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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Wolfson Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01173744
First received: July 27, 2010
Last updated: June 16, 2011
Last verified: July 2010
  Purpose

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 Intervention
Intertrochanteric Femoral Fractures
Device: Gamma-3 Nail
Device: DHS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • Clinical outcome as measured by the Merle d'Aubigne and Postel hip score [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gamma-3 Nail Device: Gamma-3 Nail
Gamma-3 Nail (stryker)
Active Comparator: DHS Device: DHS
DHS (Zimmer)

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dror Lakstein, MD, Wolfson MC
ClinicalTrials.gov Identifier: NCT01173744     History of Changes
Other Study ID Numbers: 0076-10-WOMC
Study First Received: July 27, 2010
Last Updated: June 16, 2011
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 22, 2014