A Clinical Investigation of the Oxford® Partial Knee System (NCT00699257) | Clinical Trial Compass
TerminatedNot Applicable
A Clinical Investigation of the Oxford® Partial Knee System
85 participantsStarted 2004-07
Plain-language summary
The purpose of this prospective data collection is to document the performance and clinical outcomes of the Oxford® Partial Knee System.
Who can participate
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* For use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee. The implant is intended to be implanted with bone cement.
Exclusion Criteria:
* Infection
* Use in the lateral compartment of the knee
* Rheumatoid arthritis or other forms of inflammatory joint disease
* Revision of a failed prosthesis, failed upper tibial osteotomy or post-traumatic arthritis after tibial plateau fracture
* Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device
* Disease or damage to the lateral compartment of the knee
* Uncooperative patient or patient with neurologic disorders who is incapable of following directions
* Osteoporosis
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy, neuromuscular disease
* Incomplete or deficient soft tissue surrounding the knee
* Charcot's disease
* A fixed varus deformity (not passively correctable) of greater than 15 degrees
* A flexion deformity greater than 15 degrees
What they're measuring
1
Knee Society Score
Timeframe: 6 weeks, 3 months, 1 year, 3 years, 5 years
2
Oxford-12 Self Assessment Form
Timeframe: 6 weeks, 3 months, 1 year, 3 years, 5 years