Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures.

Not Applicable

Completed

• Conditions: Hip Fractures
• Interventions: Device: Unipolar hip hemiarthroplasty; Device: Bipolar hip hemiarthroplasty

• Registration Number: NCT00746876
• Lead Sponsor: Sykehuset Asker og Baerum

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.

Study Timeline

• Study First Submitted: 2008-09-03
• Study First Submitted QC: 2008-09-03
• Study First Posted: 2008-09-04
• Study Start: 2009-09
• Primary Completion: 2012-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unipolar	Unipolar hip hemiarthroplasty	15 patients randomized for treatment with a unipolar hip hemiarthroplasty
Bipolar	Bipolar hip hemiarthroplasty	15 patients randomized for treatment with a bipolar hip hemiarthroplasty

Primary Outcome Measures

Name	Time	Method
Acetabular wear measured with radiostereometry	24 months

Secondary Outcome Measures

Name	Time	Method
Harris hip score	24 months
Health-related quality of life (eq-5d)	24 months

Trial Locations

Locations (1)

Asker and Baerum Hospital; 🇳🇴 Baerum, Rud, Norway