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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07282236
Enrollment
686
Registered
2025-12-15
Start date
2025-12-13
Completion date
2026-01-12
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pertrochanteric Fracture of Femur, Unstable Throchanteric Hip Fractures

Keywords

Throchanteric Fractures; Gamma nail; InterTAN nail

Brief 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

Interventions

DEVICEFracture fixation with cephalomedullary nails

No differences with the routine surgery for trochanteric fractures

Sponsors

Fundación Universidad Católica de Valencia San Vicente Mártir
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Implant-related complications6 monthsIncidence of device-related adverse events (e.g., cut-out, varus collapse).

Secondary

MeasureTime frameDescription
Quality of fracture reductionImmediately postoperative (within 24 hours)Satisfactory or unsatisfactory according to Baumgaertner's criteria
Cephalic screw placementImmediately postoperative (within 24 hours)Position of the lag screw according to Cleveland-Bosworth quadrants

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026