Hip Replacement in Osteoarthritis Patients
Conditions
Keywords
Radiostereometry, Total Hip Arthroplasty, Stem design
Brief summary
The aim of this study is to further investigate the clinical and radiological importance of design changes in cementless hip prosthesis. The investigators have earlier evaluated the classical Furlong HAC total hip prosthesis and a first design change Furlong Active. Now a further development, Furlong Evolution, is to be evaluated. This prosthesis, furthermore, comes with and without a collar, and the investigators are going to randomize between the two. The investigators hypothesize that the new design will be easier to implant and will present equal or less migration than the older designs which would imply a favourable outcome in the long term. The investigators further hypothesize that the collar play no major part for the long term migration and bone remodelling. We will now do a 10 year follow up of the patients including RSA, DXA and PROMS
Interventions
PROCEDUREStem collar
The stem has two versions, one with and one without a collar. The classical Furlong HAC had a collar.
Sponsors
JRI Orthopaedics Ltd
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Primary osteoarthritis of the hip necessitating primary hip replacement * A femur considered suitable for uncemented fixation of the stem * Biological age \<75 years old at the inclusion time of the study.
Exclusion criteria
* Rheumatoid arthritis * Malignant disease * Severe osteoporosis * Earlier fracture or operation in the hip to be operated on * Peroperative fracture * Ongoing corticosteroid (oral) or immunosuppressive medication * Personal disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiostereometric Analysis (RSA) | The first postoperative day, 14 days, 3 months, 1, 2, 5 and 10 years | This will measure the change in migration (translation and rotation around the x-, y-, and z-axis of the hip) over time. The migration pattern the first 2 years can predict the long term outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dual-energy X-ray absorptiometry (DXA) | 14 days postoperatively and after 1, 5 and 10 years | This will measure the change in bone density around the prosthesis during the first important year. This will tell if there is a bone resorption around the stem or cup. |
| General health questionnaire | Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively | EuroQol (EQ-5D) - a standardized instrument for use as measure of general health outcome over time |
| Hip specific health questionnaire | Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively | Hip disability and Osteoarthritis Outcome Score (HOOS) - this is a hip specific questionnaire that will measure how the operation has affected the patients function and pain situation. |
Countries
Sweden
Outcome results
None listed