proven allocation concealment. Four trials (239 participants) found implantation of bone scaffolding (autogenous bone graft (one trial); Norian SRS - a bone substitute (two trials); methylmethacrylate cement (one trial)) improved anatomical outcomes compared with plaster cast alone; and two found it improved function. Reported complications of bone scaffolding were transient discomfort resulting from extraosseous deposits of Norian SRS; with surgical removal of one intra-articular deposit. One trial (323 participants) comparing bone substitute (Norian SRS) versus plaster cast or external fixation found no difference in functional or anatomical outcomes at one year. Statistically significant complications in the respective groups were extraosseous Norian SRS deposits and pin track infection. One trial (48 participants with external fixation) found that autogenous bone graft did not significantly change outcome. There was one serious donor-site complication. One trial (21 participants) found some indication of worse outcomes for hydroxyapatite bone cement compared with Kapandji's intrafocal pinning. Three trials (180 participants) found bone scaffolding (autogenous bone graft (one trial); Norian SRS (one trial); methylmethacrylate cement (one trial)) gave no significant difference in functional outcomes but some indication of better anatomical outcomes compared with external fixation. Most reported complications were associated with external fixation; extraosseous deposits of Norian SRS occurred in one trial. One trial (93 participants with dorsal plate fixation) found autografts slightly improved wrist function compared with allogenic bone material but with an excess of donor site complications. AUTHORS' CONCLUSIONS: Bone scaffolding may improve anatomical outcome compared with plaster cast alone but there is insufficient evidence to conclude on functional outcome and safety; or for other comparisons.

Different methods of external fixation for treating distal radial fractures in adults.

BACKGROUND: Fracture of the distal radius is a common injury. A surgical treatment is external fixation, where metal pins inserted into bone on either side of the fracture are then fixed to an external frame. OBJECTIVES: To evaluate the evidence from randomised controlled trials comparing different methods of external fixation for distal radial fractures in adults. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (June 2007), the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and other databases, conference proceedings and reference lists of articles. No language restrictions were applied. SELECTION CRITERIA: Randomised or quasi-randomised controlled clinical trials which compared different methods of external fixation in adults with a distal radial fracture. DATA COLLECTION AND ANALYSIS: All review authors independently performed study selection. Two authors independently assessed the included trials and performed data extraction. MAIN RESULTS: Nine small trials involving 510 adults with potentially or evidently unstable fractures, were grouped into five comparisons. The interventional, clinical and methodological heterogeneity of trials precluded data pooling. Only one trial had secure allocation concealment. Two trials comparing a bridging (of the wrist) external fixator versus pins and plaster external fixation found no significant differences in function or deformity. One trial found tendencies for more serious complications but less subsequent discomfort and deformity in the fixator group. Three trials compared non-bridging versus bridging fixation. Of the two trials testing uni-planar non-bridging fixation, one found no significant differences in functional or clinical outcomes; the other found non-bridging fixation significantly improved grip strength, wrist flexion and anatomical outcome. The third trial found no significant findings in favour of multi-planar non-bridging fixation of complex intra-articular fractures. One trial using a bridging external fixator found that deploying an extra external fixator pin to fix the 'floating' distal fragment gave superior functional and anatomical results. One trial found no evidence of differences in clinical outcomes for hydroxyapatite coated pins compared with standard uncoated pins. Two trials compared dynamic versus static external fixation. One trial found no significant effects from early dynamism of an external fixator. The poor quality of the other trial undermines its findings of poorer functional and anatomical outcomes for dynamic fixation. AUTHORS' CONCLUSIONS: There is insufficient robust evidence to determine the relative effects of different methods of external fixation. Adequately powered studies could provide better evidence.

WITHDRAWN: Physiotherapist-led programmes and interventions for rehabilitation of anterior cruciate ligament, medial collateral ligament and meniscal injuries of the knee in adults.

