Back to resultsA Prospective Randomised Multicenter Study Comparing the Sliding Hip Screw and the Intertan Nail in Trochanteric and Subtrochanteric Femoral Fractures
Primary Purpose
Trochanteric and Subtrochanteric Hip Fractures, Treatment With a New Nail or a Sliding Hip Screw
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Intertan
Sponsored by
About this trial
This is an interventional treatment trial for Trochanteric and Subtrochanteric Hip Fractures
Eligibility Criteria
Inclusion Criteria:
- Patients older than 60 years with a trochanteric or subtrochanteric hip fracture.
Exclusion Criteria:
- Patients with pathologic fractures, patients already included with a fracture on the opposite side.
Sites / Locations
- Orthopaedic dep, Haukeland University Hospital
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Intertan
Arm Description
Outcomes
Primary Outcome Measures
Early postoperative pain (VAS)(and functional mobility (TUG-test))
Secondary Outcome Measures
Pain, functional mobility (TUG-test), Harris Hip Score, quality of life (EQ-5D) and complications at discharge from hospital,and at 6 weeks,3 and 12 months postop.
Full Information
NCT ID
NCT00621088
First Posted
February 11, 2008
Last Updated
September 12, 2010
Sponsor
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00621088
Brief Title
A Prospective Randomised Multicenter Study Comparing the Sliding Hip Screw and the Intertan Nail in Trochanteric and Subtrochanteric Femoral Fractures
Official Title
A Prospective Randomised Multicenter Study Comparing the Sliding Hip Screw and the Intertan Nail in Trochanteric and Subtrochanteric Femoral Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Haukeland University Hospital
4. Oversight
5. Study Description
Brief Summary
This is a study to compare the new nail "INTERTAN" with a Sliding Hip Screw in treating a specific group of hipfractures (trochanteric and subtrochanteric fractures).
Are there differences in terms of pain, early and late functional mobility and complications between the to implants (and methods of operation)?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trochanteric and Subtrochanteric Hip Fractures, Treatment With a New Nail or a Sliding Hip Screw
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intertan
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Intertan
Intervention Description
Operations performed either with a Sliding Hip Screw or a nail (Intertan)
Primary Outcome Measure Information:
Title
Early postoperative pain (VAS)(and functional mobility (TUG-test))
Time Frame
1 week postoperative
Secondary Outcome Measure Information:
Title
Pain, functional mobility (TUG-test), Harris Hip Score, quality of life (EQ-5D) and complications at discharge from hospital,and at 6 weeks,3 and 12 months postop.
Time Frame
1 year follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients older than 60 years with a trochanteric or subtrochanteric hip fracture.
Exclusion Criteria:
Patients with pathologic fractures, patients already included with a fracture on the opposite side.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjell Matre, MD
Organizational Affiliation
Orthopaedic Department, Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic dep, Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
A Prospective Randomised Multicenter Study Comparing the Sliding Hip Screw and the Intertan Nail in Trochanteric and Subtrochanteric Femoral Fractures
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