Status:
COMPLETED
Calypso Knee System Clinical Study, OUS
Lead Sponsor:
Moximed
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief 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.
Detailed Description
Prospective, multicenter clinical study of the Calypso Knee System. A total of 81 subjects were enrolled in this study. Male or female subjects age 25 to 65 years, with a diagnosis of medial knee oste...
Eligibility Criteria
Inclusion
- Participants age - 25 to 65 years
- Body Mass Index (BMI) of \< 35, Weight \< 300 lbs (136 kg)
- Knee osteoarthritis pain on the inner side of knee that has continued after at least 6 months of non-operative treatment
Exclusion
- Symptoms of osteoarthritis in the other knee or in lateral (outer) or patellofemoral compartments of the target knee
- Knee ligament or meniscal instability
- 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
Key Trial Info
Start Date :
February 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2025
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT03838978
Start Date
February 8 2019
End Date
March 14 2025
Last Update
April 10 2025
Active Locations (5)
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1
UZ Gent
Ghent, Belgium
2
SPORTO
Lodz, Poland
3
Zagiel Med Hospital
Lublin, Poland
4
Carolina Medical Center
Warsaw, Poland