Calypso Knee System Clinical Sub-study, OUS Continued Evaluation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Calypso Knee System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants age - 25 to 65 years Body Mass Index (BMI) of < 35, Weight < 300 lbs Knee osteoarthritis pain on the inner side of knee that has continued after at least 6 months of non-operative treatment Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calypso Knee System<br>Calypso Knee System | Device: Calypso Knee System<br>* 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.<br>* Other names: Calypso System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Clinically Significant improvement in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Clinically Significant improvement in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function Freedom from applicable device-related SAEs requiring surgical intervention Maintenance of Implant Integrity by Radiographic Review | Change at 24 months relative to baseline |