BACKGROUND: Soft-tissue injuries of the knee, mainly involving the anterior cruciate ligament (ACL), the medial collateral ligament (MCL) and menisci, are common and their rehabilitation after non-surgical or surgical treatment often involves intensive and prolonged physiotherapy. OBJECTIVES: To examine the evidence for effectiveness of various physiotherapist-led (or 'directed') rehabilitation programmes, and of various interventions used within these programmes, for rehabilitation of acute or chronic ACL, MCL or meniscal injuries of the knee in adults. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group's specialised register (to June 2001), MEDLINE (from 1966 to August 1999), EMBASE (from 1980 to February 1997), CINAHL (1982 to April 1999), CURRENT CONTENTS (up to March 1999) and reference lists of relevant articles, and consulted colleagues. Date of the most recent search: June 2001. SELECTION CRITERIA: Randomised or quasi-randomised clinical trials evaluating physiotherapist-led rehabilitation programmes, or components of rehabilitation programmes, for the treatment or post-surgical rehabilitation of ACL, MCL or knee meniscal injuries. Excluded were trials investigating electrical stimulation, or various interventions such as cryotherapy, immobilisation braces and continuous passive motion when used in initial or early treatment. Laboratory based trials reporting intermediate outcomes were also excluded. DATA COLLECTION AND ANALYSIS: All trials, judged as fitting the selection criteria by two reviewers, were independently assessed by two reviewers for methodological quality by use of an 11 item checklist. Data were independently extracted by two reviewers. Any disagreement was resolved by discussion. Although quantitative data from most trials are presented, using relative risks or mean differences together with 95 per cent confidence intervals, trial heterogeneity and lack of outcome data prevented meaningful pooling of results from comparable trials. MAIN RESULTS: Thirty-one trials, involving 1545 mainly young and male patients, met the inclusion criteria of the review. Methodological quality was highly variable: allocation concealment and / or assessor blinding were rare, and assessment of outcome was often incomplete and short-term. ACL injury and /or deficiency was the main focus of 18 trials, MCL injury of two trials, meniscal injury of nine trials and a mixture of soft-tissue injuries in the other two trials. The trial comparisons fell into five main categories: rehabilitation programme versus control (6 trials); one rehabilitation programme versus another (6 trials); different timing of rehabilitation (4 trials); one component of a programme versus another (6 trials); supplementary interventions to a programme versus none (9 trials). No trial provided sufficient evidence to establish the relative effectiveness of the intervention(s) under investigation. AUTHORS' CONCLUSIONS: The available evidence for physiotherapist-led rehabilitation of ACL, MCL and meniscal injuries is wide ranging in terms of scope but insufficient to establish the relative effectiveness of the various approaches and methods in current use. There is a need for further research involving good quality, large scale randomised trials with sufficiently long follow-up to fully assess knee function and recovery.

Percutaneous pinning for treating distal radial fractures in adults.

BACKGROUND: Fracture of the distal radius is a common clinical problem. A key method of surgical fixation is percutaneous pinning, involving the insertion of wires through the skin to stabilise the fracture. OBJECTIVES: To evaluate the evidence from randomised controlled trials for the use of percutaneous pinning for fractures of the distal radius in adults. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (September 2006), the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and other databases, conference proceedings and reference lists of articles. No language restrictions were applied. SELECTION CRITERIA: Randomised or quasi-randomised controlled clinical trials involving adults with a fracture of the distal radius, which compared percutaneous pinning with conservative treatment, or different aspects of percutaneous pinning. DATA COLLECTION AND ANALYSIS: Two authors independently assessed and extracted data from the included trials. Some pooling of data was undertaken for one comparison. MAIN RESULTS: Thirteen trials, involving 940 generally older adults with dorsally displaced and potentially or evidently unstable distal radial fractures, were included. Methodological weaknesses among these trials included lack of allocation concealment and inadequate outcome assessment. Factors affecting the applicability of trial evidence included inconsistent fracture classification, variations in outcome assessment and incomplete reporting. Six heterogeneous trials compared percutaneous pinning with plaster cast immobilisation. Across-fracture pinning, used in five trials, was associated with improved anatomical outcome and generally minor complications. There was some indication of similar or improved function in the pinning group. One quasi-randomised trial found an excess of complications after Kapandji pinning. Three trials compared different methods of pinning. Two trials found a higher incidence of complications after Kapandji fixation compared with two methods of across-fracture fixation. The third trial provided inadequate evidence for modified Kapandji fixation versus Willenegger fixation. Two small trials comparing biodegradable pins versus metal pins found a significant excess of complications associated with biodegradable material. Two small trials compared plaster cast immobilisation for one week versus for six weeks after surgery. One trial found duration of immobilisation after trans-styloid fixation did not have a significant effect on outcome. More complications occurred in the early mobilisation group after Kapandji pinning in the second trial. AUTHORS' CONCLUSIONS: Though there is some evidence to support its use, the precise role and methods of percutaneous pinning are not established. The higher rates of complications with Kapandji pinning and biodegradable materials casts some doubt on their general use.

