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| ID | Type | Description | Link |
|---|---|---|---|
| P010014 | Other Identifier | FDA PMA |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxford® Meniscal Unicompartmental Knee | Patients with PKA using the Oxford® Meniscal Unicompartmental Knee System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxford® Meniscal Unicompartmental Knee System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship | Assessment of frequency of Revisions | Annually for 9 years post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Patients will be followed for at least 2 years to record all complications that may occur | 2 Years |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Kacy Arnold | kacy.arnold@zimmerbiomet.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrington Orthopedic Specialissts | Schaumburg | Illinois | 60195 | United States | ||
| Joint Implant Surgeons |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 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 |
| D001847 |
| Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |