A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System
A Prospective, Non-randomized, Multicenter Study of the Oxford® Meniscal Unicompartmental Knee System
2 other identifiers
observational
388
1 country
6
Brief Summary
The purpose of this study is to collect information on complications and survivorship of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2006
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 19, 2007
CompletedFirst Posted
Study publicly available on registry
December 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedApril 21, 2021
April 1, 2021
13.8 years
December 19, 2007
April 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survivorship
Assessment of frequency of Revisions
Annually for 9 years post-op
Secondary Outcomes (1)
Complications
2 Years
Study Arms (1)
Oxford® Meniscal Unicompartmental Knee
Patients with PKA using the Oxford® Meniscal Unicompartmental Knee System
Interventions
Oxford® Meniscal Unicompartmental Knee System is a medial, unicompartmental knee prosthesis containing three components: a femoral component, a tibial component, and a tibial meniscal bearing.
Eligibility Criteria
A Multi-center study conducted in the United States of patients who meet the FDA approved indications for use. The Oxford Meniscal Unicompartmental Knee System is intended for use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee and is intended to be implanted with bone cement.
You may qualify if:
- Patients with one of the following diagnoses in the medial compartment of the knee: Osteoarthritis, Avascular Necrosis
You may not qualify if:
- Patients with Rheumatoid arthritis or other forms of inflammatory joint disease
- Patients with infection, sepsis, and osteomyelitis
- Patients with Osteoporosis, Paget's Disease, Charcot's disease, Osteomalacia, and Severe Osteoporosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Barrington Orthopedic Specialissts
Schaumburg, Illinois, 60195, United States
Joint Implant Surgeons
New Albany, Ohio, 43054, United States
Mid-South Orthopedic Associates
Cordova, Tennessee, 38018, United States
Texas Orthopedic Specialist
Bedford, Texas, 76021, United States
Texas Center for Joint Replacement
Plano, Texas, 75093, United States
Advanced Orthopaedic Centers
Richmond, Virginia, 23294, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kacy Arnold
kacy.arnold@zimmerbiomet.com
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2007
First Posted
December 21, 2007
Study Start
March 1, 2006
Primary Completion
December 31, 2019
Study Completion
March 31, 2021
Last Updated
April 21, 2021
Record last verified: 2021-04