Dual versus single implant fixation for geriatric distal femur fractures: protocol for a randomised, controlled pilot study at five US level 1 trauma centres
Introduction Geriatric distal femur fractures are associated with mortality rates exceeding 20%, comparable to hip fractures. Traditional single implant fixation often requires weight-bearing restrictions that delay recovery. This pilot study aims to assess the feasibility of conducting a multicentre randomised controlled trial comparing dual vs single implant fixation for geriatric distal femur fractures. Methods and analysis This multicentre, prospective, randomised controlled pilot trial will enrol 80 participants aged 60 years or older with displaced distal femur fractures at five US level 1 trauma centres. Patients will be randomly allocated 1:1 to receive either single implant (lateral plate or retrograde nail) or dual implant (nail-plate or dual plate) fixation. All patients will be permitted immediate weight-bearing. The primary outcome is feasibility assessed through enrolment rate (80 patients in 12 months), protocol adherence (≥90%) and follow-up retention (≥85% at 12 months). Secondary outcomes include post-surgical mobility (AM-PAC, TUG), patient-reported outcomes (PROMIS-PF, PROMIS-29), mortality (90-day and 1 year) and complication rates. Analyses will be on an intention-to-treat basis. Ethics and dissemination The protocol was approved by the University of Utah Institutional Review Board (IRB_00149119) and IRBs at all participating centres. Written informed consent will be obtained from participants or legally authorised representatives. Findings will be disseminated through peer-reviewed publications and conference presentations. Trial registration number NCT05292313 .
Validation of Neck-Shaft Angle Correction After Cephalomedullary Nail Fixation
Objectives: To validate a neck-shaft angle (NSA) correction formula using the known angle between the medullary nail and lag screw of an indwelling cephalomedullary nail (CMN). Methods: Pertrochanteric femur fractures were created in 7 synthetic femurs and reconstructed with a CMN. Anteroposterior x-rays were taken with the proximal femur in 0, 15, 30, and 45 degrees of internal/external rotation and 10 and 20 degrees of flexion with neutral rotation. The femoral NSA and the nail angle were measured on anteroposterior x-rays. The corrected NSA was obtained by multiplying the known nail angle by the quotient of the measured NSA over the measured nail angle. Results: With increasing degrees of internal or external rotation, the difference between the actual and the measured NSA increased. After correction using the known angle of the nail, the measured NSA was reduced to within 3 degrees of the actual NSA over all degrees of rotation. At neutral rotation, 15 degrees of external rotation, and 10 and 20 degrees of hip flexion, there was minimal difference between the actual NSA and the measured NSA, negating the effect of the correction formula. Conclusions: The measured NSA after CMN of intertrochanteric fractures is altered by hip rotation. This study validates the correction formula, which determines this difference by using the known angle between the lag screw and the nail.
Does the Angle of the Nail Matter for Pertrochanteric Fracture Reduction? Matching Nail Angle and Native Neck-Shaft Angle
Objectives: To determine whether fixation of pertrochanteric hip fractures with cephalomedullary nails (CMNs) with a neck-shaft angle (NSA) less than the native NSA affects reduction and lag screw cutout. Design: Retrospective comparative study. Setting: Level I trauma center. Patients/Participants: Patients treated with a CMN for unstable pertrochanteric femur fractures (OTA/AO 31-A2.2 and 31-A2.3) between 2005 and 2014. Intervention: CMN fixation. Main Outcome Measurement: NSA reduction and lag screw cutout. Results: Patients fixed with a nail angle less than their native NSA were less likely to have good reductions [17% vs. 60%, 95% confidence interval (CI), −63% to −18%; P = 0.0005], secondary to more varus reductions (41% vs. 10%, 95% CI, 9%–46%; P = 0.01) and more fractures with ≥4 mm of displacement (63% vs. 35%, 95% CI, 3%–49%; P = 0.03). The cutout was not associated with the use of a nail angle less than the native NSA (60% vs. 76%, 95% CI, −56% to 18%; P = 0.5), varus reductions (60% vs. 32%, 95% CI, −13% to 62%; P = 0.3), or poor reductions (20% vs. 17%, 95% CI, −24% to 44%; P = 1.0). Conclusions: The fixation of unstable pertrochanteric hip fractures with a nail angle less than the native NSA was associated with more varus reductions and fracture displacement but did not affect the lag screw cutout. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.