Femoral Neck Fractures Clinical Trial
— HEMI-RSADEXAOfficial title:
Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Cemented and Uncemented Hemiarthroplasties for Femoral Neck Fractures
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
Status | Active, not recruiting |
Enrollment | 22 |
Est. completion date | January 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Femoral neck fracture - 65 years or older - Able to walk independently Exclusion Criteria: - Cognitive dysfunction - Infection - Fracture caused by malignant disease |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Ullevål University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Ullevaal University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acetabular wear in mm | 1 year | No | |
Primary | Loss of bone mineral density (BMD) | 1 year | No | |
Secondary | Functional outcome including pain (Harris Hip Score) | 1 year | No | |
Secondary | Activities Of Daily Living (Barthels ADL-Index) | 1 year | No | |
Secondary | Quality Of Life (EQ-5D) | 1 year | No |
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