Cementless Oxford Partial Knee Retrospective and Prospective Controlled Multi-center Observational Study

Zimmer Biomet0 sites391 target enrollmentNovember 2014

ConditionsOsteoarthritis Avascular Necrosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Zimmer Biomet
Enrollment: 391
Primary Endpoint: Composite Endpoint- Safety & Efficacy (Radiographic Success, American Knee Society Score, Absence of Revision / Removal / Unanticipated Adverse Device Affects)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

April 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Zimmer Biomet

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Composite Endpoint- Safety & Efficacy (Radiographic Success, American Knee Society Score, Absence of Revision / Removal / Unanticipated Adverse Device Affects)

Time Frame: 22+months

Radiographic Success, American Knee Society Score, Absence of Revision / Removal / Unanticipated Adverse Device Affects