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
Recruitment status was Recruiting
Sponsor:
Wolfson Medical Center
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01173744
First received: July 27, 2010
Last updated: June 16, 2011
Last verified: July 2010
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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
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 May 19, 2013