Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Hemiarthroplasties

Not Applicable

• Conditions: Femoral Neck Fractures; Bone Density; Acetabular Wear; Hemiarthroplasty
• Interventions: Procedure: Cemented primary bipolar hemiarthroplasty of the hip; Procedure: Uncemented primary bipolar hemiarthroplasty of the hip

• Registration Number: NCT00607516
• Lead Sponsor: Ullevaal University Hospital

Brief Summary

Substudy and continuation of HEMI-SAB-UUS (NCT00491673)

Study on radiostereometric measurements of acetabular wear in bipolar hemiarthroplasties and measurements of periprosthetic bone mineral density in cemented and uncemented hemiarthroplasties in patients with femoral neck fractures.

Null hypothesis: No difference in acetabular wear or in bone mineral density changes between cemented and uncemented hemiarthroplasties

Detailed Description

Patients are randomised to treatment with cemented or uncemented bipolar hemiarthroplasty. 1mm tantalum markers are inserted in the pelvis during surgery. RSA X-rays and DEXA measurements conducted postoperatively, after 3 and 12 months. Follow-up visits and clinical examination at 3 and 12 months.

Study Timeline

• Study Start: 2006-03
• Status Verified: 2007-02
• Study First Submitted: 2008-01-22
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-02-05
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Last Update Submitted: 2009-06-23
• Last Update Posted: 2009-06-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Femoral neck fracture
• 65 years or older
• Able to walk independently

Exclusion Criteria

• Cognitive dysfunction
• Infection
• Fracture caused by malignant disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cemented	Cemented primary bipolar hemiarthroplasty of the hip	Cemented primary bipolar hemiarthroplasty of the hip
Uncemented	Uncemented primary bipolar hemiarthroplasty of the hip	Uncemented primary bipolar hemiarthroplasty of the hip

Primary Outcome Measures

Name	Time	Method
Acetabular wear in mm	1 year
Loss of bone mineral density (BMD)	1 year

Secondary Outcome Measures

Name	Time	Method
Functional outcome including pain (Harris Hip Score)	1 year
Activities Of Daily Living (Barthels ADL-Index)	1 year
Quality Of Life (EQ-5D)	1 year

Trial Locations

Locations (1)

Ullevål University Hospital; 🇳🇴 Oslo, Norway