Arthroplasty Complications
Conditions
Keywords
biomaterials, Implant wear, hip arthroplasty, osteolysis, aseptic loosening
Brief summary
Polyethylene wear debris from metal-on-polyethylene articulations are one of the main causes of periprosthetic bone loss and non-infectious loosening in total hip arthroplasty. Ceramic articulations have a very low wear rate when measured in the laboratory and the investigator's hypothesis is that hip arthroplasty with an all ceramic articulation will have less osteolysis and wear in addition to equally good fixation and clinical outcome compared to the same hip arthroplasty design with a metal-on-polyethylene joint.
Interventions
DEVICECeramic-on-ceramic uncemented hip arthroplasty
DEVICEMetal-on-polyethylene uncemented total hip arthroplasty
Sponsors
Stryker Nordic
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Prospective randomized study
Eligibility
Sex/Gender
ALL
Age
35 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* primary osteoarthritis * secondary osteoarthritis caused by idiopathic osteonecrosis, dysplasia or childhood disease (Mb Perthes, epiphysiolysis)
Exclusion criteria
* inflammatory arthritis * hip joint infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Osteolysis size change between 7 and 15 years | Change between 7 and 15 years after surgery | Osteolysis size (cm3) measured with computed tomography |
| Osteolysis frequency change between 7 and 15 years | Change between 7 to 15 years after surgery | Osteolysis frequency (%) measured with computed tomography, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant fixation at 7 years | 7 years after surgery | Stem and cup translation (mm/year) and rotation (degrees/year) measured with radiostereometry |
| Implant fixation at 15 years | At 15 years after surgery | Stem and cup translation (mm/year) and rotation (degrees/year) measured with radiostereometry |
| Articulation wear at 7 years | At 7 years after surgery | Articulation wear as measured with radiostereometry, mm/year |
| Clinical function at 15 years | 15 years after surgery | Harris Hip Score (0-100) |
| Clinical function at 7 years | 7 years after surgery | Harris Hip Score (0-100) |
| Articulation wear at 15 years | 15 years after surgery | Articulation wear as measured with radiostereometry, mm/year |
Outcome results
None listed