Osteoarthritis
Conditions
Keywords
Short femoral stem, Stress shielding, Stem migration, Implant Survival, DEXA, Radiostereometric analysis
Brief summary
This evaluation is conducted to evaluate the safety and performance of two different stem lengths of the Taperloc Total Hip System. Per implant bone loss and migration of the stem are compared between the two groups with Dual-energy X-ray absorptiometry (DEXA) and radiostereomektric analysis
Detailed description
Consecutive patients between 50 - 70 years diagnosed with primary osteoarthritis of the hip and eligible for total hip arthroplasty will be asked to participate in the study. Periprosthetic bone loss, migration of the components and clinical scores will be recorded prospectively at 3,6,12 and 24 months.
Interventions
DEVICETaperloc Microplasty
primary total hip arthroplasty
DEVICETaperloc standard
primary total hip arthroplasty
Sponsors
Biomet U.K. Ltd.
Ingemar Ivarsson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with primary osteoarthritis of the hip scheduled for THA. * Suitable anatomy for both stems * Willingness and ability to follow study-protocol
Exclusion criteria
* Malignancy or metastatic bone disease. * Any other disease severely affecting bone and mineral metabolism * Ongoing or previous treatment (within 5 years prior to inclusion) with steroids * Ongoing or previous treatment (within 5 years prior to inclusion) with antiresorptives. * Ongoing or previous treatment (within 5 years prior to inclusion) with immunosuppressive drugs. * Ongoing or previous treatment (within 5 years prior to inclusion) with anticonvulsive therapy. * Ongoing or previous treatment (within 5 years prior to inclusion) with hormonal therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA) [ Time Frame: | bone mineral density (BMD) measured postoperatively at 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis | 2 years |
Other
| Measure | Time frame |
|---|---|
| Clinical outcome measures with Harris Hip Score comparing patients receiving different stems. | 3, 6, 12 and 24 months |
| Clinical outcome measures with Womac Score comparing patients receiving different stems. | 3, 6, 12 and 24 months |
Countries
Sweden
Outcome results
None listed