Interventions for treating proximal humeral fractures in adults.

BACKGROUND: Fractures of the proximal humerus, often termed shoulder fractures, are common injuries, especially in older people. The management of these fractures varies widely, including in the use of surgery. This is an update of a Cochrane Review first published in 2001 and last updated in 2015. OBJECTIVES: To assess the effects (benefits and harms) of treatment and rehabilitation interventions for proximal humeral fractures in adults. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, trial registries, and bibliographies of trial reports and systematic reviews to September 2020. We updated this search in November 2021, but have not yet incorporated these results. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials that compared non-pharmacological interventions for treating acute proximal humeral fractures in adults.  DATA COLLECTION AND ANALYSIS: Pairs of review authors independently selected studies, assessed risk of bias and extracted data. We pooled data where appropriate and used GRADE for assessing the certainty of evidence for each outcome. We prepared a brief economic commentary for one comparison. MAIN RESULTS: We included 47 trials (3179 participants, mostly women and mainly aged 60 years or over) that tested one of 26 comparisons. Six comparisons were tested by 2 to 10 trials, the others by small single-centre trials only. Twelve studies evaluated non-surgical treatments, 10 compared surgical with non-surgical treatments, 23 compared two methods of surgery, and two tested timing of mobilisation after surgery. Most trials were at high risk of bias, due mainly to lack of blinding. We summarise the findings for four key comparisons below. Early (usually one week post injury) versus delayed (after three or more weeks) mobilisation for non-surgically-treated fractures Five trials (350 participants) made this comparison; however, the available data are very limited. Due to very low-certainty evidence from single trials, we are uncertain of the findings of better shoulder function at one year in the early mobilisation group, or the findings of little or no between-group difference in function at 3 or 24 months. Likewise, there is very low-certainty evidence of no important between-group difference in quality of life at one year. There was one reported death and five serious shoulder complications (1.9% of 259 participants), spread between the two groups, that would have required substantive treatment. Surgical versus non-surgical treatment Ten trials (717 participants) evaluated surgical intervention for displaced fractures (66% were three- or four-part fractures). There is high-certainty evidence of no clinically important difference between surgical and non-surgical treatment in patient-reported shoulder function at one year (standardised mean difference (SMD) 0.10, 95% confidence interval (CI) -0.07 to 0.27; 7 studies, 552 participants) and two years (SMD 0.06, 95% CI -0.13 to 0.25; 5 studies, 423 participants). There is moderate-certainty evidence of no clinically important between-group difference in patient-reported shoulder function at six months (SMD 0.17, 95% CI -0.04 to 0.38; 3 studies, 347 participants). There is high-certainty evidence of no clinically important between-group difference in quality of life at one year (EQ-5D (0: dead to 1: best quality): mean difference (MD) 0.01, 95% CI -0.02 to 0.04; 6 studies, 502 participants). There is low-certainty evidence of little between-group difference in mortality: one of the 31 deaths was explicitly linked with surgery (risk ratio (RR) 1.35, 95% CI 0.70 to 2.62; 8 studies, 646 participants). There is low-certainty evidence of a higher risk of additional surgery in the surgery group (RR 2.06, 95% CI 1.21 to 3.51; 9 studies, 667 participants). Based on an illustrative risk of 35 subsequent operations per 1000 non-surgically-treated patients, this indicates an extra 38 subsequent operations per 1000 surgically-treated patients (95% CI 8 to 94 more). Although there was low-certainty evidence of a higher overall risk of adverse events after surgery, the 95% CI also includes a slightly increased risk of adverse events after non-surgical treatment (RR 1.46, 95% CI 0.92 to 2.31; 3 studies, 391 participants). Open reduction and internal fixation with a locking plate versus a locking intramedullary nail Four trials (270 participants) evaluated surgical intervention for displaced fractures (63% were two-part fractures). There is low-certainty evidence of no clinically important between-group difference in shoulder function at one year (SMD 0.15, 95% CI -0.12 to 0.41; 4 studies, 227 participants), six months (Disability of the Arm, Shoulder, and Hand questionnaire (0 to 100: worst disability): MD -0.39, 95% CI -4.14 to 3.36; 3 studies, 174 participants), or two years (American Shoulder and Elbow Surgeons score (ASES) (0 to 100: best outcome): MD 3.06, 95% CI -0.05 to 6.17; 2 studies, 101 participants). There is very low-certainty evidence of no between-group difference in quality of life (1 study), and of little difference in adverse events (4 studies, 250 participants) and additional surgery (3 studies, 193 participants). Reverse total shoulder arthroplasty (RTSA) versus hemiarthroplasty There is very low-certainty evidence from two trials (161 participants with either three- or four-part fractures) of no or minimal between-group differences in self-reported shoulder function at one year (1 study) or at two to three years' follow-up (2 studies); or in quality of life at one year or at two or more years' follow-up (1 study). Function at six months was not reported. Of 10 deaths reported by one trial (99 participants), one appeared to be surgery-related. There is very low-certainty evidence of a lower risk of complications after RTSA (2 studies). Ten people (6.2% of 161 participants) had a reoperation; all eight cases in the hemiarthroplasty group received a RTSA (very low-certainty evidence). AUTHORS' CONCLUSIONS: There is high- or moderate-certainty evidence that, compared with non-surgical treatment, surgery does not result in a better outcome at one and two years after injury for people with displaced proximal humeral fractures. It may increase the need for subsequent surgery. The evidence is absent or insufficient for people aged under 60 years, high-energy trauma, two-part tuberosity fractures or less common fractures, such as fracture dislocations and articular surface fractures. There is insufficient evidence from randomised trials to inform the choices between different non-surgical, surgical or rehabilitation interventions for these fractures.

Multidisciplinary rehabilitation for older people with hip fractures.