External fixation versus conservative treatment for distal radial fractures in adults.

BACKGROUND: Fracture of the distal radius ('broken wrist') is a common clinical problem. It can be treated conservatively, usually involving wrist immobilisation in a plaster cast, or surgically. A key method of surgical fixation is external fixation. OBJECTIVES: To evaluate the evidence from randomised controlled trials comparing external fixation with conservative treatment for fractures of the distal radius in adults. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (September 2006), the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and other databases, conference proceedings and reference lists of articles. No language restrictions were applied. SELECTION CRITERIA: Randomised or quasi-randomised controlled clinical trials involving adults with a fracture of the distal radius, which compared external fixation with conservative treatment. DATA COLLECTION AND ANALYSIS: After independent study selection by all review authors, two authors independently assessed the included trials. Independent data extraction of new trials was performed by two authors. Pooling of data was undertaken where appropriate. MAIN RESULTS: Fifteen heterogeneous trials, involving 1022 adults with dorsally displaced and potentially or evidently unstable distal radial fractures, were included. While all trials compared external fixation versus plaster cast immobilisation, there was considerable variation especially in terms of patient characteristics and interventions. Methodological weaknesses among these trials included lack of allocation concealment and inadequate outcome assessment. External fixation maintained reduced fracture positions (redisplacement requiring secondary treatment: 7/356 versus 51/338 (data from 9 trials); relative risk 0.17, 95% confidence interval 0.09 to 0.32) and prevented late collapse and malunion compared with plaster cast immobilisation. There was insufficient evidence to confirm a superior overall functional or clinical result for the external fixation group. External fixation was associated with a high number of complications, such as pin-track infection, but many of these were minor. Probably, some complications could have been avoided using a different surgical technique for pin insertion. There was insufficient evidence to establish a difference between the two groups in serious complications such as reflex sympathetic dystropy: 25/384 versus 17/347 (data from 11 trials); relative risk 1.31, 95% confidence interval 0.74 to 2.32. AUTHORS' CONCLUSIONS: There is some evidence to support the use of external fixation for dorsally displaced fractures of the distal radius in adults. Though there is insufficient evidence to confirm a better functional outcome, external fixation reduces redisplacement, gives improved anatomical results and most of the excess surgically-related complications are minor.

Surgical versus conservative treatment for acute injuries of the lateral ligament complex of the ankle in adults.

BACKGROUND: Ankle sprains are one of the most commonly treated musculoskeletal injuries. The three main treatment modalities for acute lateral ankle ligament injuries are immobilisation with plaster cast or splint, 'functional treatment' comprising early mobilisation and use of an external support (e.g. ankle brace), and surgical repair or reconstruction. OBJECTIVES: We aimed to compare surgical versus conservative treatment for acute injuries of the lateral ligament complex of the ankle in adults. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (January 2006), the Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2005, Issue 4), MEDLINE (1966 to December 2005), EMBASE, CINAHL and reference lists of articles, and contacted researchers in the field. This review is considered updated to January 2006. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing surgical with conservative interventions for treating ankle sprains in adults. DATA COLLECTION AND ANALYSIS: At least two authors independently assessed methodological quality and extracted data. Where appropriate, results of comparable studies were pooled. We performed sensitivity analyses to explore the robustness of the findings. MAIN RESULTS: Twenty trials were included. These involved a total of 2562 mostly young active adult males. All trials had methodological weaknesses. Specifically, concealment of allocation was confirmed in only one trial. Data for pooling individual outcomes were only available for a maximum of 12 trials and under 60% of participants. The findings of statistically significant differences in favour of the surgical treatment group for the four primary outcomes (non-return to pre-injury level of sports; ankle sprain recurrence; long-term pain; subjective or functional instability) when using the fixed-effect model were not robust when using the random-effects model, nor on the removal of one low quality (quasi-randomised) trial that had more extreme results. A corresponding drop in the I(2) statistics showed the remaining trials to be more homogeneous. The functional implications of the statistically significantly higher incidence of objective instability in conservatively treated trial participants are uncertain. There was some limited evidence for longer recovery times, and higher incidences of ankle stiffness, impaired ankle mobility and complications in the surgical treatment group. AUTHORS' CONCLUSIONS: There is insufficient evidence available from randomised controlled trials to determine the relative effectiveness of surgical and conservative treatment for acute injuries of the lateral ligament complex of the ankle. High quality randomised controlled trials of primary surgical repair versus the best available conservative treatment for well-defined injuries are required.

