A Clinical Investigation of the Oxford® Partial Knee System

NCT00699257 | Terminated

• 1 other identifier: Biomet 12380-63
• Study Type: observational
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osteoarthritis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of revisions and removals

  Any time

Study Arms (1)

Oxford® Partial Knee System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that have already made the decision to undergo knee surgery and will receive the Oxford® Partial Knee System.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biomet Orthopedics, LLC: lead

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kenneth J Beres, MD

  Clinical Research, Biomet Orthopedics, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: July 1, 2004
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 21, 2017

Record last verified: 2017-06