Trials / Completed
CompletedNCT00746876
Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures.
Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. A Randomized Trial of RSA Measurements of Acetabular Wear.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Sykehuset Asker og Baerum · Academic / Other
- Sex
- All
- Age
- 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Unipolar hip hemiarthroplasty | Unipolar hip hemiarthroplasty for the treatment of femoral neck fractures |
| DEVICE | Bipolar hip hemiarthroplasty | Bipolar hip hemiarthroplasty for the treatment of femoral neck fractures |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2012-12-01
- Completion
- 2015-12-01
- First posted
- 2008-09-04
- Last updated
- 2016-04-19
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT00746876. Inclusion in this directory is not an endorsement.