Osteoarthritis
Conditions
Brief summary
The primary objective of this project is to investigate, using RSA, acetabular implant migration of the OsseoTi™ G7 acetabular cup in comparison to conventional PPS coated G7 acetabular cup, and compare liner wear of thinnest available E1™ liner, allowing for the largest possible femoral head (36mm-44mm) to E1™ liner holding a 32mm femoral head in the G7 acetabular system with endpoint assessment being performed at the 2 year follow-up.
Interventions
DEVICETHA with G7 PPS coted acetabular component
DEVICETHA with G7 OsseoTi coted acetabular component
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* • Participants with primary hip osteoarthritis set to receive a primary unilateral uncemented total hip arthroplasty. * Participants must be 18-75 years of age. * Participants must be able to speak and understand Danish (or depending on country where patient is enrolled). * Participants must be able to give informed consent and be cognitively intact. * Participants must be expected to be able to complete all postoperative controls. * Participants must not have severe comorbidities, ASA-score ≤ 3.
Exclusion criteria
* Terminal illness. * Rheumatoid arthritis. * Previous fracture of the hip. * Osteonecrosis of the hip. * Previous infection of the hip. * Severe bony deformity warranting the use of non-standard implants. * Metastasis in the periarticular bone or proximal femur. * Female patients that are pregnant or planning pregnancy during follow-up period * If bone stock or femoral canal type, assessed on preoperative x-ray, warrants the use of cemented fixation. * Documented osteoporosis with patient in active medical treatment. * Comorbidity with altered pain perception (e.g. DM with neuropathy). * Participants that develop deep infection in the follow-up period are excluded from the project.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RSA migration in 3 dimentions of the acetabular components as measured by Radiostereometric analysis, RSA. | 2 year | Radiostereometric analysis, RSA, is an accurate technique for measuring small relative motions from sequential sets of radiographs over time and has been used to measure polyethylene wear and implant migration. Measurements are performed in microns. |
Countries
Denmark, Sweden
Outcome results
None listed