A Clinical Investigation of the Oxford® Partial Knee System

NCT ID: NCT00699257

Last Updated: 2017-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-07-31

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Oxford® Partial Knee System

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biomet Orthopedics, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth J Beres, MD

Role: STUDY_DIRECTOR

Clinical Research, Biomet Orthopedics, LLC

Other Identifiers

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Biomet 12380-63

Identifier Type: -

Identifier Source: org_study_id

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