A Clinical Investigation of the Oxford® Partial Knee System

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00699257
• Other study ID #: Biomet 12380-63
• Status: Terminated
• Phase: N/A
• First received: June 13, 2008
• Last updated: June 19, 2017
• Start date: July 2004
• Est. completion date: December 2008

Study information

• Verified date: June 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: December 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biomet Orthopedics, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Score		6 weeks, 3 months, 1 year, 3 years, 5 years
Primary	Oxford-12 Self Assessment Form		6 weeks, 3 months, 1 year, 3 years, 5 years
Secondary	Incidence of revisions and removals		Any time