JMIR Publications

ABSTRACT

Background:

The incidence of femoral neck fractures is increasing, primarily due to an aging population and a higher occurrence of high-energy trauma. Although fixation with three cannulated screws (TCS) is the most commonly used surgical technique, it presents 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, thereby justifying further comparative research.

Objective:

This multi-center, prospective, randomized controlled trial is designed to evaluate the efficacy of a novel navigation system-assisted fixation for femoral neck fractures.

Methods:

This multi-center, prospective, randomized controlled trial will compare navigation system-assisted cannulated screw fixation (NS+TCS) against conventional freehand TCS fixation in patients with femoral neck fractures. The primary outcome is the frequency of intraoperative fluoroscopy. Secondary outcomes include: (1) measurement of neck-shaft angle postoperatively, (2) assessment of the quality of guidewire placement, (3) recording of operative time, (4) quantification of intraoperative blood loss, (5) evaluation of fracture healing status through imaging, and (6) assessment of patient-reported outcomes and quality-of-life using the Harris Hip Score, SF-36, and Zarit Caregiver Burden Score. All patients will undergo a follow-up period of 12 months.

Results:

The study aims to enroll 300 participants from June 2024 to October 2026. This study received initial ethical approval from the Institutional Review Board of the coordinating center, Chinese PLA General Hospital (S2024-341-01), and is carried out as a multicenter investigation. Each collaborating site is required to secure approval from its local ethics committee prior to enrolling participants in the respective controlled cohort studies. yet. Data analysis will be performed after data collection ends, and results will be published afterward.

Conclusions:

The successful completion of this study will introduce a new strategy and establish a standardized protocol for using navigation systems in managing these fractures. Clinical Trial: This study was prospectively registered on the ClinicalTrials.gov (NCT06713018).