A Clinical Investigation of the Oxford® Partial Knee System

June 19, 2017 updated by: Biomet Orthopedics, LLC

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

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

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

85

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Oxford® Partial Knee System

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of revisions and removals
Time Frame: Any time
Any time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biomet Orthopedics, LLC

Investigators

  • Study Director: Kenneth J Beres, MD, Clinical Research, Biomet Orthopedics, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 13, 2008

First Posted (ESTIMATE)

June 17, 2008

Study Record Updates

Last Update Posted (ACTUAL)

June 21, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Biomet 12380-63

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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