A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System
|Osteoarthritis Avascular Necrosis||Device: Oxford® Meniscal Unicompartmental Knee System|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective, Non-randomized, Multicenter Study of the Oxford® Meniscal Unicompartmental Knee System|
- Survivorship [ Time Frame: Annually for 9 years post-op ]Assessment of frequency of Revisions
- Complications [ Time Frame: 2 Years ]Patients will be followed for at least 2 years to record all complications that may occur
|Study Start Date:||March 2006|
|Estimated Study Completion Date:||June 2019|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Oxford® Meniscal Unicompartmental Knee
Patients with PKA using the Oxford® Meniscal Unicompartmental Knee System
Device: Oxford® 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.
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.
The study is designed as a prospective, multi-center, non-randomized post approval study. There are two phases to this study:
- A complications study where patients will be followed for at least 2 years to record all complications that may occur, and
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578994
|United States, Illinois|
|Barrington Orthopedic Specialissts|
|Schaumburg, Illinois, United States, 60195|
|United States, Ohio|
|Joint Implant Surgeons|
|New Albany, Ohio, United States, 43054|
|United States, Tennessee|
|Mid-South Orthopedic Associates|
|Cordova, Tennessee, United States, 38018|
|United States, Texas|
|Texas Orthopedic Specialist|
|Bedford, Texas, United States, 76021|
|Texas Center for Joint Replacement|
|Plano, Texas, United States, 75093|
|United States, Virginia|
|Advanced Orthopaedic Centers|
|Richmond, Virginia, United States, 23294|
|Study Director:||Kacy Arnoldemail@example.com|