Evaluation of Femoral Neck Fracture Migration After Internal Fixation With an Angle Stable Implant Compared With Gold Standard Cannulated Cancellous Screws in Young Adults: Study Protocol for a Clinical RCT Using Radiostereometric Analysis

What this Trial Is About

This research aims to compare different surgical methods for fixing femoral neck fractures in adults under 65 years old. It focuses on whether a new implant made of three angle-stable screws locked by a plate is as effective as the traditional cancellous screws or sliding hip screw in keeping the fracture stable during healing. The study will measure fracture movement after surgery using a precise imaging technique called radiostereometric analysis (RSA), while also tracking complications, pain, quality of life, and hip function over time. Participants will receive one of three internal fixation treatments: the novel Dynaloc implant, cannulated cancellous screws (CCS), or a sliding hip screw (SHS). Patients receiving Dynaloc or CCS will be randomly assigned, while those treated with SHS as standard care will be followed in a separate group. Surgeries will follow manufacturers' guidelines. Follow-up visits are scheduled at 6 weeks, 12 weeks, 6 months, and 12 months to monitor recovery. During the study, participants will undergo clinical assessments, CT scans, and specialized X-rays analyzed with AutoRSA. They will complete electronic questionnaires about pain, mobility, and quality of life. Data will be collected and verified at outpatient visits. The main outcome is fracture migration measured at 12 weeks, with other outcomes tracked at various times. Safety, complications, reoperations, and mortality will also be recorded during the 12-week period. The study plans to enroll enough patients to have 25 in each treatment group complete the primary follow-up.

Evaluation of Fracture Migration After Internal Fixation of Femoral Neck Fractures in Younger Adults: A Clinical RCT Using RSA