BACKGROUND: Hip fracture is a major cause of morbidity and mortality in older people, and its impact on society is substantial. After surgery, people require rehabilitation to help them recover. Multidisciplinary rehabilitation is where rehabilitation is delivered by a multidisciplinary team, supervised by a geriatrician, rehabilitation physician or other appropriate physician. This is an update of a Cochrane Review first published in 2009. OBJECTIVES: To assess the effects of multidisciplinary rehabilitation, in either inpatient or ambulatory care settings, for older people with hip fracture. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, CENTRAL, MEDLINE and Embase (October 2020), and two trials registers (November 2019). SELECTION CRITERIA: We included randomised and quasi-randomised trials of post-surgical care using multidisciplinary rehabilitation of older people (aged 65 years or over) with hip fracture. The primary outcome - 'poor outcome' - was a composite of mortality and decline in residential status at long-term (generally one year) follow-up. The other 'critical' outcomes were health-related quality of life, mortality, dependency in activities of daily living, mobility, and related pain. DATA COLLECTION AND ANALYSIS: Pairs of review authors independently performed study selection, assessed risk of bias and extracted data. We pooled data where appropriate and used GRADE for assessing the certainty of evidence for each outcome. MAIN RESULTS: The 28 included trials involved 5351 older (mean ages ranged from 76.5 to 87 years), usually female, participants who had undergone hip fracture surgery. There was substantial clinical heterogeneity in the trial interventions and populations. Most trials had unclear or high risk of bias for one or more items, such as blinding-related performance and detection biases. We summarise the findings for three comparisons below. Inpatient rehabilitation: multidisciplinary rehabilitation versus 'usual care' Multidisciplinary rehabilitation was provided primarily in an inpatient setting in 20 trials. Multidisciplinary rehabilitation probably results in fewer cases of 'poor outcome' (death or deterioration in residential status, generally requiring institutional care) at 6 to 12 months' follow-up (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.80 to 0.98; 13 studies, 3036 participants; moderate-certainty evidence). Based on an illustrative risk of 347 people with hip fracture with poor outcome in 1000 people followed up between 6 and 12 months, this equates to 41 (95% CI 7 to 69) fewer people with poor outcome after multidisciplinary rehabilitation. Expressed in terms of numbers needed to treat for an additional harmful outcome (NNTH), 25 patients (95% CI 15 to 100) would need to be treated to avoid one 'poor outcome'. Subgroup analysis by type of multidisciplinary rehabilitation intervention showed no evidence of subgroup differences. Multidisciplinary rehabilitation may result in fewer deaths in hospital but the confidence interval does not exclude a small increase in the number of deaths (RR 0.77, 95% CI 0.58 to 1.04; 11 studies, 2455 participants; low-certainty evidence). A similar finding applies at 4 to 12 months' follow-up (RR 0.91, 95% CI 0.80 to 1.05; 18 studies, 3973 participants; low-certainty evidence). Multidisciplinary rehabilitation may result in fewer people with poorer mobility at 6 to 12 months' follow-up (RR 0.83, 95% CI 0.71 to 0.98; 5 studies, 1085 participants; low-certainty evidence). Due to very low-certainty evidence, we have little confidence in the findings for marginally better quality of life after multidisciplinary rehabilitation (1 study). The same applies to the mixed findings of some or no difference from multidisciplinary rehabilitation on dependence in activities of daily living at 1 to 4 months' follow-up (measured in various ways by 11 studies), or at 6 to 12 months' follow-up (13 studies). Long-term hip-related pain was not reported. Ambulatory setting: supported discharge and multidisciplinary home rehabilitation versus 'usual care' Three trials tested this comparison in 377 people mainly living at home. Due to very low-certainty evidence, we have very little confidence in the findings of little to no between-group difference in poor outcome (death or move to a higher level of care or inability to walk) at one year (3 studies); quality of life at one year (1 study); in mortality at 4 or 12 months (2 studies); in independence in personal activities of daily living (1 study); in moving permanently to a higher level of care (2 studies) or being unable to walk (2 studies). Long-term hip-related pain was not reported. One trial tested this comparison in 240 nursing home residents. There is low-certainty evidence that there may be no or minimal between-group differences at 12 months in 'poor outcome' defined as dead or unable to walk; or in mortality at 4 months or 12 months. Due to very low-certainty evidence, we have very little confidence in the findings of no between-group differences in dependency at 4 weeks or at 12 months, or in quality of life, inability to walk or pain at 12 months. AUTHORS' CONCLUSIONS: In a hospital inpatient setting, there is moderate-certainty evidence that rehabilitation after hip fracture surgery, when delivered by a multidisciplinary team and supervised by an appropriate medical specialist, results in fewer cases of 'poor outcome' (death or deterioration in residential status). There is low-certainty evidence that multidisciplinary rehabilitation may result in fewer deaths in hospital and at 4 to 12 months; however, it may also result in slightly more. There is low-certainty evidence that multidisciplinary rehabilitation may reduce the numbers of people with poorer mobility at 12 months. No conclusions can be drawn on other outcomes, for which the evidence is of very low certainty. The generally very low-certainty evidence available for supported discharge and multidisciplinary home rehabilitation means that we are very uncertain whether the findings of little or no difference for all outcomes between the intervention and usual care is true. Given the prevalent clinical emphasis on early discharge, we suggest that research is best orientated towards early supported discharge and identifying the components of multidisciplinary inpatient rehabilitation to optimise patient recovery within hospital and the components of multidisciplinary rehabilitation, including social care, subsequent to hospital discharge.

