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

Intertrochanteric Femoral Fractures Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01173744
• Other study ID #: 0076-10-WOMC
• Status: Recruiting
• Phase: N/A
• First received: July 27, 2010
• Last updated: June 16, 2011
• Start date: July 2010
• Est. completion date: July 2012

Study information

• Verified date: July 2010
• Source: Wolfson Medical Center
• Contact: Dror Lakstein, MD
• Phone: ++972-3-5028383
• Email: drorale[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Intertrochanteric Femoral Fractures

Intervention

Device:
• Gamma-3 Nail
Gamma-3 Nail (stryker)
• DHS
DHS (Zimmer)

Locations

Country	Name	City	State
Israel	E. WOlfson medical center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcome as measured by the Merle d'Aubigne and Postel hip score		1 year	No