A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System
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|ClinicalTrials.gov Identifier: NCT00578994|
Recruitment Status : Active, not recruiting
First Posted : December 21, 2007
Last Update Posted : June 16, 2017
|Condition or disease||Intervention/treatment|
|Osteoarthritis Avascular Necrosis||Device: Oxford® Meniscal Unicompartmental Knee System|
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.
|Study Type :||Observational|
|Actual Enrollment :||388 participants|
|Official Title:||A Prospective, Non-randomized, Multicenter Study of the Oxford® Meniscal Unicompartmental Knee System|
|Study Start Date :||March 2006|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2019|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Arnoldfirstname.lastname@example.org|