Avascular Necrosis, Osteoarthritis
Conditions
Keywords
Unicompartmental Knee, Partial Knee, Knee arthroplasty
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.
Detailed description
Study Objective To provide a prospective 2-year post-operative evaluation of complications and 9-year long-term survivorship analysis of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States. Study Design The study is designed as a prospective, multi-center, non-randomized post approval study. There are two phases to this study: 1. A complications study where patients will be followed for at least 2 years to record all complications that may occur, and 2. A survival study that will record at yearly intervals out to 9 years whether or not the device is still in place or if it has been removed for any reason. Phase 1 requires clinical follow-up (0-2 year) and patients will be evaluated at pre-defined intervals up to 2 years post-operative. Information gathered in phase 1 includes all adverse events and survival data. Phase 2 (3-9 year) only gathers survival data through patient directed mailing and/or phone call.
Interventions
DEVICEOxford® Meniscal Unicompartmental Knee System
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.
Sponsors
Biomet Orthopedics, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with one of the following diagnoses in the medial compartment of the knee: Osteoarthritis, Avascular Necrosis
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship | Annually for 9 years post-op | Assessment of frequency of Revisions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 2 Years | Patients will be followed for at least 2 years to record all complications that may occur |
Countries
United States
Outcome results
None listed