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

NCT ID: NCT01173744

Last Updated: 2011-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intertrochanteric Femoral Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Gamma-3 Nail

Group Type EXPERIMENTAL

Gamma-3 Nail

Intervention Type DEVICE

Gamma-3 Nail (stryker)

DHS

Group Type ACTIVE_COMPARATOR

DHS

Intervention Type DEVICE

DHS (Zimmer)

Interventions

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Gamma-3 Nail

Gamma-3 Nail (stryker)

Intervention Type DEVICE

DHS

DHS (Zimmer)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Wolfson MC

Locations

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E. WOlfson medical center

Holon, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Dror Lakstein, MD

Role: CONTACT

++972-3-5028383

Facility Contacts

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Dror Lakstein, MD

Role: primary

++972-3-5028383

Other Identifiers

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0076-10-WOMC

Identifier Type: -

Identifier Source: org_study_id

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