Calypso Knee System Clinical Sub-study, OUS Continued Evaluation

Not Applicable

Withdrawn

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Calypso Knee System

• Registration Number: NCT04548882
• Lead Sponsor: Moximed

Brief Summary

Calypso Knee System Clinical Study, OUS for subjects with symptomatic osteoarthritis of the medial compartment of the knee. The sub-study will achieve continued evaluation of the safety and clinical effectiveness of the Calypso Knee System.

Detailed Description

This sub-study will be a single-arm, prospective, multi-center sub-study for continued evaluation of the safety and clinical effectiveness of Calypso Knee System using an additional measure of post-operative activity improvement.

Study Timeline

• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-08
• Study Start: 2020-09-11
• Study First Posted: 2020-09-16
• Primary Completion: 2021-10-12
• Study Completion: 2021-10-12
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Participants age - 25 to 65 years
2. Body Mass Index (BMI) of < 35, Weight < 300 lbs
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Calypso Knee System	Calypso Knee System	Calypso Knee System

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this pilot study is the rate of individual subject success at 24 months. A subject will be declared a clinical success if all of the following conditions are met	Change at 24 months relative to baseline	1. Clinically Significant improvement in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain; 2. Clinically Significant improvement in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function; 3. Freedom from applicable device-related SAEs requiring surgical intervention; 4. Maintenance of Implant Integrity by Radiographic Review