Mobilisation strategies after hip fracture surgery in adults.

BACKGROUND: Hip fracture mainly occurs in older people. Mobilisation strategies such as gait retraining and exercises are used at various stages of rehabilitation after surgery. OBJECTIVES: To evaluate the effects of different mobilisation strategies after hip fracture surgery in adults. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE and other databases, conference proceedings and reference lists of articles, up to January 2006. SELECTION CRITERIA: All randomised or quasi-randomised trials comparing different mobilisation strategies after hip fracture surgery. DATA COLLECTION AND ANALYSIS: The authors independently selected trials, assessed trial quality and extracted data. There was no data pooling. MAIN RESULTS: Most of the 13 included trials (involving 1065 participants, generally over 65 years) were small and all had methodological limitations, including inadequate follow up. Seven trials evaluated mobilisation strategies started soon after hip fracture surgery. One historic trial found no significant differences in unfavourable outcomes for weight bearing started at two versus 12 weeks after internal fixation of a displaced intracapsular fracture. Two trials compared a more with a less intensive regimen of physiotherapy: one found no difference in recovery, the other found a higher level of drop-out in the more intensive group with no difference in length of hospital stay. One trial found short-term improvement in mobility and balance for a two-week programme of weight-bearing versus non-weight-bearing exercise. One trial found improved mobility in those given a quadriceps muscle strengthening exercise programme. One trial found no significant difference in recovery of mobility after a treadmill versus conventional gait retraining programme. One trial found a greater recovery of pre-fracture mobility after neuromuscular stimulation of the quadriceps muscle. Six trials evaluated strategies started after hospital discharge. Started soon after discharge, two trials found improved outcome after 12 weeks of intensive physical training and a home-based physical therapy programme respectively. Begun after completion of standard physical therapy, one trial found improved outcome after six months of intensive physical training whereas another trial found no significant effects of home-based resistance or aerobic training. One trial found improved outcome after home-based exercises started around 22 weeks from injury. One trial found home-based weight-bearing exercises starting at seven months produced no statistically significant differences aside for greater quadriceps strength. AUTHORS' CONCLUSIONS: There is insufficient evidence from randomised trials to establish the effectiveness of the various mobilisation strategies used in rehabilitation after hip fracture surgery. Further research is required to establish the possible benefits of the additional provision of interventions, including intensive supervised exercises, primarily aimed at enhancing mobility.

Nutritional supplementation for hip fracture aftercare in older people.

BACKGROUND: Older people with hip fractures are often malnourished at the time of fracture, and have poor food intake subsequently. OBJECTIVES: To review the effects of nutritional interventions in older people recovering from hip fracture. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (December 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2006, Issue 1), MEDLINE, six other databases and reference lists. We contacted investigators and handsearched journals. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials of nutritional interventions for people aged over 65 years with hip fracture. DATA COLLECTION AND ANALYSIS: Both authors independently selected trials, extracted data and assessed trial quality. We sought additional information from trialists, and pooled data for primary outcomes. MAIN RESULTS: Twenty-one randomised trials involving 1727 participants were included. Overall trial quality was poor, specifically regarding allocation concealment, assessor blinding and intention-to-treat analysis, and limited availability of outcome data. Eight trials evaluated oral multinutrient feeds: providing non-protein energy, protein, some vitamins and minerals. Oral feeds had no statistically significant effect on mortality (15/161 versus 17/176; relative risk (RR) 0.89, 95% confidence interval (CI) 0.47 to 1.68) but may reduce 'unfavourable outcome' (combined outcome of mortality and survivors with medical complications) (14/66 versus 26/73; RR 0.52, 95% CI 0.32 to 0.84). Four trials examining nasogastric multinutrient feeding showed no evidence of an effect on mortality (RR 0.99, 95% CI 0.50 to 1.97) but the studies were heterogeneous regarding case mix. Nasogastric feeding was poorly tolerated. There was insufficient information for other outcomes. Increasing protein intake in an oral feed was tested in four trials. There was no evidence for an effect on mortality (RR 1.42, 95% CI 0.85 to 2.37). Protein supplementation may have reduced the number of long term medical complications. Two trials, testing intravenous vitamin B1 and other water soluble vitamins, or 1-alpha-hydroxycholecalciferol (an active form of vitamin D) respectively, produced no evidence of effect for either supplement. One trial, evaluating dietetic assistants to help with feeding, showed a trend for a reduction in mortality (RR 0.57, 99% CI 0.29 to 1.11). AUTHORS' CONCLUSIONS: Some evidence exists for the effectiveness of oral protein and energy feeds, but overall the evidence for the effectiveness of nutritional supplementation remains weak. Adequately sized trials are required which overcome the methodological defects of the reviewed studies. In particular, the role of dietetic assistants requires further evaluation.

