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

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ClinicalTrials.gov Identifier: NCT01238068
Recruitment Status : Unknown
Verified October 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 10, 2010
Last Update Posted : November 10, 2010
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intertrochanteric Fractures of the Hip Device: gamma nail stryker Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2010
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. hip function score [ Time Frame: 1 year ]
    at the last clinical visit (1 year) the patient will perform hip score testing and record.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238068


Contacts
Contact: ortal segal, MD 972-52-60172 ortal_San@yahoo.com

Locations
Israel
Tel Aviv Medical center Not yet recruiting
Tel Aviv, Israel
Contact: ortal sgal, MD       ortal_San@yahoo.com   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center

Responsible Party: ortal segal, TASMC
ClinicalTrials.gov Identifier: NCT01238068     History of Changes
Other Study ID Numbers: TAMSC-10-OS-10-357-CTIL
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: November 10, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries