Summary Background Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a centralised computer system to receive a single large-diameter screw with a side-plate (sliding hip screw) or the present standard of care, multiple small-diameter cancellous screws. Surgeons and patients were not blinded but the data analyst, while doing the analyses, remained blinded to treatment groups. The primary outcome was hip reoperation within 24 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Analyses followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT00761813. Findings Between March 3, 2008, and March 31, 2014, we randomly assigned 1108 patients to receive a sliding hip screw (n=557) or cancellous screws (n=551). Reoperations within 24 months did not differ by type of surgical fixation in those included in the primary analysis: 107 (20%) of 542 patients in the sliding hip screw group versus 117 (22%) of 537 patients in the cancellous screws group (hazard ratio [HR] 0.83, 95% CI 0.63–1.09; p=0.18). Avascular necrosis was more common in the sliding hip screw group than in the cancellous screws group (50 patients [9%] vs 28 patients [5%]; HR 1.91, 1.06–3.44; p=0.0319). However, no significant difference was found between the number of medically related adverse events between groups (p=0.82; appendix); these events included pulmonary embolism (two patients [<1%] vs four [1%] patients; p=0.41) and sepsis (seven [1%] vs six [1%]; p=0.79). Interpretation In terms of reoperation rates the sliding hip screw shows no advantage, but some groups of patients (smokers and those with displaced or base of neck fractures) might do better with a sliding hip screw than with cancellous screws. Funding National Institutes of Health, Canadian Institutes of Health Research, Stichting NutsOhra, Netherlands Organisation for Health Research and Development, Physicians’ Services Incorporated.

Background: In Weber B/SER2-4 ankle fractures, assessment with weightbearing radiographs to ascertain stability of the ankle mortise has been advised. However, no previous studies report whether this method leads to preservation of normal ankle congruence. The purpose is to evaluate equivalence of ankle congruence of injured ankles after fracture union, vs the uninjured side, for stable SER2 and partially unstable SER4a fracture types. Methods: We conducted a prospective case-control study designed as an equivalence trial to evaluate if weightbearing radiographs predict whether stable/SER2 and partially unstable/SER4a Weber B ankle fractures reach union with preserved normal tibiotalar congruence and without a concomitant increase of treatment failure. A total of 149 patients with a Weber B fracture stable on weightbearing radiographs were recruited into the trial. All participants were treated with a functional orthosis and weightbearing allowed. Results from gravity stress radiographs classified ankles as SER2 or SER4a fracture types. We defined an equivalence margin in medial clear space difference of 1.0 mm. We also evaluated the reliability of obtaining measurements from weightbearing radiographs. Results: No differences in medial clear space between the injured and uninjured ankles were observed after fracture union for the SER2 group (mean difference 0.1 mm, 95% confidence interval [CI] −0.3, 0.0; P = .056), or the SER4a group (mean difference 0.0 mm (95% CI −0.1, 0.1; P = .797). No between-group differences were observed (mean difference 0.0 mm, 95% CI −0.2, 0.2; P = .842). These findings were consistent with equivalence. CIs for the intraclass correlation coefficients indicated excellent reliability. Conclusions: Assessment of stability of Weber B SER2/4a ankle fractures, with weightbearing radiographs, also predicts preservation of normal ankle congruence in those deemed stable, with no difference between SER2 and SER4a fracture types. Further, excellent reproducibility of the method of obtaining medial clear space measurements was demonstrated. Level of Evidence: Level III, case-control.

Level 1, randomized clinical trial.

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