Pre-operative traction for fractures of the proximal femur in adults.

BACKGROUND: Following a hip fracture, traction may be applied to the injured limb before surgery. OBJECTIVES: To evaluate the effects of traction applied to the injured limb prior to surgery for a fractured hip. Different methods of applying traction (skin or skeletal) were considered. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (March 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2006), MEDLINE (1966 to March 2006), EMBASE (1988 to 2006 Week 11), CINAHL (1982 to March 2006), the UK National Research Register (Issue 1, 2006), conference proceedings and reference lists of articles. SELECTION CRITERIA: All randomised or quasi-randomised trials comparing either skin or skeletal traction with no traction, or skin with skeletal traction for patients with an acute hip fracture prior to surgery. DATA COLLECTION AND ANALYSIS: Both authors independently assessed trial quality and extracted data. Additional information was sought from all trialists. Wherever appropriate and possible, data were pooled. MAIN RESULTS: Ten randomised trials, mainly of moderate quality, involving a total of 1546 predominantly elderly patients with hip fractures, were identified and included in the review. Nine trials compared traction with no traction. Although limited data pooling was possible, overall this provided no evidence of benefit from traction, either in the relief of pain before surgery or ease of fracture reduction or quality of fracture reduction at time of surgery. One of these trials included both skin and skeletal traction groups. This trial and one other compared skeletal traction with skin traction and found no important differences between these two methods, although the initial application of skeletal traction was noted as being more painful and more costly. AUTHORS' CONCLUSIONS: From the evidence available, the routine use of traction (either skin or skeletal) prior to surgery for a hip fracture does not appear to have any benefit. However, the evidence is also insufficient to rule out the potential advantages for traction, in particular for specific fracture types, or to confirm additional complications due to traction use. Further, high quality trials would be required to confirm or refute the absence of benefits of traction.

Rehabilitation for distal radial fractures in adults.

BACKGROUND: Fracture of the distal radius is a common clinical problem, particularly in older white women with osteoporosis. OBJECTIVES: To examine the effects of rehabilitation interventions in adults with conservatively or surgically treated distal radial fractures. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (December 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4, 2005), MEDLINE, EMBASE, CINAHL, AMED, PEDro, OTseeker and other databases, conference proceedings and reference lists of articles. No language restrictions were applied. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials evaluating rehabilitation as part of the management of fractures of the distal radius sustained by adults. Rehabilitation interventions such as active and passive mobilisation exercises, and training for activities of daily living, could be used on their own or in combination, and be applied in various ways by various clinicians. DATA COLLECTION AND ANALYSIS: The authors independently selected and reviewed trials. Study authors were contacted for additional information. No data pooling was done. MAIN RESULTS: Fifteen trials, involving 746 mainly female and older patients, were included. Initial treatment was conservative, involving plaster cast immobilisation, in all but 27 participants whose fractures were fixed surgically. Though some trials were well conducted, others were methodologically compromised. For interventions started during immobilisation, there was weak evidence of improved hand function for hand therapy in the days after plaster cast removal, with some beneficial effects continuing one month later (one trial). There was weak evidence of improved hand function in the short term, but not in the longer term (three months), for early occupational therapy (one trial), and of a lack of differences in outcome between supervised and unsupervised exercises (one trial). For interventions started post-immobilisation, there was weak evidence of a lack of clinically significant differences in outcome in patients receiving formal rehabilitation therapy (four trials), passive mobilisation (two trials), ice or pulsed electromagnetic field (one trial), or whirlpool immersion (one trial) compared with no intervention. There was weak evidence of a short-term benefit of continuous passive motion (post external fixation) (one trial), intermittent pneumatic compression (one trial) and ultrasound (one trial). There was weak evidence of better short-term hand function in participants given physiotherapy than in those given instructions for home exercises by a surgeon (one trial). AUTHORS' CONCLUSIONS: The available evidence from randomised controlled trials is insufficient to establish the relative effectiveness of the various interventions used in the rehabilitation of adults with fractures of the distal radius.

Intramedullary nails for extracapsular hip fractures in adults.

