Cementless Oxford Partial Knee Controlled Observational Study

Completed

• Conditions: Osteoarthritis; Avascular Necrosis

• Registration Number: NCT02350049
• Lead Sponsor: Zimmer Biomet

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).

Study Timeline

• Study First Submitted: 2014-07-15
• Study Start: 2014-11
• Study First Submitted QC: 2015-01-28
• Study First Posted: 2015-01-29
• Primary Completion: 2016-03
• Study Completion: 2017-04
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 391

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Survivorship (Cementless Only)	22+ Months	Minimum 1,000 cases to assess survivorship of cementless components
Oxford Knee Score	0-16 Weeks, 6 Months, 12 Months, 22+ Months	Retrospective study; data will be collected if available.
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
Adverse Events	Through 22+ Months Postop