Overview

This trial is active, not recruiting.

Conditions femoral neck fractures, bone density, acetabular wear, hemiarthroplasty
Treatments cemented primary bipolar hemiarthroplasty of the hip, uncemented primary bipolar hemiarthroplasty of the hip
Sponsor Ullevaal University Hospital
Start date March 2006
End date January 2009
Trial size 22 participants
Trial identifier NCT00607516, HEMI-RSA-DEXA, REK I (Norway) 151-05-04061

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Cemented primary bipolar hemiarthroplasty of the hip
cemented primary bipolar hemiarthroplasty of the hip Spectron, Smith & Nephew, Memphis, TN
Cemented primary bipolar hemiarthroplasty of the hip
(Active Comparator)
Uncemented primary bipolar hemiarthroplasty of the hip
uncemented primary bipolar hemiarthroplasty of the hip Corail, DePuy/Johnson and Johnson, United Kingdom
Uncemented primary bipolar hemiarthroplasty of the hip

Primary Outcomes

Measure
Acetabular wear in mm
time frame: 1 year
Loss of bone mineral density (BMD)
time frame: 1 year

Secondary Outcomes

Measure
Functional outcome including pain (Harris Hip Score)
time frame: 1 year
Activities Of Daily Living (Barthels ADL-Index)
time frame: 1 year
Quality Of Life (EQ-5D)
time frame: 1 year

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: - Femoral neck fracture - 65 years or older - Able to walk independently Exclusion Criteria: - Cognitive dysfunction - Infection - Fracture caused by malignant disease

Additional Information

Official title Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Cemented and Uncemented Hemiarthroplasties for Femoral Neck Fractures
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2009.
Information provided to ClinicalTrials.gov by Ullevaal University Hospital.