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. This is an update of a Cochrane Review published in 2007. OBJECTIVES: To assess the effects (benefits and harms) of percutaneous pinning versus cast immobilisation alone and of different methods and techniques of percutaneous pinning, modalities or duration of immobilisation after pinning, and methods or timing of pin or wire removal for treating fractures of the distal radius in adults. Our primary focus was on dorsally displaced fractures. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, trial registers, conference proceedings and reference lists of articles up to June 2019. SELECTION CRITERIA: Randomised or quasi-randomised controlled clinical trials involving adults with a fracture of the distal radius, which compared percutaneous pinning with non-surgical treatment or different aspects of percutaneous pinning. Our main outcomes were patient-reported function at the short term (up to three months), medium term (three up to 12 months) and long term (greater than 12 months); overall numbers of participants with complications requiring secondary treatment and any complication; grip strength and health-related quality of life at 12 months. DATA COLLECTION AND ANALYSIS: At least two review authors independently performed study screening and selection, 'Risk of bias' assessment and data extraction. We pooled data where appropriate and used GRADE for assessing the quality of evidence for each outcome. MAIN RESULTS: We included 21 randomised controlled trials (RCTs) and five quasi-RCTs, involving 1946 generally older and female adults with dorsally displaced and potentially or evidently unstable distal radial fractures. Trial populations varied but the majority of studies reported mean ages in the sixth decade or older. All trials were at high risk of bias, invariably performance bias - which for most trials reflected the impracticality of blinding care providers or participants to treatment allocation - and often detection bias and selective reporting bias. Allocation concealment was secure in one trial only. All trials reported outcomes incompletely. The studies tested one of 10 comparisons. In the following, we report on those of the main outcomes for which evidence was available. No subgroup analysis, such as by pinning methods, was viable. Eleven heterogeneous trials involving 917 participants compared percutaneous pinning with plaster cast immobilisation after closed reduction of the fracture. The quality of the evidence was very low for all reported outcomes. Thus, we are uncertain if percutaneous pinning compared with plaster cast alone makes any difference to patient-reported function, measured using the DASH questionnaire, at six weeks or six months (incomplete data from one trial). Overall numbers of participants with complications were not reported. Redisplacement resulting in secondary treatment occurred on average in 12% (range 3.3% to 75%) of participants treated by cast alone (six trials) whereas pin tract infection requiring antibiotics and, often, early wire removal, occurred on average in 7.7% (range 0% to 15%) of pinning group participants (seven trials). We are uncertain whether pinning makes a difference to the incidence of complex regional pain syndrome, reported in four studies. Although two studies found finger stiffness after cast removal was less common after pinning (20% versus 36%), the treatment implications were not reported. Other reported complications were mainly surgery-related. Based on incomplete data or qualitative statements from only four studies, we are uncertain of the effects of pinning on grip strength at 12 months. We are uncertain if percutaneous pinning compared with plaster cast alone makes any difference to patient-reported quality of life at four months (one study). Five comparisons of different pinning methods were made by six trials in all. One of these trials, which reported results for 96 participants, compared Kapandji intrafocal pinning (2 or 3 wires) with early mobilisation versus trans-styloid fixation (2 wires) with six weeks cast immobilisation. We are uncertain whether Kapandji pinning slightly increases the risk of superficial radial nerve symptoms or complex regional pain syndrome, or whether it makes a difference in grip strength at 12 months (very low-quality evidence). Two small trials using two distinct pinning techniques compared biodegradable pins versus metal pins in 70 participants. Although very low-quality evidence, the extra demands at surgery of insertion of biodegradable pins and excess of serious complications (e.g. severe osteolytic reactions) associated with biodegradable material are important findings. Three poorly-reported trials involving 168 participants compared burying of wire ends versus leaving them exposed. We are uncertain whether burying of wires reduces the incidence of superficial infection (very low-quality evidence). There is low-quality evidence that burying of wires may be associated with a higher risk of requiring more invasive treatment for wire removal. Four small trials compared different types or duration of postoperative immobilisation. Very low-quality evidence of small between-group differences in individual complications and grip strength at 17 weeks, means we are uncertain of the effects of positioning the wrist in dorsiflexion versus palmar flexion during cast immobilisation following pinning of redisplaced fractures (one trial; 60 participants). Three small heterogeneous trials compared cast immobilisation for one week (early mobilisation) versus four or six weeks after percutaneous pinning in 170 people. Although we note one trial using Kapandji pinning reported more complications in the early group, the very low-quality evidence means there is uncertainty of the effects of early mobilisation on overall and individual complications, or grip strength at 12 months. No trials tested different methods for, or timing of, pin/wire removal. AUTHORS' CONCLUSIONS: Overall, there is insufficient RCT evidence to inform on the role of percutaneous pinning versus cast immobilisation alone or associated treatment decisions such as method of pinning, burying or not of wire ends, wrist position and duration of immobilisation after pinning. Although very low-quality evidence, the serious complications associated with biodegradable materials is noteworthy. We advise waiting on the results of a large ongoing study comparing pinning with plaster cast treatment as these could help inform future research.

The impact of surgeon and patient treatment preferences in an orthopaedic trauma surgery trial.

BACKGROUND: Surgeon and patient treatment preferences are important threats to the internal and external validity of surgical trials such as PROFHER, which compared surgical versus non-surgical treatment for displaced fractures of the proximal humerus in adults. We explored the treatment preferences expressed by surgeons and patients in the trial and how these impacted on patient selection, trial conduct and patient outcome. METHODS: A series of exploratory secondary analyses of the PROFHER trial data were undertaken. We reviewed the extent of surgeon and patient treatment preferences (surgery or not surgery) at screening (n = 1250) as well as prior preference (including no preference) of randomised patients (n = 250), and assessed their impact on recruitment and adherence to follow-up and rehabilitation. Changes in treatment after 2 years' follow-up were explored. Patient preference and characteristics associated with trial inclusion or treatment preference (t test, chi-squared test, Wilcoxon rank-sum test) were included as treatment interaction terms in the primary trial analysis of shoulder functioning (Oxford Shoulder Score, OSS). RESULTS: Surgeons excluded 17% of otherwise eligible patients based on lack of equipoise; these patients had less complex fractures (p < 0.001) and tended to be older (p = 0.062). Surgeons were more likely to recommend surgery for patients under 65 years of age (p = 0.059) and who had injured their right shoulder (p = 0.052). Over half of eligible patients (56%) did not consent to take part in the trial; these patients tended to be older (p = 0.022), with a preference for not surgery (74%; which was associated with older age, p = 0.039). There were no differential treatment effects (p value of interaction) for shoulder functioning (OSS) based on subgroups of patient preference (p = 0.751), age group (p = 0.264), fracture type (p = 0.954) and shoulder dominance (p = 0.850). Patients who were randomised to their preferred treatment had better follow-up rates (94 vs 84% at 2 years) and treatment adherence (90 vs 83% reported completing home exercises). Patients who were not randomised to their preferred treatment were more likely to change their treatment preference at 24 months (60 vs 26%). CONCLUSIONS: The robustness of the PROFHER trial findings was confirmed against possible bias introduced by surgeon and patient preferences. The importance of collecting preference data is highlighted. TRIAL REGISTRATION: ISRCTN50850043 . Registered on 25 March 2008.

Interventions for treating wrist fractures in children.

