A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System
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About
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.
Full 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:
- 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.
Enrollment
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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
Trial design
388 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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