Back to resultsComparison of Gamma Nail Versus Dynamic Hip Screw for the Treatment of Unstable Intertrochanteric Fractures
Primary Purpose
Intertrochanteric Femoral Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Gamma-3 Nail
DHS
Sponsored by
About this trial
This is an interventional treatment trial for Intertrochanteric Femoral Fractures focused on measuring Intertrochanteric femoral fractures - unstable
Eligibility 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
Sites / Locations
- E. WOlfson medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Gamma-3 Nail
DHS
Arm Description
Outcomes
Primary Outcome Measures
Clinical outcome as measured by the Merle d'Aubigne and Postel hip score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01173744
Brief Title
Comparison of Gamma Nail Versus Dynamic Hip Screw for the Treatment of Unstable Intertrochanteric Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Wolfson Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intertrochanteric Femoral Fractures
Keywords
Intertrochanteric femoral fractures - unstable
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gamma-3 Nail
Arm Type
Experimental
Arm Title
DHS
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Gamma-3 Nail
Intervention Description
Gamma-3 Nail (stryker)
Intervention Type
Device
Intervention Name(s)
DHS
Intervention Description
DHS (Zimmer)
Primary Outcome Measure Information:
Title
Clinical outcome as measured by the Merle d'Aubigne and Postel hip score
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dror Lakstein, MD
Phone
++972-3-5028383
Email
drorale@gmail.com
Facility Information:
Facility Name
E. WOlfson medical center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dror Lakstein, MD
Phone
++972-3-5028383
Email
drorale@gmail.com
First Name & Middle Initial & Last Name & Degree
Dror Lakstein, MD
12. IPD Sharing Statement
Learn more about this trial
Comparison of Gamma Nail Versus Dynamic Hip Screw for the Treatment of Unstable Intertrochanteric Fractures
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