Calypso Knee System Clinical Study

Study Overview
=================
Brief Summary
-----------------
A clinical 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. 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).

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

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Device: Calypso Knee System (Implantable Shock Absorber)


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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<br>Calypso Knee System | Device: Calypso Knee System (Implantable Shock Absorber)<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: MISHA(TM) Knee System;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Clinical Success (CCS) | A subject is considered a Composite Clinical Success (CCS), at 24 months, if the subject meets all of the following: Clinically significant improvement of at least 20% from baseline on the WOMAC pain questions in the KOOS Knee questionnaire with a change of ≥10 points Clinically significant improvement of at least 20% from baseline on the WOMAC function questions in the KOOS Knee questionnaire with a change of ≥10 points Freedom from the following device-related serious adverse events: Deep infection requiring surgical intervention (Both arms) Damage to adjacent neurovascular or ligament structures necessitating reconstruction (Both arms) Non-union (HTO only) Maintenance of implant integrity as evaluated by radiographic assessment Endpoint Subsequent Surgical Intervention (SSI) | From baseline to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Full Weight Bearing (Days) | Any subject that had evaluable data was deemed eligible for effectiveness evaluation and included in the analysis. | Through study completion (Number of days to full weight bearing) | 
| WOMAC Pain Percent Change to Month 3 | Any subject that had evaluable data, yet had not undergone a conversion to arthroplasty was deemed eligible for effectiveness evaluation and included in the analysis. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems. | From baseline to 3 months | 
| WOMAC Pain Percent Change to Month 24 | Any subject that had evaluable data, yet had not undergone a conversion to arthroplasty was deemed eligible for effectiveness evaluation and included in the analysis. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems. | From baseline to 24 months | 
| WOMAC Function Percent Change to Month 3 | Any subject that had evaluable data, yet had not undergone a conversion to arthroplasty was deemed eligible for effectiveness evaluation and included in the analysis. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems. | From baseline to 3 months | 
| WOMAC Function Percent Change to Month 24 | Any subject that had evaluable data, yet had not undergone a conversion to arthroplasty was deemed eligible for effectiveness evaluation and included in the analysis. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its complete and original format (with permission), and WOMAC scores can be calculated from the KOOS Knee questionnaire. The response to each question is summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems. | From baseline to 24 months |