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

November 9, 2010 updated by: Tel-Aviv Sourasky Medical Center
The study hypothesis is the the results of the use of Gamma nail will be superior to the use of Dynamic hip screw for unstable intertrochantric hip fracture.

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
      • Tel Aviv, Israel
        • Tel Aviv Medical Center

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients diagozied with acute intertrochantric unstable fracture
  • a minimum minimental score of 6
  • ability to walk 500 meters indepedently

Exclusion Criteria:

  • pathological fracture
  • multiple fractures
  • neurological conditions

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: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Gamma nail, fracture stabilization, better walking
Device: gamma nail stryker
for acute unstable pertrochantric fractures the subjects will be treated randomaly with either Gamma nail device Vs Dynamic hip screw

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hip function score
Time Frame: 1 year
at the last clinical visit (1 year) the patient will perform hip score testing and record.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
x-ray, surgical outcome
Time Frame: 1 year
in the last clincial visit x ray finding will be record and the overall surgical outcome (infection, bleeding etc.) will be record
1 year

Collaborators and Investigators

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

Sponsor

Tel-Aviv Sourasky Medical Center

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

November 1, 2010

Primary Completion (ANTICIPATED)

November 1, 2011

Study Completion (ANTICIPATED)

November 1, 2011

Study Registration Dates

First Submitted

October 26, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (ESTIMATE)

November 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 10, 2010

Last Update Submitted That Met QC Criteria

November 9, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAMSC-10-OS-10-357-CTIL

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.

Clinical Trials on Intertrochanteric Fractures of the Hip

Clinical Trials on gamma nail stryker

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe