A Clinical Investigation of the Oxford® Partial Knee System
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Phase: N/A
Status: Enrolling by invitation
Sponsored by: Biomet Orthopedics, Inc. Official(s) and/or principal investigator(s):
Kenneth J Beres, MD, Study Director, Affiliation: Clinical Research, Biomet Orthopedics, Inc
Summary
The purpose of this prospective data collection is to document the performance and clinical
outcomes of the Oxford® Partial Knee System.
Clinical Details
Official title: A Prospective, Non-Controlled, Clinical Investigation of the Oxford® Partial Knee System
Study design: Cohort, Prospective
Primary outcome: Knee Society ScoreOxford-12 Self Assessment Form
Secondary outcome: Incidence of revisions and removals
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: July 2004
Ending date: June 2014
Last updated: June 13, 2008
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