BACKGROUND: Intramedullary nails may be used for the surgical fixation of extracapsular hip fractures in adults. They may be inserted from the top (cephalocondylic) or from the bottom (condylocephalic) end of the femur. OBJECTIVES: To compare different types or design modifications of intramedullary nails used in the fixation of extracapsular hip fractures. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (March 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2006), MEDLINE, EMBASE, the UK National Research Register, several orthopaedic journals, conference proceedings and reference lists of articles. SELECTION CRITERIA: All randomised or quasi-randomised trials comparing different types of intramedullary nails or modifications to the design of intramedullary nails in the treatment of extracapsular hip fractures in adults. DATA COLLECTION AND ANALYSIS: Both authors independently assessed trial quality and extracted data. Additional information was sought from all trialists. MAIN RESULTS: Six studies, involving a total of 1071 predominantly female and older people with mainly unstable trochanteric fractures, were included. Allocation concealment was likely in one trial, not described in three and not done in the other two trials. Four studies, with 910 participants, compared the proximal femoral nail with the Gamma nail. Though there was increased risk of comminution (fragmentation) at the fracture site when inserting a Gamma nail, there was no statistically significant difference in operative fracture of the femur (1/455 versus 5/455; relative risk 0.33, 95% confidence interval 0.07 to 1.63). No notable differences were seen between implants for fracture healing complications, reoperations and other post-operative complications. Pooled data showed no significant difference between implants for mortality (relative risk 1.08, 95% confidence interval 0.82 to 1.41) or function assessment outcomes. One study, with 80 participants, found no differences between a gliding nail versus a standard Gamma nail. Another study, with 81 participants, found no difference between a dynamically versus a statically locked intramedullary hip screw. AUTHORS' CONCLUSIONS: The limited evidence from the randomised trials undertaken to date is insufficient to determine whether there are important differences in outcome between different designs of intramedullary nails used in the internal fixation of extracapsular hip fractures. Given the evidence of superiority of the sliding hip screw compared with intramedullary nails for extracapsular hip fractures, further studies comparing different designs of intramedullary nails are not a priority. Any new design should be evaluated in a randomised comparison with the sliding hip screw.

Replacement arthroplasty versus internal fixation for extracapsular hip fractures in adults.

BACKGROUND: Internal fixation, commonly used for extracapsular hip fractures, may fail particularly in unstable fractures. Replacement of the hip using arthroplasty, often used for intracapsular fractures, has been used as an alternative. OBJECTIVES: To compare replacement arthroplasty with internal fixation for the treatment of extracapsular hip fractures in adults. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (December 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4, 2005), MEDLINE, EMBASE, the UK National Research Register, several orthopaedic journals, conference proceedings and reference lists of articles. SELECTION CRITERIA: Randomised and quasi-randomised trials comparing replacement arthroplasty with an internal fixation implant for adults with an extracapsular hip fracture. DATA COLLECTION AND ANALYSIS: Both review authors independently assessed 10 aspects of trial quality and extracted data. We requested additional information from trial investigators. Where appropriate, limited pooling of data was performed. MAIN RESULTS: Two randomised controlled trials including a total of 148 people aged 70 years or over with unstable extracapsular hip fractures in the trochanteric region were identified and included in this review. Both had methodological limitations, including inadequate assessment of longer-term outcome. One trial compared a cemented arthroplasty with a sliding hip screw. This found no significant differences between the two methods of treatment for operating time, local wound complications, mechanical complications, reoperation, mortality or loss of independence of previously independent patients at one year. There was, however, a higher blood transfusion need in the arthroplasty group. The other trial compared a cementless arthroplasty versus a proximal femoral nail. It also found a higher blood transfusion need in the arthroplasty group, together with a greater operative blood loss, and a longer length of surgery. There were no significant differences between the two interventions for mechanical complications, local wound complications, reoperation, general complications, mortality at one year or long-term function. None of the pooled outcome data yielded statistically significant differences between the arthroplasty and internal fixation, with the exception of the significantly higher numbers of participants in the arthroplasty group requiring blood transfusion (relative risk 1.71, 95% confidence interval 1.05 to 2.77). AUTHORS' CONCLUSIONS: There is insufficient evidence from randomised trials to determine whether replacement arthroplasty has any advantage over internal fixation for extracapsular hip fractures. Further larger well-designed randomised trials comparing arthroplasty versus internal fixation for the treatment of unstable fractures are required.

