Randomized Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Uncemented Total Hip Arthroplasty: A Radiostereometry Study Including 104 Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Arthroplasty Complications
- Sponsor
- Sahlgrenska University Hospital, Sweden
- Enrollment
- 104
- Primary Endpoint
- Osteolysis frequency change between 7 and 15 years
- Last Updated
- 7 years ago
Overview
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.
Investigators
Per-Erik Johanson
Researcher
Sahlgrenska University Hospital, Sweden
Eligibility Criteria
Inclusion Criteria
- •primary osteoarthritis
- •secondary osteoarthritis caused by idiopathic osteonecrosis, dysplasia or childhood disease (Mb Perthes, epiphysiolysis)
Exclusion Criteria
- •inflammatory arthritis
- •hip joint infection
Outcomes
Primary Outcomes
Osteolysis frequency change between 7 and 15 years
Time Frame: Change between 7 to 15 years after surgery
Osteolysis frequency (%) measured with computed tomography,
Osteolysis size change between 7 and 15 years
Time Frame: Change between 7 and 15 years after surgery
Osteolysis size (cm3) measured with computed tomography
Secondary Outcomes
- Clinical function at 7 years(7 years after surgery)
- Articulation wear at 7 years(At 7 years after surgery)
- Articulation wear at 15 years(15 years after surgery)
- Implant fixation at 7 years(7 years after surgery)
- Implant fixation at 15 years(At 15 years after surgery)
- Clinical function at 15 years(15 years after surgery)