BACKGROUND: Wrist fractures, involving the distal radius, are the most common fractures in children. Most are buckle fractures, which are stable fractures, unlike greenstick and other usually displaced fractures. There is considerable variation in practice, such as the extent of immobilisation for buckle fractures and use of surgery for seriously displaced fractures. OBJECTIVES: To assess the effects (benefits and harms) of interventions for common distal radius fractures in children, including skeletally immature adolescents. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group's Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, trial registries and reference lists to May 2018. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs comparing interventions for treating distal radius fractures in children. We sought data on physical function, treatment failure, adverse events, time to return to normal activities (recovery time), wrist pain, and child (and parent) satisfaction. DATA COLLECTION AND ANALYSIS: At least two review authors independently performed study screening and selection, 'Risk of bias' assessment and data extraction. We pooled data where appropriate and used GRADE for assessing the quality of evidence for each outcome. MAIN RESULTS: Of the 30 included studies, 21 were RCTs, seven were quasi-RCTs and two did not describe their randomisation method. Overall, 2930 children were recruited. Typically, trials included more male children and reported mean ages between 8 and 10 years. Eight studies recruited buckle fractures, five recruited buckle and other stable fractures, three recruited minimally displaced fractures and 14 recruited displaced fractures, typically requiring closed reduction, typically requiring closed reduction. All studies were at high risk of bias, mainly reflecting lack of blinding. The studies made 14 comparisons. Below we consider five prespecified comparisons:Removable splint versus below-elbow cast for predominantly buckle fractures (6 studies, 695 children)One study (66 children) reported similar Modified Activities Scale for Kids - Performance scores (0 to 100; no disability) at four weeks (median scores: splint 99.04; cast 99.11); low-quality evidence. Thirteen children needed a change or reapplication of device (splint 5/225; cast 8/219; 4 studies); very low-quality evidence. One study (87 children) reported no refractures at six months. One study (50 children) found no between-group difference in pain during treatment; very low-quality evidence. Evidence was absent (recovery time), insufficient (children with minor complications) or contradictory (child or parent satisfaction). Two studies estimated lower healthcare costs for removable splints.Soft or elasticated bandage versus below-elbow cast for buckle or similar fractures (4 studies, 273 children)One study (53 children) reported more children had no or only limited disability at four weeks in the bandage group; very low-quality evidence. Eight children changed device or extended immobilisation for delayed union (bandage 5/90; cast 3/91; 3 studies); very low-quality evidence. Two studies (139 children) reported no serious adverse events at four weeks. Evidence was absent, insufficient or contradictory for recovery time, wrist pain, children with minor complications, and child and parent satisfaction. More bandage-group participants found their treatment convenient (39 children).Removal of casts at home by parents versus at the hospital fracture clinic by clinicians (2 studies, 404 children, mainly buckle fractures)One study (233 children) found full restoration of physical function at four weeks; low-quality evidence. There were five treatment changes (home 4/197; hospital 1/200; 2 studies; very low-quality evidence). One study found no serious adverse effects at six months (288 children). Recovery time and number of children with minor complications were not reported. There was no evidence of a difference in pain at four weeks (233 children); low-quality evidence. One study (80 children) found greater parental satisfaction in the home group; low-quality evidence. One UK study found lower healthcare costs for home removal.Below-elbow versus above-elbow casts for displaced or unstable both-bone fractures (4 studies, 399 children)Short-term physical function data were unavailable but very low-quality evidence indicated less dependency when using below-elbow casts. One study (66 children with minimally displaced both-bone fractures) found little difference in ABILHAND-Kids scores (0 to 42; no problems) (mean scores: below-elbow 40.7; above-elbow 41.8); very low-quality evidence. Overall treatment failure data are unavailable, but nine of the 11 remanipulations or secondary reductions (366 children, 4 studies) were in the above-elbow group; very low-quality evidence. There was no refracture or compartment syndrome at six months (215 children; 2 studies). Recovery time and overall numbers of children with minor complications were not reported. There was little difference in requiring physiotherapy for stiffness (179 children, 2 studies); very low-quality evidence. One study (85 children) found less pain at one week for below-elbow casts; low-quality evidence. One study found treatment with an above-elbow cast cost three times more in Nepal.Surgical fixation with percutaneous wiring and cast immobilisation versus cast immobilisation alone after closed reduction of displaced fractures (5 studies, 323 children)Where reported, above-elbow casts were used. Short-term functional outcome data were unavailable. One study (123 children) reported similar ABILHAND-Kids scores indicating normal physical function at six months (mean scores: surgery 41.9; cast only 41.4); low-quality evidence. There were fewer treatment failures, defined as early or problematic removal of wires or remanipulation for early loss in position, after surgery (surgery 20/124; cast only 41/129; 4 studies; very low-quality evidence). Similarly, there were fewer serious advents after surgery (surgery 28/124; cast only 43/129; 4 studies; very low-quality evidence). Recovery time, wrist pain, and satisfaction were not reported. There was lower referral for physiotherapy for stiffness after surgery (1 study); very low-quality evidence. One USA study found similar treatment costs in both groups. AUTHORS' CONCLUSIONS: Where available, the quality of the RCT-based evidence on interventions for treating wrist fractures in children is low or very low. However, there is reassuring evidence of a full return to previous function with no serious adverse events, including refracture, for correctly-diagnosed buckle fractures, whatever the treatment used. The review findings are consistent with the move away from cast immobilisation for these injuries. High-quality evidence is needed to address key treatment uncertainties; notably, some priority topics are already being tested in ongoing multicentre trials, such as FORCE.

Predicting the outcome of conservative treatment with physiotherapy in adults with shoulder pain associated with partial-thickness rotator cuff tears - a prognostic model development study.

BACKGROUND: Rotator cuff disorders represent the commonest type of painful shoulder complaints in clinical practice. Although conservative treatment including physiotherapy is generally recommended as first-line treatment, little is known about the precise treatment indications for subgroups of rotator cuff disorders, particularly people with shoulder pain associated with partial-thickness tears of the rotator cuff, PTTs: "symptomatic PPTs". The aim of this study was to develop a prognostic model for predicting the outcome of a phase of conservative treatment primarily with physiotherapy in adults with symptomatic PTTs. METHODS: A prospective observational cohort study was conducted in an outpatient setting in Germany. Ten baseline factors were selected to evaluate nine pre-defined multivariable candidate prognostic models (each including between two and nine factors) in a cohort of adults with symptomatic atraumatic PTTs undergoing a three-month phase of conservative treatment primarily with physiotherapy. The primary outcome was change in the Western Ontario Rotator Cuff Index. The models were developed using linear regression and an information-theoretic analysis approach: Akaike's Information Criterion (AICC). RESULTS: Eight candidate models were analyzed using data from 61 participants. Two "best models" were identified: smoking & pain catastrophizing and disability & pain catastrophizing. However, none of the models had a satisfactory performance or precision. CONCLUSIONS: We could not determine a prognostic model with satisfactory performance and precision. Further high-quality prognostic model studies with larger samples are needed, but should be underpinned, and thus preceded, by robust research that enhances knowledge of relevant prognostic factors. STUDY REGISTRATION: DRKS00004462 . Registered 08 April 2014; retrospectively registered (prior to the analysis).