Extramedullary fixation implants and external fixators for extracapsular hip fractures in adults.

BACKGROUND: Extramedullary fixation of hip fractures involves the application of a plate and screws to the lateral side of the proximal femur. In external fixators, the stabilising component is held outside the thigh by pins or screws driven into the bone. OBJECTIVES: To compare different types of extramedullary fixation implants and external fixators for fixing extracapsular hip fracture in adults. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (July 2005), various other databases, conference proceedings and reference lists. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing extramedullary implants or external fixators for fixing extracapsular hip fracture in adults. DATA COLLECTION AND ANALYSIS: Two authors independently selected trials, assessed trial quality and extracted data. Data were pooled where appropriate. MAIN RESULTS: The 14 included trials tested seven comparisons in a total of 2222 mainly female and older participants. All trials had methodological flaws that may affect the validity of their results. Three trials comparing a fixed nail plate (Jewett or McLaughlin) with the sliding hip screw (SHS) found an increased risk of fixation failure for fixed nail plates. The two trials comparing the Resistance Augmented Bateaux (RAB) plate with the SHS had contrasting results, notably in terms of operative complications, fixation failure and anatomical restoration. One trial comparing the Pugh nail and the SHS found no significant difference between implants. Two trials compared the Medoff plate with the SHS. One trial reported higher blood losses and longer operation times for the Medoff plate. There was a lower risk of fixation failure with the Medoff plate for unstable trochanteric fractures. Two trials compared the Medoff plate with three different screw-plate systems. There were no statistically significant differences in outcome for trochanteric fractures. For subtrochanteric fractures, there was a lower fixation failure rate for the Medoff plate, but no evidence for differences in longer-term outcomes. Two trials comparing the Gotfried percutaneous plate with a SHS found a reduced blood loss with the Gotfried plate. A higher intra-operative fixation failure rate of the Gotfried plate may indicate some restriction to its use. Two trials found less operative trauma for external fixation when compared with the SHS. Final outcome appeared similar. AUTHORS' CONCLUSIONS: The markedly increased fixation failure rate of fixed nail plates compared with the SHS is a major consideration and thus the SHS appears preferable. There was insufficient evidence from other comparisons to draw definite conclusions.

Single, double or multiple injection techniques for axillary brachial plexus block for hand, wrist or forearm surgery.

BACKGROUND: Regional anaesthesia comprising axillary block of the brachial plexus is a common anaesthetic technique for distal upper extremity surgery. OBJECTIVES: To compare the relative effects of anaesthetic techniques using either single, double or multiple injections for axillary block of the brachial plexus for distal upper extremity surgery. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, as well as reference lists of trials. We contacted trial authors and the medical industry. Date of last search: August 2004. SELECTION CRITERIA: We included randomized controlled trials that compared double with single injection techniques, multiple with single injection techniques, or multiple with double injection techniques for axillary block in adults undergoing surgery of the distal upper extremity. DATA COLLECTION AND ANALYSIS: We performed independent study selection, quality assessment and data extraction. We undertook meta-analysis, including exploratory analyses according to the method of nerve location and definition of primary anaesthesia failure. MAIN RESULTS: The 12 included trials involved a total of 981 participants who received regional anaesthesia for hand, wrist, forearm or elbow surgery. Trial design and conduct was generally adequate although several trials failed to monitor longer-term effects and to provide sufficient description of their study populations. Substantial heterogeneity precluded the pooling of data for primary anaesthesia failure from the five trials comparing double versus single injections. However, double injections were significantly more effective than single injections in the three trials where electrolocation was used throughout (relative risk (RR) 0.31, 95% confidence interval (CI) 0.31 to 0.74). Five trials compared multiple with single injections. These showed a statistically significant decrease in primary anaesthesia failure (RR 0.24, 95% CI 0.13 to 0.46) and incomplete motor block (RR 0.61, 95% CI 0.39 to 0.96) in the multiple injection group. Six trials compared multiple with double injections. These showed a statistically significant decrease in primary anaesthesia failure (RR 0.23, 95% CI 0.14 to 0.38) and incomplete motor block (RR 0.55, 95% CI 0.36 to 0.85) in the multiple injection group.Generally, none of the differences between the two groups of any of the three comparisons in secondary analgesia failure, complications and patient discomfort were statistically significant. The time for block performance was significantly shorter for single and double injections compared with multiple injections, but the requirement for supplementary blocks in these groups tended to increase the time to readiness for surgery. AUTHORS' CONCLUSIONS: This review provided some evidence that multiple injection techniques using nerve stimulation for axillary plexus block provide more effective anaesthesia than either double or single injection techniques. However, there was insufficient evidence for other outcomes, including safety.

