Navigation System-Assisted vs Freehand Cannulated Screw Fixation for Femoral Neck Fractures: Protocol for a Multicenter Randomized Controlled Trial.

backgroundThe incidence of femoral neck fractures (FNFs) is increasing, primarily due to an aging population and an increased incidence of high-energy trauma. Although fixation with three cannulated screws (TCS) is the most commonly used surgical technique, it has limitations, including suboptimal operative accuracy and dependence on repeated intraoperative fluoroscopy. In response, advanced navigation systems have been developed to improve surgical precision and outcomes.

objectiveThis multicenter, prospective, randomized controlled superiority trial will compare surgical outcomes between an intelligent navigation system and the conventional freehand technique for FNF, as well as long-term fracture healing and complication rates.

methodsThis multicenter, prospective, randomized controlled superiority trial will compare navigation system-assisted TCS fixation with conventional freehand TCS fixation in patients with FNF from June 2024 to October 2026. Eligible participants are adults aged ≥18 years diagnosed with FNF who are indicated for internal fixation. The primary outcome is the frequency of intraoperative fluoroscopy. Secondary outcomes include the neck-shaft angle, guide wire placement quality, operative time, intraoperative blood loss, fracture healing status, the Harris Hip Score, the 36-Item Short Form Health Survey, and the Zarit Caregiver Burden Score. The sample size calculation indicated that 150 (50%) participants per group (N=300) would be needed to detect a superiority margin of 15.4 fluoroscopy images with 80% power and a 1-sided α of .025, accounting for a 15% dropout rate. All patients will undergo 12 months of follow-up. Data analysis will compare groups using 1-sided t tests and Mann-Whitney U tests, supplemented by linear mixed-effects models with study site as a random effect.

resultsThe study was funded in May 2024 and received initial ethics approval from the institutional review board. Patient enrollment commenced in June 2024 and is projected to be completed by October 2026, with a target sample size of 300 participants. The final 12-month follow-up is expected to be completed by October 2027. As of manuscript submission, recruitment is ongoing, and no data analysis has been performed.

conclusionsSuccessful completion of this study may introduce a new strategy for the management of FNF and help establish a standardized protocol for the use of navigation systems, potentially enhancing clinical outcomes and reducing complication rates.

trial registrationClinicalTrials.gov NCT06713018; https://clinicaltrials.gov/study/NCT06713018. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/88180.