NCT03838978

Calypso Knee System Clinical Study, OUS

Evaluation of the Calypso Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis, OUS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Moximed · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	Calypso Knee System (Implantable Shock Absorber)	The Calypso Knee System is an extra-capsular knee implant designed to fill the therapeutic gap between conservative care and more invasive surgical interventions for knee osteoarthritis.

Timeline

• Start date: 2019-02-08
• Primary completion: 2022-01-17
• Completion: 2025-03-14
• First posted: 2019-02-12
• Last updated: 2025-04-10
• Results posted: 2023-06-29

Locations

5 sites across 2 countries: Belgium, Poland

Regulatory

• FDA-regulated device study