Acetabular Wear, Bone Density, Femoral Neck Fractures, Hemiarthroplasty
Conditions
Keywords
fracture, arthroplasty, wear, osteoporosis, bone
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.
Interventions
Cemented primary bipolar hemiarthroplasty of the hip
Uncemented primary bipolar hemiarthroplasty of the hip
Sponsors
Ullevaal University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Femoral neck fracture * 65 years or older * Able to walk independently
Exclusion criteria
* Cognitive dysfunction * Infection * Fracture caused by malignant disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acetabular wear in mm | 1 year |
| Loss of bone mineral density (BMD) | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Norway
Outcome results
None listed