Estimating the Minimal Important Difference for the Western Ontario Rotator Cuff Index (WORC) in adults with shoulder pain associated with partial-thickness rotator cuff tears.

BACKGROUND: Knowledge about Minimal Important Differences (MIDs) is essential for the interpretation of continuous outcomes, especially patient-reported outcome measures (PROMS). OBJECTIVE: The aim of this study was to estimate the MID for the Western Ontario Rotator Cuff Index (WORC: score 0 (best) to 2100 (worst disability)) in adults with shoulder pain associated with partial-thickness rotator cuff tears, 'symptomatic PTTs', undergoing conservative treatment with physiotherapy. DESIGN: A prospectively-designed anchor-based MID analysis using data from a prospective prognostic study with a three-month follow-up conducted within an outpatient care setting in Germany. METHODS: The MID was estimated using data from 64 adults with atraumatic symptomatic PTTs who underwent three months of conservative treatment with physiotherapy. The anchor was a seven-point Global Perceived Change (GPC) scale. RESULTS: Based on a definition of the MID being the threshold of "being (at least slightly) improved" with a probability nearest to 0.90 (i.e. 9 of 10 patients achieving the MID), the MID for the WORC was estimated as -300 for 'improved' shoulder-related disability in 9 out of 10 patients (95% CI 8 out of 10 patients to everyone) undergoing three months of exercise-based physiotherapy for symptomatic PTTs. CONCLUSIONS: This is the first published MID estimate for the WORC in adults with symptomatic PTTs of the rotator cuff undergoing typical treatment comprising conservative treatment with physiotherapy. The conceptual framework for interpretation facilitates its use in similar clinical contexts.

"Away Days" in multicenter randomized controlled trials: a questionnaire survey of their use and a case study on the effect of one Away Day on patient recruitment.

OBJECTIVE: "Away Days" (trial promotion and training events for trial site personnel) are a well-established method used by trialists to encourage engagement of research sites in the recruitment of patients to multicenter randomized controlled trials (RCTs). We explored the use of Away Days in multicenter RCTs and analyzed the effect on patient recruitment in a case study. METHODS: Members of the United Kingdom Trial Managers' Network were surveyed in June 2013 to investigate their experiences in the design and conduct of Away Days in RCTs. We used data from a multicenter pragmatic surgical trial to explore the effects of an Away Day on the screening and recruitment of patients. RESULTS: A total of 94 people responded to the survey. The majority (78%), who confirmed had organized an Away Day previously, found them to be useful. This is despite their costs. There was no evidence, however, from the analysis of data from a surgical trial that attendance at an Away Day increased the number of patients screened or recruited at participating sites. CONCLUSIONS: Although those responsible for managing RCTs in the UK tend to believe that trial Away Days are beneficial, evidence from a multicenter surgical trial shows no improvement on a key indicator of trial success. This points to the need to carefully consider the aims, design, and conduct of Away Days. Further more rigorous research nested within RCTs would be valuable to evaluate the design and conduct of Away Days.

Prognostic Models in Adults Undergoing Physical Therapy for Rotator Cuff Disorders: Systematic Review.

BACKGROUND: Rotator cuff-related disorders represent the largest subgroup of shoulder complaints. Despite the availability of various conservative and surgical treatment options, the precise indications for these options remain unclear. PURPOSE: The purpose of this systematic review was to synthesize the available research on prognostic models for predicting outcomes in adults undergoing physical therapy for painful rotator cuff disorders. DATA SOURCES: The MEDLINE, EMBASE, CINAHL, Cochrane CENTRAL, and PEDro databases and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) up to October 2015 were searched. STUDY SELECTION: The review included primary studies exploring prognostic models in adults undergoing physical therapy, with or without other conservative measures, for painful rotator cuff disorders. Primary outcomes were pain, disability, and adverse events. Inclusion was limited to prospective investigations of prognostic factors elicited at the baseline assessment. Study selection was independently performed by 2 reviewers. DATA EXTRACTION: A pilot-tested form was used to extract data on key aspects of study design, characteristics, analyses, and results. Risk of bias and applicability were independently assessed by 2 reviewers using the Prediction Study Risk of Bias Assessment tool (PROBAST). DATA SYNTHESIS: Five studies were included in the review. These studies were extremely heterogeneous in many aspects of design, conduct, and analysis. The findings were analyzed narratively. LIMITATIONS: All included studies were rated as at high risk of bias, and none of the resulting prognostic models was found to be usable in clinical practice. CONCLUSIONS: There are no prognostic models ready to inform clinical practice in the context of the review question, highlighting the need for further research on prognostic models for predicting outcomes in adults who undergo physical therapy for painful rotator cuff disorders. The design and conduct of future studies should be receptive to developing methods.

Interventions for treating proximal humeral fractures in adults.

