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Comparison Between Gamma 3 Nail and ACE Trochanteric Nail

Primary Purpose

Pertrochanteric and Subtrochanteric Femur Fractures

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Gamma 3 nail versus ACE trochanteric nail
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pertrochanteric and Subtrochanteric Femur Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Pertrochanteric or subtrochanteric femur fracture

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with a Gamma 3 nail.

Arm Description

Outcomes

Primary Outcome Measures

Consolidation of the fracture

Secondary Outcome Measures

Full Information

First Posted
August 21, 2006
Last Updated
December 15, 2022
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT00367406
Brief Title
Comparison Between Gamma 3 Nail and ACE Trochanteric Nail
Official Title
Comparison Between Gamma 3 Nail and ACE Trochanteric Nail
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2006 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Pertrochanteric and subtrochanteric femur fractures will be treated with a Gamma 3 nail or an ACE Trochanteric nail. Following topics will be assessed: fracture consolidation, mobility, pain, walking power, agility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pertrochanteric and Subtrochanteric Femur Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with a Gamma 3 nail.
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Gamma 3 nail versus ACE trochanteric nail
Intervention Description
Comparing Gamma 3 nail versus ACE trochanteric nail
Primary Outcome Measure Information:
Title
Consolidation of the fracture
Time Frame
From surgery untill healing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pertrochanteric or subtrochanteric femur fracture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
René Verdonk, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent

Learn more about this trial

Comparison Between Gamma 3 Nail and ACE Trochanteric Nail

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