Comparison of Gamma Nail Versus Dynamic Hip Screw for the Treatment of Unstable Intertrochanteric Fractures

Not Applicable

• Conditions: Intertrochanteric Femoral Fractures
• Interventions: Device: Gamma-3 Nail; Device: DHS

• Registration Number: NCT01173744
• Lead Sponsor: Wolfson Medical Center

Brief Summary

The objective of the study is to examine the treatment of unstable Intertrochanteric fractures with the short Gamma nail, compared to the use of the dynamic hip screw (DHS).

This is a prospective study. Sixty patients with unstable Intertrochanteric fractures will be randomized to be treated using either Gamma nail or DHS. The patients will be followed for 12 months. The primary endpoint is the clinical outcome as measured by the Merle d'Aubigne and Postelhip score.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-07
• Study Start: 2010-07
• Study First Submitted: 2010-07-27
• Study First Submitted QC: 2010-07-29
• Study First Posted: 2010-08-02
• Last Update Submitted: 2011-06-16
• Last Update Posted: 2011-06-17
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Acute Intertrochanteric fracture - A1-32 AO/OTA
• Abbreviated mental score >6
• Community ambulator (pre-fracture state)

Exclusion Criteria

• Previous arthritis
• Pathological fracture
• Chronic corticosteroid use
• Concomitant lower extremity fractures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gamma-3 Nail	Gamma-3 Nail	-
DHS	DHS	-

Primary Outcome Measures

Name	Time	Method
Clinical outcome as measured by the Merle d'Aubigne and Postel hip score	1 year

Trial Locations

Locations (1)

E. WOlfson medical center; 🇮🇱 Holon, Israel