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

January 12, 2026 updated by: Fundación Universidad Católica de Valencia San Vicente Mártir

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

686

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • VALÈNCIA
      • Valencia, VALÈNCIA, Spain, 46003
        • School of Medicine and Health Sciences, Valencia Catholic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who received the Gamma nail (288) underwent surgery at the Hospital Clínico Universitario, Valencia (1997-2002). On the other hand, the patients operated upon the InterTAN nail (398) underwent surgery at the Vithas Hospitals Group in Valencia between January 2002 and December 2010.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gamma Nail Group
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.
Device: Fracture fixation with cephalomedullary nails
No differences with the routine surgery for trochanteric fractures
InterTAN Nail Group
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.
Device: Fracture fixation with cephalomedullary nails
No differences with the routine surgery for trochanteric fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant-related complications
Time Frame: 6 months
Incidence of device-related adverse events (e.g., cut-out, varus collapse).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of fracture reduction
Time Frame: Immediately postoperative (within 24 hours)
Satisfactory or unsatisfactory according to Baumgaertner's criteria
Immediately postoperative (within 24 hours)
Cephalic screw placement
Time Frame: Immediately postoperative (within 24 hours)
Position of the lag screw according to Cleveland-Bosworth quadrants
Immediately postoperative (within 24 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2025

Primary Completion (Actual)

January 12, 2026

Study Completion (Actual)

January 12, 2026

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Estimated)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCV/2022-2023/009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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