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

June 16, 2011 updated by: Wolfson Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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

  • Israel
      • Holon, Israel, 58100
        • Recruiting
        • E. Wolfson Medical Center
        • Principal Investigator:
          • Dror Lakstein, MD

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

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Gamma-3 Nail
Device: Gamma-3 Nail
Gamma-3 Nail (stryker)
ACTIVE_COMPARATOR: DHS
Device: DHS
DHS (Zimmer)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical outcome as measured by the Merle d'Aubigne and Postel hip score
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Wolfson Medical Center

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

July 1, 2010

Primary Completion (ANTICIPATED)

July 1, 2012

Study Completion (ANTICIPATED)

July 1, 2012

Study Registration Dates

First Submitted

July 27, 2010

First Submitted That Met QC Criteria

July 29, 2010

First Posted (ESTIMATE)

August 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 17, 2011

Last Update Submitted That Met QC Criteria

June 16, 2011

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0076-10-WOMC

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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