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OpenTrials
Completed

NCT Number: NCT07282236

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

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.

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Key information

Conditions

Unstable Throchanteric Hip Fractures Pertrochanteric Fracture of Femur

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

School of Medicine and Health Sciences, Valencia Catholic University

Valencia, VALÈNCIA, 46003, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fracture fixation with cephalomedullary nails

Device

No differences with the routine surgery for trochanteric fractures

Primary outcomes

  1. Implant-related complications

    Time frame: 6 months

    Incidence of device-related adverse events (e.g., cut-out, varus collapse).

Secondary outcomes

  1. Quality of fracture reduction

    Time frame: Immediately postoperative (within 24 hours)

    Satisfactory or unsatisfactory according to Baumgaertner's criteria

  2. Cephalic screw placement

    Time frame: Immediately postoperative (within 24 hours)

    Position of the lag screw according to Cleveland-Bosworth quadrants

Sponsors and collaborators

Lead sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2025
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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