BACKGROUND: Fracture of the proximal humerus, often termed shoulder fracture, is a common injury in older people. The management of these fractures varies widely. This is an update of a Cochrane Review first published in 2001 and last updated in 2012. OBJECTIVES: To assess the effects (benefits and harms) of treatment and rehabilitation interventions for proximal humeral fractures in adults. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and other databases, conference proceedings and bibliographies of trial reports. The full search ended in November 2014. SELECTION CRITERIA: We considered all randomised controlled trials (RCTs) and quasi-randomised controlled trials pertinent to the management of proximal humeral fractures in adults. DATA COLLECTION AND ANALYSIS: Both review authors performed independent study selection, risk of bias assessment and data extraction. Only limited meta-analysis was performed. MAIN RESULTS: We included 31 heterogeneous RCTs (1941 participants). Most of the 18 separate treatment comparisons were tested by small single-centre trials. The main exception was the surgical versus non-surgical treatment comparison tested by eight trials. Except for a large multicentre trial, bias in these trials could not be ruled out. The quality of the evidence was either low or very low for all comparisons except the largest comparison.Nine trials evaluated non-surgical treatment in mainly minimally displaced fractures. Four trials compared early (usually one week) versus delayed (three or four weeks) mobilisation after fracture but only limited pooling was possible and most of the data were from one trial (86 participants). This found some evidence that early mobilisation resulted in better recovery and less pain in people with mainly minimally displaced fractures. There was evidence of little difference between the two groups in shoulder complications (2/127 early mobilisation versus 3/132 delayed mobilisation; 4 trials) and fracture displacement and non-union (2/52 versus 1/54; 2 trials).One quasi-randomised trial (28 participants) found the Gilchrist-type sling was generally more comfortable than the Desault-type sling (body bandage). One trial (48 participants) testing pulsed electromagnetic high-frequency energy provided no evidence. Two trials (62 participants) provided evidence indicating little difference in outcome between instruction for home exercises versus supervised physiotherapy. One trial (48 participants) reported, without presentable data, that home exercise alone gave better early and comparable long-term results than supervised exercise in a swimming pool plus home exercise.Eight trials, involving 567 older participants, evaluated surgical intervention for displaced fractures. There was high quality evidence of no clinically important difference in patient-reported shoulder and upper-limb function at one- or two-year follow-up between surgical (primarily locking plate fixation or hemiarthroplasty) and non-surgical treatment (sling immobilisation) for the majority of displaced proximal humeral fractures; and moderate quality evidence of no clinically important difference between the two groups in quality of life at two years (and at interim follow-ups at six and 12 months). There was moderate quality evidence of little difference between groups in mortality in the surgery group (17/248 versus 12/248; risk ratio (RR) 1.40 favouring non-surgical treatment, 95% confidence interval (CI) 0.69 to 2.83; P = 0.35; 6 trials); only one death was explicitly linked with the treatment. There was moderate quality evidence of a higher risk of additional surgery in the surgery group (34/262 versus 16/261; RR 2.06, 95% CI 1.18 to 3.60; P = 0.01; 7 trials). Although there was moderate evidence of a higher risk of adverse events after surgery, the 95% confidence intervals for adverse events also included the potential for a greater risk of adverse events after non-surgical treatment.Different methods of surgical management were tested in 12 trials. One trial (57 participants) comparing two types of locking plate versus a locking nail for treating two-part surgical neck fractures found some evidence of slightly better function after plate fixation but also of a higher rate of surgically-related complications. One trial (61 participants) comparing a locking plate versus minimally invasive fixation with distally inserted intramedullary K-wires found little difference between the two implants at two years. Compared with hemiarthroplasty, one trial (32 participants) found similar results with locking plate fixation in function and re-operation rates, whereas another trial (30 participants) reported all five re-operations occurred in the tension-band fixation group. One trial (62 participants) found better patient-rated (Quick DASH) and composite shoulder function scores at a minimum of two years follow-up and a lower incidence of re-operation and complications after reverse shoulder arthroplasty (RSA) compared with hemiarthroplasty.No important between-group differences were found in one trial (120 participants) comparing the deltoid-split approach versus deltopectoral approach for non-contact bridging plate fixation, and two trials (180 participants) comparing 'polyaxial' and 'monaxial' screws in locking plate fixation. One trial (68 participants) produced some preliminary evidence that tended to support the use of medial support locking screws in locking plate fixation. One trial (54 participants) found fewer adverse events, including re-operations, for the newer of two types of intramedullary nail. One trial (35 participants) found better functional results for one of two types of hemiarthroplasty. One trial (45 participants) found no important effects of tenodesis of the long head of the biceps for people undergoing hemiarthroplasty.Very limited evidence suggested similar outcomes from early versus later mobilisation after either surgical fixation (one trial: 64 participants) or hemiarthroplasty (one trial: 49 participants). AUTHORS' CONCLUSIONS: There is high or moderate quality evidence that, compared with non-surgical treatment, surgery does not result in a better outcome at one and two years after injury for people with displaced proximal humeral fractures involving the humeral neck and is likely to result in a greater need for subsequent surgery. The evidence does not cover the treatment of two-part tuberosity fractures, fractures in young people, high energy trauma, nor the less common fractures such as fracture dislocations and head splitting fractures.There is insufficient evidence from RCTs to inform the choices between different non-surgical, surgical, or rehabilitation interventions for these fractures.

Rehabilitation for distal radial fractures in adults.

