Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. (HEMIUNIBIPOL)
Primary Purpose
Hip Fractures
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Unipolar hip hemiarthroplasty
Bipolar hip hemiarthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures focused on measuring Hip, Fracture, Femoral neck, Hemiarthroplasty, Bipolar, Unipolar, Displaced femoral neck fractures
Eligibility Criteria
Inclusion Criteria:
- Displaced femoral neck fracture
- 70 years or older
- Ambulatory status: No walking aids
- No mental illness or impaired cognitive function
Exclusion Criteria:
- Pathological fracture (malignant disease)
- Ongoing systemic or local infection
- Radiologically presence of acetabular wear (osteoarthrosis)
Sites / Locations
- Asker and Baerum Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Unipolar
Bipolar
Arm Description
15 patients randomized for treatment with a unipolar hip hemiarthroplasty
15 patients randomized for treatment with a bipolar hip hemiarthroplasty
Outcomes
Primary Outcome Measures
Acetabular wear measured with radiostereometry
Secondary Outcome Measures
Harris hip score
Health-related quality of life (eq-5d)
Full Information
NCT ID
NCT00746876
First Posted
September 3, 2008
Last Updated
April 18, 2016
Sponsor
Sykehuset Asker og Baerum
Collaborators
Ullevaal University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00746876
Brief Title
Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures.
Acronym
HEMIUNIBIPOL
Official Title
Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. A Randomized Trial of RSA Measurements of Acetabular Wear.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sykehuset Asker og Baerum
Collaborators
Ullevaal University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hemiarthroplasty of the hip is standard treatment of femoral neck fractures (hip fractures). Hemiarthroplasty means replacing the hip joint with a metal prosthesis. Unipolar prostheses has a one-piece design where the hip movement occurs between the prosthesis and the acetabulum (hip socket). A bipolar prosthesis has an additional artificial joint between the two components of the prosthesis. Both treatments are clinically proven and common around the world. No clinical trial has proven benefits of one or the other prosthesis design. The investigators want to measure the differences in acetabular wear using these two prostheses, using radiostereometric measurements.
Detailed Description
Patients 70 years or older presenting to our hospital with an acute femoral neck fracture are eligible for inclusion. 15 patients in each group will be recruited. One group receives a unipolar hemiarthroplasty and 15 receives a bipolar arthroplasty. Tantalum markers are placed around the acetabulum during surgery. Follow-up intervals are at 3, 12 and 24 months with radiostereometric evaluation (radiographs) and clinical evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Hip, Fracture, Femoral neck, Hemiarthroplasty, Bipolar, Unipolar, Displaced femoral neck fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unipolar
Arm Type
Active Comparator
Arm Description
15 patients randomized for treatment with a unipolar hip hemiarthroplasty
Arm Title
Bipolar
Arm Type
Active Comparator
Arm Description
15 patients randomized for treatment with a bipolar hip hemiarthroplasty
Intervention Type
Device
Intervention Name(s)
Unipolar hip hemiarthroplasty
Other Intervention Name(s)
Modular Cathcart Unipolar, DePuy/Johnson and Johnson
Intervention Description
Unipolar hip hemiarthroplasty for the treatment of femoral neck fractures
Intervention Type
Device
Intervention Name(s)
Bipolar hip hemiarthroplasty
Other Intervention Name(s)
Celf-Centering Bipolar, DePuy/Johnson and Johnson
Intervention Description
Bipolar hip hemiarthroplasty for the treatment of femoral neck fractures
Primary Outcome Measure Information:
Title
Acetabular wear measured with radiostereometry
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Harris hip score
Time Frame
24 months
Title
Health-related quality of life (eq-5d)
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Displaced femoral neck fracture
70 years or older
Ambulatory status: No walking aids
No mental illness or impaired cognitive function
Exclusion Criteria:
Pathological fracture (malignant disease)
Ongoing systemic or local infection
Radiologically presence of acetabular wear (osteoarthrosis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asbjørn Hjall, M.D.
Organizational Affiliation
Asker and Baerum hospital, Norway
Official's Role
Study Director
Facility Information:
Facility Name
Asker and Baerum Hospital
City
Baerum
State/Province
Rud
ZIP/Postal Code
1309
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures.
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