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Completed
NCT03838978
Calypso Knee System Clinical Study, OUS
Conditions: Osteoarthritis, Knee
Sex: All
Ages: 25 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 81
Sponsor: Moximed
Location: UZ Gent Ghent
Summary
A study to evaluate the safety and effectiveness of the Calypso Knee System when used in subjects with symptomatic osteoarthritis of the medial compartment of the knee.
Eligibility Criteria
Inclusion Criteria:
1. Participants age - 25 to 65 years
2. Body Mass Index (BMI) of \< 35, Weight \< 300 lbs (136 kg)
3. Knee osteoarthritis pain on the inner side of knee that has continued after at least 6 months of non-operative treatment
Exclusion Criteria:
1. Symptoms of osteoarthritis in the other knee or in lateral (outer) or patellofemoral compartments of the target knee
2. Knee ligament or meniscal instability
3. Other bone or joint conditions such as Rheumatoid arthritis, Paget's disease, Charcot's disease or general conditions such as allergy or hypersensitivity to certain metals, active infection, certain neurological conditions, use of medication such as steroids or chemotherapy that could impact study participation or results
Source: ClinicalTrials.gov (NCT03838978). StuddyBuddy aggregates publicly available trial information.