BACKGROUND: Fracture of the distal radius is a common clinical problem, particularly in older people with osteoporosis. There is considerable variation in the management, including rehabilitation, of these fractures. This is an update of a Cochrane review first published in 2002 and last updated in 2006. OBJECTIVES: To examine the effects of rehabilitation interventions in adults with conservatively or surgically treated distal radial fractures. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL 2014; Issue 12), MEDLINE, EMBASE, CINAHL, AMED, PEDro, OTseeker and other databases, trial registers, conference proceedings and reference lists of articles. We did not apply any language restrictions. The date of the last search was 12 January 2015. SELECTION CRITERIA: Randomised controlled trials (RCTs) or quasi-RCTs 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 review authors independently screened and selected trials, and reviewed eligible trials. We contacted study authors for additional information. We did not pool data. MAIN RESULTS: We included 26 trials, involving 1269 mainly female and older patients. With few exceptions, these studies did not include people with serious fracture or treatment-related complications, or older people with comorbidities and poor overall function that would have precluded trial participation or required more intensive treatment. Only four of the 23 comparisons covered by these 26 trials were evaluated by more than one trial. Participants of 15 trials were initially treated conservatively, involving plaster cast immobilisation. Initial treatment was surgery (external fixation or internal fixation) for all participants in five trials. Initial treatment was either surgery or plaster cast alone in six trials. Rehabilitation started during immobilisation in seven trials and after post-immobilisation in the other 19 trials. As well as being small, the majority of the included trials had methodological shortcomings and were at high risk of bias, usually related to lack of blinding, that could affect the validity of their findings. Based on GRADE criteria for assessment quality, we rated the evidence for each of the 23 comparisons as either low or very low quality; both ratings indicate considerable uncertainty in the findings.For interventions started during immobilisation, there was very low quality evidence of improved hand function for hand therapy compared with instructions only at four days after plaster cast removal, with some beneficial effects continuing one month later (one trial, 17 participants). There was very low quality evidence of improved hand function in the short-term, but not in the longer-term (three months), for early occupational therapy (one trial, 40 participants), and of a lack of differences in outcome between supervised and unsupervised exercises (one trial, 96 participants).Four trials separately provided very low quality evidence of clinically marginal benefits of specific interventions applied in addition to standard care (therapist-applied programme of digit mobilisation during external fixation (22 participants); pulsed electromagnetic field (PEMF) during cast immobilisation (60 participants); cyclic pneumatic soft tissue compression using an inflatable cuff placed under the plaster cast (19 participants); and cross-education involving strength training of the non-fractured hand during cast immobilisation with or without surgical repair (39 participants)).For interventions started post-immobilisation, there was very low quality evidence from one study (47 participants) of improved function for a single session of physiotherapy, primarily advice and instructions for a home exercise programme, compared with 'no intervention' after cast removal. There was low quality evidence from four heterogeneous trials (30, 33, 66 and 75 participants) of a lack of clinically important differences in outcome in patients receiving routine physiotherapy or occupational therapy in addition to instructions for home exercises versus instructions for home exercises from a therapist. There was very low quality evidence of better short-term hand function in participants given physiotherapy than in those given either instructions for home exercises by a surgeon (16 participants, one trial) or a progressive home exercise programme (20 participants, one trial). Both trials (46 and 76 participants) comparing physiotherapy or occupational therapy versus a progressive home exercise programme after volar plate fixation provided low quality evidence in favour of a structured programme of home exercises preceded by instructions or coaching. One trial (63 participants) provided very low quality evidence of a short-term, but not persisting, benefit of accelerated compared with usual rehabilitation after volar plate fixation.For trials testing single interventions applied post-immobilisation, there was very low quality evidence of no clinically significant differences in outcome in patients receiving passive mobilisation (69 participants, two trials), ice (83 participants, one trial), PEMF (83 participants, one trial), PEMF plus ice (39 participants, one trial), whirlpool immersion (24 participants, one trial), and dynamic extension splint for patients with wrist contracture (40 participants, one trial), compared with no intervention. This finding applied also to the trial (44 participants) comparing PEMF versus ice, and the trial (29 participants) comparing manual oedema mobilisation versus traditional oedema treatment. There was very low quality evidence from single trials of a short-term benefit of continuous passive motion post-external fixation (seven participants), intermittent pneumatic compression (31 participants) and ultrasound (38 participants). AUTHORS' CONCLUSIONS: The available evidence from RCTs is insufficient to establish the relative effectiveness of the various interventions used in the rehabilitation of adults with fractures of the distal radius. Further randomised trials are warranted. However, in order to optimise research effort and engender the large multicentre randomised trials that are required to inform practice, these should be preceded by research that aims to identify priority questions.

The ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial - a pragmatic multicentre randomised controlled trial evaluating the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment for proximal fracture of the humerus in adults.

BACKGROUND: Proximal humeral fractures account for 5-6% of all fractures in adults. There is considerable variation in whether or not surgery is used in the management of displaced fractures involving the surgical neck. OBJECTIVE: To evaluate the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment of the majority of displaced fractures of the proximal humerus involving the surgical neck in adults. DESIGN: A pragmatic parallel-group multicentre randomised controlled trial with an economic evaluation. Follow-up was for 2 years. SETTING: Recruitment was undertaken in the orthopaedic departments of 33 acute NHS hospitals in the UK. Patient care pathways included outpatient and community-based rehabilitation. PARTICIPANTS: Adults (aged ≥ 16 years) presenting within 3 weeks of their injury with a displaced fracture of the proximal humerus involving the surgical neck. INTERVENTIONS: The choice of surgical intervention was left to the treating surgeons, who used techniques with which they were experienced. Non-surgical treatment was initial sling immobilisation followed by active rehabilitation. Provision of rehabilitation was comparable in both groups. MAIN OUTCOME MEASURES: The primary outcome was the Oxford Shoulder Score (OSS) assessed at 6, 12 and 24 months. Secondary outcomes were the 12-item Short Form health survey, surgical and other shoulder fracture-related complications, secondary surgery to the shoulder or increased/new shoulder-related therapy, medical complications during inpatient stay and mortality. European Quality of Life-5 Dimensions data and treatment costs were also collected. RESULTS: The mean age of the 250 trial participants was 66 years and 192 (77%) were female. Independent assessment using the Neer classification identified 18 one-part fractures, 128 two-part fractures and 104 three- or four-part fractures. OSS data were available for 215 participants at 2 years. We found no statistically or clinically significant differences in OSS scores between the two treatment groups (scale 0-48, with a higher score indicating a better outcome) over the 2-year period [difference of 0.75 points in favour of the surgery group, 95% confidence interval (CI) -1.33 to 2.84; p = 0.479; data from 114 surgery and 117 non-surgery participants] or at individual time points. We found no statistically significant differences between surgical and non-surgical group participants in SF-12 physical or mental component summary scores; surgical or shoulder fracture-related complications (30 vs. 23 respectively); those undergoing further shoulder-related therapy, either surgery (11 vs. 11 respectively) or other therapy (seven vs. four respectively); or mortality (nine vs. five respectively). The base-case economic analysis showed that, at 2 years, the cost of surgical intervention was, on average, £1780.73 more per patient (95% CI £1152.71 to £2408.75) than the cost of non-surgical intervention. It was also slightly less beneficial in terms of utilities, although this difference was not statistically significant. The net monetary benefit associated with surgery is negative. There was only a 5% probability of surgery achieving the criterion of costing < £20,000 to gain a quality-adjusted life-year, which was confirmed by extensive sensitivity analyses. CONCLUSIONS: Current surgical practice does not result in a better outcome for most patients with displaced fractures of the proximal humerus involving the surgical neck and is not cost-effective in the UK setting. Two areas for future work are the setting up of a national database of these fractures, including the collection of patient-reported outcomes, and research on the best ways of informing patients with these and other upper limb fractures about initial self-care. TRIAL REGISTRATION: Current Controlled Trials ISRCTN50850043. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 24. See the NIHR Journals Library website for further project information.

Surgical vs nonsurgical treatment of adults with displaced fractures of the proximal humerus: the PROFHER randomized clinical trial.

