NCT07282236

Retrospective Comparative Outcomes of Gamma and InterTAN Nail for Unstable Intertrochanteric Hip Fractures

Quality of Reduction, Position of the Lag Screw and Mechanical Complications in Unstable Interthrochanteric Hip Fractures. A Comparison Between Gamma and InterTAN Nail.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 686 (actual)
• Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Objective: compare outcomes of unstable intertrochanteric hip fractures treated with two commercially available implants. Design: retrospective observational cohort of 288 treated with a Gamma® nail and 398 with an InterTAN® nail. Patients were operated between 1997 and 2010. Primary outcomes: satisfactory reduction, optimal cephalic screw placement, and to evaluate the incidence of mechanical complications; secondary measures included the tip-apex distance (TAD), hematocrit (Hto) and hemoglobin (Hb) drop, transfusion requirement and volume, hospital length of stay and the time to first ambulation.

Detailed description

Rationale: to evaluate whether outcomes differ between two commonly used cephalomedullary nails for unstable intertrochanteric hip fractures in routine practice. Setting: double-centre, single-city retrospective cohort with consecutive patients treated by the same surgeon-Gamma2® at the Hospital Clínico Universitario (1997-2002; n=288) and InterTAN® at Vithas Hospitals (2002-2010; n=398). Cohorts: defined by the implant used in usual care; adults ≥65 years with unstable AO/OTA A2-A3 patterns were included; key exclusions were stable patterns, pathologic fractures, subtrochanteric extension, poor radiographs, and \<6-month follow-up. Planned analyses: between-group comparisons of reoperation and implant-related complications (primary focus), plus perioperative and functional parameters, using χ²/t-tests as appropriate adjusting for age, sex, ASA class, AO/OTA pattern, reduction quality, and screw position metrics (e.g., TAD); results reported as effect sizes with 95% CIs, with sensitivity analyses by fracture pattern and reduction quality

Conditions

• Unstable Throchanteric Hip Fractures
• Pertrochanteric Fracture of Femur

Interventions

Type	Name	Description
DEVICE	Fracture fixation with cephalomedullary nails	No differences with the routine surgery for trochanteric fractures

Timeline

• Start date: 2025-12-13
• Primary completion: 2026-01-12
• Completion: 2026-01-12
• First posted: 2025-12-15
• Last updated: 2026-01-13

Locations

1 site across 1 country: Spain