A Clinical Investigation of the Oxford® Partial Knee System

A Prospective, Non-controlled, Clinical Investigation of the Oxford® Partial Knee System

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00699257

Enrollment

Registered

2008-06-17

Start date

2004-07-31

Completion date

2008-12-31

Last updated

2017-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Partial Knee Arthroplasty, Partial Knee Replacement, Arthritis of Medial Compartment of the Knee, Oxford Knee

Brief summary

The purpose of this prospective data collection is to document the performance and clinical outcomes of the Oxford® Partial Knee System.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Knee Society Score	6 weeks, 3 months, 1 year, 3 years, 5 years
Oxford-12 Self Assessment Form	6 weeks, 3 months, 1 year, 3 years, 5 years

Secondary

Measure	Time frame
Incidence of revisions and removals	Any time

Outcome results