Conservative management following closed reduction of traumatic anterior dislocation of the shoulder.

BACKGROUND: Acute anterior dislocation is the commonest type of shoulder dislocation and usually results from an injury. Subsequently, the shoulder is less stable and more susceptible to redislocation, especially in active young adults. OBJECTIVES: To compare methods of conservative (non-surgical) management versus no treatment or different methods of conservative management after closed reduction of traumatic anterior dislocation of the shoulder. Interventions include methods of postreduction immobilisation and rehabilitation. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (March 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2005), MEDLINE, EMBASE, the National Research Register (UK), conference proceedings and reference lists of articles. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing various conservative interventions versus control (no or sham treatment) or other conservative interventions applied after closed reduction of traumatic anterior dislocation of the shoulder. DATA COLLECTION AND ANALYSIS: All authors selected trials, assessed methodological quality and extracted data. Study authors were contacted for additional information. MAIN RESULTS: One flawed quasi-randomised trial was included. A "preliminary report" gave the results for 40 adults with primary traumatic anterior dislocation of the shoulder treated by post-reduction immobilisation with the arm in either external or internal rotation. There was no statistically significant difference between the two groups in the failure to return to pre-injury sports by previously active athletes, in redislocation or shoulder instability. Similar numbers of participants of the two groups removed their immobiliser before one week had passed. AUTHORS' CONCLUSIONS: There is a lack of evidence from randomised controlled trials to inform the choices for conservative management following closed reduction of traumatic anterior dislocation of the shoulder. Sufficiently powered, good quality, well reported randomised controlled trials with long-term surveillance of conservative management are required. In particular, trials examining the type and duration of immobilisation would be useful.

Gamma and other cephalocondylic intramedullary nails versus extramedullary implants for extracapsular hip fractures in adults.

BACKGROUND: Two types of implants used for the surgical fixation of extracapsular hip fractures are cephalocondylic intramedullary nails, which are inserted into the femoral canal proximally to distally across the fracture, and extramedullary implants. OBJECTIVES: To compare cephalocondylic intramedullary nails with extramedullary implants (e.g. the sliding hip screw) for extracapsular hip fractures in adults. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (June 2005), the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, the UK National Research Register, orthopaedic journals, conference proceedings and reference lists of articles. SELECTION CRITERIA: All randomised and quasi-randomised controlled trials comparing cephalocondylic nails with extramedullary implants for extracapsular hip fractures. DATA COLLECTION AND ANALYSIS: Both authors independently assessed trial quality and extracted data. Wherever appropriate, results were pooled. MAIN RESULTS: Predominantly older people with mainly trochanteric fractures were treated in the 32 included trials. Twenty trials, involving 3646 people, compared the Gamma nail with the sliding hip screw (SHS). The Gamma nail was associated with an increased risk of operative and later fracture of the femur and an increased reoperation rate. There were no major differences between implants in the wound infection, mortality or medical complications. Data were inadequate for other outcomes. Five trials, involving 623 people, compared the intramedullary hip screw (IMHS) with the SHS. Fracture fixation complications were more common in the IMHS group: all cases of operative and later fracture of the femur occurred in this group. Results for post-operative complications, mortality and functional outcomes were similar in the two groups. Two trials involving 314 people showed no difference in fracture fixation complications, reoperation, wound infection and length of hospital stay for proximal femoral nail (PFN) compared with the SHS. Single trial comparisons (experimental mini-invasive static intramedullary nail compared with the SHS: 60 participants; Kuntscher-Y nail with the SHS: 230 participants; Gamma nail and the Medoff sliding plate: 217 participants) failed to provide sufficient evidence to establish differences between implants in outcome. Two trials, involving 65 people with reverse and transverse fractures at the level of the lesser trochanter, found intramedullary nails (Gamma nail or PFN) were associated with better intra-operative results and fewer fracture fixation complications than extramedullary implants (a 90-degree blade plate or dynamic condylar plate) for these fractures. AUTHORS' CONCLUSIONS: Given the lower complication rate of the SHS in comparison with intramedullary nails, SHS appears superior for trochanteric fractures. Further studies are required to determine if different types of intramedullary nail produce similar results, or if intramedullary nails have advantages for selected fracture types (for example, subtrochanteric fractures).