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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01238068
First received: October 26, 2010
Last updated: November 9, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Intervention
Intertrochanteric Fractures of the Hip
 Device: gamma nail stryker

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • hip function score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    at the last clinical visit (1 year) the patient will perform hip score testing and record.


Secondary Outcome Measures:
  • x-ray, surgical outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    in the last clincial visit x ray finding will be record and the overall surgical outcome (infection, bleeding etc.) will be record


Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: ortal segal, TASMC
ClinicalTrials.gov Identifier: NCT01238068     History of Changes
Other Study ID Numbers: TAMSC-10-OS-10-357-CTIL
Study First Received: October 26, 2010
Last Updated: November 9, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013