Calypso Knee System Clinical Study, OUS

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 osteoarthritis and study knee pain with an overall WOMAC pain score ≥ 40 (scale 0-100). The Calypso group was investigated under two clinical protocols, CP0001 in the USA, and CP0002 in Europe. Both clinical protocols followed the same supporting protocols and plans, such as radiographic, statistical, Clinical Events Committee (CEC), etc. The results from the combined analysis have been reported in both NCT03671213 (CP0001) and NCT03838978 (CP0002). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03838978
Study type	Interventional
Source	Moximed
Contact
Status	Active, not recruiting
Phase	N/A
Start date	February 8, 2019
Completion date	June 2025

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