Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Hemiarthroplasties (HEMI-RSADEXA)

Ullevaal University Hospital

Status: Unknown

Conditions: Hemiarthroplasty; Acetabular Wear; Femoral Neck Fractures; Bone Density

Treatments: Procedure: Uncemented primary bipolar hemiarthroplasty of the hip; Procedure: Cemented primary bipolar hemiarthroplasty of the hip

Study type: Interventional

Funder types: Other

Identifiers

NCT00607516

HEMI-RSA-DEXA

REK I (Norway) 151-05-04061

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Cognitive dysfunction
• Infection
• Fracture caused by malignant disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Cemented

Active Comparator group

Description:

Cemented primary bipolar hemiarthroplasty of the hip

Treatment:

Procedure: Cemented primary bipolar hemiarthroplasty of the hip

Uncemented

Active Comparator group

Description:

Uncemented primary bipolar hemiarthroplasty of the hip

Treatment:

Procedure: Uncemented primary bipolar hemiarthroplasty of the hip