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The objective of this study is to collect post market data on safety and performance of the Atlas Knee System in patients with osteoarthritis (OA) of the medial knee compartment through a 24 months post-operative follow-up period.
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The objective of this study is to collect post market data on safety and performance of the Atlas Knee System in patients with osteoarthritis (OA) of the medial knee compartment through a 24 months post-operative follow-up period. This study is designed as a post-market, prospective, multicenter, single arm study. The study population will consist of adult subjects older than 25 years of age, with a diagnosis of symptomatic and radiographic OA of the medial knee compartment.
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Inclusion criteria
Male or female, older than 25 years of age;
Have clinical symptoms in the study knee such as pain primarily localized to the medial aspect of the knee and generally exacerbated by weight bearing;
Radiographic confirmation of osteoarthritis of the medial knee compartment without bony erosion and best assessed using a Rosenberg view X-ray;
Have failed at least 6 months of conservative therapy prior to surgery with continued OA pain. Prior conservative therapy is defined as treatment including at least one of the following (OARSI Recommendations)9:
Have active knee flexion ≥ 90⁰;
Are able to give voluntary, written informed consent to participate in this clinical investigation.
Are, in the opinion of the Clinical Investigator, able to understand this clinical investigation, cooperate with the investigational procedures, and are willing to return for all required post-treatment follow up visits.
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0 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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