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.
Intramedullary nails are commonly used to repair femoral fractures. Fractures in normal healthy bone often occur in the young during motor vehicle accidents. Although clinically beneficial, bone refracture and implant failure persist. Large variations in human femur quality and geometry have motivated recent experimental use of synthetic femurs that mimic human tissue and the development of increasingly sophisticated theoretical models. Four synthetic femurs were fitted with a T2 femoral nailing system (Stryker, Mahwah, New Jersey, USA). The femurs were not fractured in order to simulate post-operative perfect union. Six configurations were created: retrograde nail with standard locking (RS), retrograde nail with advanced locking 'off' (RA-off), retrograde nail with advanced locking 'on' (RA-on), antegrade nail with standard locking (AS), antegrade nail with advanced locking 'off' (AA-off), and antegrade nail with advanced locking 'on' (AA-on). Strain gauges were placed on the medial side of femurs. A 580 N axial load was applied, and the stiffness was measured. Strains were recorded and compared with results from a three-dimensional finite element (FE) model. Experimental axial stiffnesses for RA-off (771.3 N/mm) and RA-on (681.7 N/mm) were similar to intact human cadaveric femurs from previous literature (757 + 264 N/mm). Conversely, experimental axial stiffnesses for AS (1168.8N/mm), AA-off (1135.3N/mm), AA-on (1152.1 N/mm), and RS (1294.0 N/mm) were similar to intact synthetic femurs from previous literature (1290 +/- 30 N/mm). There was better agreement between experimental and FE analysis strains for RS (average percentage difference, 11.6 per cent), RA-on (average percentage difference, 11.1 per cent), AA-off (average percentage difference, 13.4 per cent), and AA-on (average percentage difference, 16.0 per cent), than for RA-off (average percentage difference, 33.5 per cent) and AS (average percentage difference, 32.6 per cent). FE analysis was more predictive of strains in the proximal and middle sections of the femur-nail construct than the distal. The results mimicked post-operative clinical stability at low static axial loads once fracture healing begins to occur.
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