A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/9/2018 |
Start Date: | March 2006 |
End Date: | June 2019 |
A Prospective, Non-randomized, Multicenter Study of the Oxford® Meniscal Unicompartmental Knee System
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.
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:
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.
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.
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
We found this trial at
6
sites
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