Avascular Necrosis, Osteoarthritis
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the Cementless Oxford Partial Knee System.
Detailed description
The study is designed to document and compare the clinical and radiographic results of the Cementless Oxford Partial Knee System (investigational device) to those of the cemented Oxford Partial Knee System (control device).
Interventions
None listed
Sponsors
Zimmer Biomet
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* have primary diagnosis of osteoarthritis or avascular necrosis limited to the medial compartment of the knee * signed informed consent for patients contributing to investigational or control if required * Male or female over the age of 21 years at the time of surgery * Undergone primary partial knee arthroplasty as unilateral arthroplasty or bilateral arthroplasty, simultaneously or otherwise * Patients that are current residents of the United Kingdom
Exclusion criteria
* Evidence of infection, sepsis, and osteomyelitis at the time of surgery * 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 * Partial or full thickness cartilage disease or damage to central part of the lateral femoral condyle * Osteoporosis or insufficient bone stock * Metabolic disorders which may impair bone formation * Osteomalacia * Distant foci of infection 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 * Refuse to sign informed consent if it is required * Patients that are not current residents of the United Kingdom
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Endpoint- Safety & Efficacy (Radiographic Success, American Knee Society Score, Absence of Revision / Removal / Unanticipated Adverse Device Affects) | 22+months | Radiographic Success, American Knee Society Score, Absence of Revision / Removal / Unanticipated Adverse Device Affects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship (Cementless Only) | 22+ Months | Minimum 1,000 cases to assess survivorship of cementless components |
| American Knee Society Score | 0-16 Week, 6 Month, 12 Month | Assessment of Function and Range of Motion; retrospective study- data will be collected if available |
| Oxford Knee Score | 0-16 Weeks, 6 Months, 12 Months, 22+ Months | Retrospective study; data will be collected if available. |
| Adverse Events | Through 22+ Months Postop | — |
Outcome results
None listed