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

Primary Purpose

Intertrochanteric Fractures of the Hip

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
gamma nail stryker
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intertrochanteric Fractures of the Hip

Eligibility Criteria

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

Inclusion Criteria:

  • patients diagozied with acute intertrochantric unstable fracture
  • a minimum minimental score of 6
  • ability to walk 500 meters indepedently

Exclusion Criteria:

  • pathological fracture
  • multiple fractures
  • neurological conditions

Sites / Locations

  • Tel Aviv Medical center

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Gamma nail, fracture stabilization, better walking

Arm Description

Outcomes

Primary Outcome Measures

hip function score
at the last clinical visit (1 year) the patient will perform hip score testing and record.

Secondary Outcome Measures

x-ray, surgical outcome
in the last clincial visit x ray finding will be record and the overall surgical outcome (infection, bleeding etc.) will be record

Full Information

First Posted
October 26, 2010
Last Updated
November 9, 2010
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01238068
Brief Title
Comparison of the Results of Treatment by Gamma Nail Versus Dynamic Hip Screw for Unstable Intertrochanteric Hip Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

5. Study Description

Brief Summary
The study hypothesis is the the results of the use of Gamma nail will be superior to the use of Dynamic hip screw for unstable intertrochantric hip fracture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intertrochanteric Fractures of the Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gamma nail, fracture stabilization, better walking
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
gamma nail stryker
Intervention Description
for acute unstable pertrochantric fractures the subjects will be treated randomaly with either Gamma nail device Vs Dynamic hip screw
Primary Outcome Measure Information:
Title
hip function score
Description
at the last clinical visit (1 year) the patient will perform hip score testing and record.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
x-ray, surgical outcome
Description
in the last clincial visit x ray finding will be record and the overall surgical outcome (infection, bleeding etc.) will be record
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients diagozied with acute intertrochantric unstable fracture a minimum minimental score of 6 ability to walk 500 meters indepedently Exclusion Criteria: pathological fracture multiple fractures neurological conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ortal segal, MD
Phone
972-52-60172
Email
ortal_San@yahoo.com
Facility Information:
Facility Name
Tel Aviv Medical center
City
Tel Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ortal sgal, MD
Email
ortal_San@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
35080771
Citation
Lewis SR, Macey R, Gill JR, Parker MJ, Griffin XL. Cephalomedullary nails versus extramedullary implants for extracapsular hip fractures in older adults. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD000093. doi: 10.1002/14651858.CD000093.pub6.
Results Reference
derived

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

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