Prospective Trial on Trochanteric Femur Fractures Treated With or Without a Trochanter Support Plate (TSP)
Primary Purpose
Femoral Fractures
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Addition of TSP to DHS
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Fractures focused on measuring Trochanter, Femur, Fracture
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of unstable trochanteric femur fracture.(Evans-Jensen class.3-5)
- (can include; Patients with cognitive problems (ie. dementia etc)
Exclusion Criteria:
- Patients with pathological fractures
- Multitrauma patients
- Patients not able to walk before the fracture
- Under 19 years old.
- Patients with fractures needing other treatments than gliding hip screws
- Reverse oblique fractures.
Sites / Locations
- Ortopaedic Department, St.Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
-TSP
+TSP
Arm Description
Patients operated without TSP
Patients operated with TSP
Outcomes
Primary Outcome Measures
Fracture movement postoperatively
Secondary Outcome Measures
Reoperation
Pain postoperatively
Hip function postoperatively
Fracture healing
complications postoperatively
Full Information
NCT ID
NCT00626470
First Posted
February 15, 2008
Last Updated
September 28, 2017
Sponsor
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00626470
Brief Title
Prospective Trial on Trochanteric Femur Fractures Treated With or Without a Trochanter Support Plate
Acronym
TSP
Official Title
A Prospective Randomised Study of Unstable Trochanteric Femur Fractures Treated With Dynamic Hip Screw With and Without a Trochanter Support Plate
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
December 2008 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fractures just below the hip often are treated with a so called Gliding Screw and Plate (DHS). Recently a new additional plate called a Trochanter Support Plate (TSP) which attaches to the DHS has become available which is claimed to give extra support to the fracture. In a prospective randomised study we wish to test the hypothesis that the TSP does not give any additional stability to the fracture treated with the DHS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Fractures
Keywords
Trochanter, Femur, Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
-TSP
Arm Type
Active Comparator
Arm Description
Patients operated without TSP
Arm Title
+TSP
Arm Type
Active Comparator
Arm Description
Patients operated with TSP
Intervention Type
Procedure
Intervention Name(s)
Addition of TSP to DHS
Intervention Description
All patients operated with DHS. Of these two groups. One operated with TSP and one without.
Primary Outcome Measure Information:
Title
Fracture movement postoperatively
Time Frame
One year
Secondary Outcome Measure Information:
Title
Reoperation
Time Frame
One year
Title
Pain postoperatively
Time Frame
one year
Title
Hip function postoperatively
Time Frame
one year
Title
Fracture healing
Time Frame
one year
Title
complications postoperatively
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of unstable trochanteric femur fracture.(Evans-Jensen class.3-5)
(can include; Patients with cognitive problems (ie. dementia etc)
Exclusion Criteria:
Patients with pathological fractures
Multitrauma patients
Patients not able to walk before the fracture
Under 19 years old.
Patients with fractures needing other treatments than gliding hip screws
Reverse oblique fractures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Haddon, MD
Organizational Affiliation
St. Olavs Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ortopaedic Department, St.Olavs Hospital
City
Trondheim
ZIP/Postal Code
7000
Country
Norway
12. IPD Sharing Statement
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Prospective Trial on Trochanteric Femur Fractures Treated With or Without a Trochanter Support Plate
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