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

Fundación Universidad Católica de Valencia San Vicente Mártir

Status: Completed

Conditions: Unstable Throchanteric Hip Fractures; Pertrochanteric Fracture of Femur

Treatments: Device: Fracture fixation with cephalomedullary nails

Study type: Observational

Funder types: Other

Identifiers

NCT07282236

UCV/2022-2023/009

Details and patient eligibility

About

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.

Full 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

Enrollment: 686 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unstable trochanteric fractures confirmed radiographically according to OTA (Orthopedic Trauma Association), treated with Gamma or InterTAN nail,
• available follow-up for ≥ 6 months

Exclusion criteria

• Pathological fractures
• Polytrauma precluding standard treatment/follow-up
• Missing key variables/outcomes

Trial design

686 participants in 2 patient groups

Gamma Nail Group

Description:

The Gamma Nail Group consists of patients diagnosed with unstable trochanteric fractures who underwent surgical management using a Gamma cephalomedullary nail. This intervention involves internal fixation with a short or long intramedullary device designed to provide stable biomechanical support for unstable peritrochanteric fracture patterns. Patients in this group received the Gamma nail as the primary method of fracture stabilization, with the goal of achieving early mobilization, maintaining fracture alignment, and reducing the risk of mechanical complication.

Treatment:

Device: Fracture fixation with cephalomedullary nails

InterTAN Nail Group

Description:

The InterTAN Nail Group includes patients with unstable trochanteric fractures who were treated surgically using an InterTAN cephalomedullary nail. This intervention consists of internal fixation with a dual integrated screw intramedullary device designed to enhance rotational and axial stability in unstable peritrochanteric fracture patterns. Patients in this group received the InterTAN nail as the primary method of fracture stabilization, aiming to improve construct rigidity, facilitate early mobilization, and support optimal fracture healing.

Treatment:

Device: Fracture fixation with cephalomedullary nails