Clinical Trials Directory

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

TypeNameDescription
DEVICEUnipolar hip hemiarthroplastyUnipolar hip hemiarthroplasty for the treatment of femoral neck fractures
DEVICEBipolar hip hemiarthroplastyBipolar 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.