Study protocol: HipSTHeR - a register-based randomised controlled trial – hip screws or (total) hip replacement for undisplaced femoral neck fractures in older patients

Background Femoral neck fractures (FNFs), which are common in the older population, are associated with high mortality and morbidity. Some 20% of FNFs are undisplaced (uFNFs). The routine surgical procedure for uFNFs is internal fixation (IF) with 2–3 screws/pins with a reported reoperation rate in older patients (age ≥ 75 years) of up to 21%. The reoperation rate for hemiarthroplasties for displaced fractures is lower than for undisplaced fractures operated with IF. This study will aim to determine whether the outcome for older patients with an uFNF can be improved by replacing the hip instead of preserving it. Methods A national multicentre, register-based, randomised controlled trial (rRCT) will be conducted. For this trial, 1440 patients, ≥75 years with an acute uFNF, will be allocated. Eligible patients will be identified by the Swedish Fracture Register (SFR) platform, which will notify the admitting orthopaedic surgeon of eligibility. After informed consent has been given and documented, patients will be randomised to either IF (control group) or arthroplasty (intervention group) within the SFR platform. Injury mechanism, fracture classification, date of injury, and type of treatment are registered in the SFR. Type and brand of arthroplasty, surgical approach, and fixation are obtained from the Swedish Hip Arthroplasty Register (SHAR). The study cohort from the SFR will be cross-checked with the National Patient Register and the SHAR for outcome variables at 2, 5, and 10 years. The primary outcome will be a composite variable comprising reoperation rate and mortality at 2 years postoperatively. Secondary endpoints will include reoperation rate and mortality as stand-alone variables. In addition, secondary endpoints will be patient-reported outcomes as measured by the Short Musculoskeletal Functional Assessment questionnaire at 1 year postoperatively as routinely collected within the SFR. Further secondary endpoints will include the occurrence of adverse events such as pneumonia, stroke or myocardial infarction and evaluation of the external validity of the study. Discussion This large, multicentre, register-based randomised controlled trial could potentially shift the treatment of uFNFs in older patients towards primary hip arthroplasty in order to improve the outcome. Trial registration The trial is registered at www.clinicaltrials.gov (NCT03966716); May 29, 2019.