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

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ClinicalTrials.gov Identifier: NCT01173744
Recruitment Status : Unknown
Verified July 2010 by Wolfson Medical Center.
Recruitment status was:  Recruiting
First Posted : August 2, 2010
Last Update Posted : June 17, 2011
Sponsor:
Information provided by:
Wolfson Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Intertrochanteric Femoral Fractures Device: Gamma-3 Nail Device: DHS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : July 2010
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Gamma-3 Nail Device: Gamma-3 Nail
Gamma-3 Nail (stryker)
Active Comparator: DHS Device: DHS
DHS (Zimmer)



Primary Outcome Measures :
  1. Clinical outcome as measured by the Merle d'Aubigne and Postel hip score [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01173744


Contacts
Contact: Dror Lakstein, MD ++972-3-5028383 drorale@gmail.com

Locations
Israel
E. WOlfson medical center Recruiting
Holon, Israel, 58100
Contact: Dror Lakstein, MD    ++972-3-5028383    drorale@gmail.com   
Principal Investigator: Dror Lakstein, MD         
Sponsors and Collaborators
Wolfson Medical Center

Responsible Party: Dror Lakstein, MD, Wolfson MC
ClinicalTrials.gov Identifier: NCT01173744     History of Changes
Other Study ID Numbers: 0076-10-WOMC
First Posted: August 2, 2010    Key Record Dates
Last Update Posted: June 17, 2011
Last Verified: July 2010

Keywords provided by Wolfson Medical Center:
Intertrochanteric femoral fractures - unstable

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