IMPORTANCE: The need for surgery for the majority of patients with displaced proximal humeral fractures is unclear, but its use is increasing. OBJECTIVE: To evaluate the clinical effectiveness of surgical vs nonsurgical treatment for adults with displaced fractures of the proximal humerus involving the surgical neck. DESIGN, SETTING, AND PARTICIPANTS: A pragmatic, multicenter, parallel-group, randomized clinical trial, the Proximal Fracture of the Humerus Evaluation by Randomization (PROFHER) trial, recruited 250 patients aged 16 years or older (mean age, 66 years [range, 24-92 years]; 192 [77%] were female; and 249 [99.6%] were white) who presented at the orthopedic departments of 32 acute UK National Health Service hospitals between September 2008 and April 2011 within 3 weeks after sustaining a displaced fracture of the proximal humerus involving the surgical neck. Patients were followed up for 2 years (up to April 2013) and 215 had complete follow-up data. The data for 231 patients (114 in surgical group and 117 in nonsurgical group) were included in the primary analysis. INTERVENTIONS: Fracture fixation or humeral head replacement were performed by surgeons experienced in these techniques. Nonsurgical treatment was sling immobilization. Standardized outpatient and community-based rehabilitation was provided to both groups. MAIN OUTCOMES AND MEASURES: Primary outcome was the Oxford Shoulder Score (range, 0-48; higher scores indicate better outcomes) assessed during a 2-year period, with assessment and data collection at 6, 12, and 24 months. Sample size was based on a minimal clinically important difference of 5 points for the Oxford Shoulder Score. Secondary outcomes were the Short-Form 12 (SF-12), complications, subsequent therapy, and mortality. RESULTS: There was no significant mean treatment group difference in the Oxford Shoulder Score averaged over 2 years (39.07 points for the surgical group vs 38.32 points for the nonsurgical group; difference of 0.75 points [95% CI, -1.33 to 2.84 points]; P = .48) or at individual time points. There were also no significant between-group differences over 2 years in the mean SF-12 physical component score (surgical group: 1.77 points higher [95% CI, -0.84 to 4.39 points]; P = .18); the mean SF-12 mental component score (surgical group: 1.28 points lower [95% CI, -3.80 to 1.23 points]; P = .32); complications related to surgery or shoulder fracture (30 patients in surgical group vs 23 patients in nonsurgical group; P = .28), requiring secondary surgery to the shoulder (11 patients in both groups), and increased or new shoulder-related therapy (7 patients vs 4 patients, respectively; P = .58); and mortality (9 patients vs 5 patients; P = .27). Ten medical complications (2 cardiovascular events, 2 respiratory events, 2 gastrointestinal events, and 4 others) occurred in the surgical group during the postoperative hospital stay. CONCLUSIONS AND RELEVANCE: Among patients with displaced proximal humeral fractures involving the surgical neck, there was no significant difference between surgical treatment compared with nonsurgical treatment in patient-reported clinical outcomes over 2 years following fracture occurrence. These results do not support the trend of increased surgery for patients with displaced fractures of the proximal humerus. TRIAL REGISTRATION: isrctn.com Identifier: ISRCTN50850043.

Intramedullary nails for extracapsular hip fractures in adults.

BACKGROUND: Intramedullary nails may be used for the surgical fixation of extracapsular hip fractures in adults. This is an update of a Cochrane review first published in 2005 and last updated in 2008. OBJECTIVES: To assess the effects (benefits and harms) of different designs of intramedullary nails for treating extracapsular hip fractures in adults. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (6 January 2014), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 12, 2013), MEDLINE (1966 to November Week 3, 2013), MEDLINE In-Process & Other Non-Indexed Citations (3 January 2014), EMBASE (1988 to 2014, Week 1) and the World Health Organization (WHO) International Clinical Trials Registry Platform (accessed January 2014). SELECTION CRITERIA: All randomised or quasi-randomised trials comparing different types, or design modifications, of intramedullary nails in the treatment of extracapsular hip fractures in adults. DATA COLLECTION AND ANALYSIS: At least two review authors independently selected studies, assessed risk of bias and extracted data. We performed limited meta-analysis using the fixed-effect model. MAIN RESULTS: We included eight new trials, testing seven new comparisons in this update. Overall, we included 17 trials, testing 12 comparisons of different cephalocondylic nail designs. The trials involved a total of 2130 adults (predominantly female and older people) with mainly unstable trochanteric fractures.All trials were at unclear risk of bias for most domains, with the majority at high risk of detection bias for subjective outcomes. The three quasi-randomised trials were at high risk for selection bias.Four trials (910 participants) compared the proximal femoral nail (PFN) with the Gamma nail. There was no significant difference between the two implants in functional outcome (the very low quality evidence being limited to results from single trials), mortality (low quality evidence: 86/415 versus 80/415; risk ratio (RR) 1.08, 95% confidence interval (CI) 0.82 to 1.41), serious fixation complications (operative fracture of the femur, cut-out, non-union and later fracture of the femur) nor re-operations (low quality evidence: 45/455 versus 36/455; RR 1.25, 95% CI 0.83 to 1.90).Two trials (185 participants) provided very low quality evidence of a lack of clinically significant difference in outcome (functional score, mortality, fracture fixation complications and re-operation) between the ACE trochanteric nail and the Gamma nail.Two trials (200 participants) provided very low quality evidence of a lack of significant difference in outcome (mobility score, pain, fracture fixation complications or re-operations) between the proximal femoral nail antirotation (PFNA) nail and the Gamma 3 nail.Seven of the nine trials evaluating different comparisons provided very low quality evidence of a lack of significant between-group differences in all of the reported main outcomes for the following comparisons: ACE trochanteric nail versus Gamma 3 nail (112 participants); gliding nail versus Gamma nail (80 participants); Russell-Taylor Recon nail versus long Gamma nail (34 participants, all under 50 years); proximal femoral nail antirotation (PFNA) nail versus Targon PF nail (80 participants); dynamically versus statically locked intramedullary hip screw (IMHS) nail (81 participants); sliding versus non-sliding Gamma 3 nail (80 participants, all under 60 years); and long versus standard PFNA nails (40 participants with reverse oblique fractures).The other two single comparison trials also provided very low quality evidence of a lack of significant between-group differences in all of the main outcomes with single exceptions. The trial (215 participants) comparing the ENDOVIS nail versus the IMHS nail found low quality evidence of poorer mobility in the ENDOVIS nail group, where more participants in this group were bedridden after their operation (29/105 versus 18/110; RR 1.69, 95% CI 1.00 to 2.85; P = 0.05). The trial (113 participants) comparing the InterTan nail versus the PFNA II nail found very low quality evidence that more PFNA II group participants experienced thigh pain (3/47 versus 12/46; RR: 0.24, 95% CI 0.07 to 0.81). 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 treating 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.