Calypso Knee System Clinical Study, OUS

Not Applicable

Completed

Conditions: Osteoarthritis, Knee

Interventions: Device: Calypso Knee System (Implantable Shock Absorber)

Registration Number: NCT03838978

Lead Sponsor: Moximed

Brief 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 81

Inclusion Criteria

Participants age - 25 to 65 years
Body Mass Index (BMI) of < 35, Weight < 300 lbs (136 kg)
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Calypso Knee System	Calypso Knee System (Implantable Shock Absorber)	Calypso Knee System

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Composite Clinical Success (CCS)	From baseline to 24 months	A subject is considered a Composite Clinical Success (CCS), at 24 months, if the subject meets all of the following: 1. 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 2. 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 3. 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) 4. Maintenance of implant integrity as evaluated by radiographic assessment 5. Endpoint Subsequent Surgical Intervention (SSI)

Secondary Outcome Measures

Name	Time	Method
Time to Full Weight Bearing (Days)	Through study completion (number of days to full weight bearing)
WOMAC Pain Percent Change to Month 3	From baseline to 3 months	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.
WOMAC Pain Percent Change to Month 24	From baseline to 24 months	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.
WOMAC Function Percent Change to Month 3	From baseline to 3 months	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.
WOMAC Function Percent Change to Month 24	From baseline to 24 months	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.

Trial Locations

Locations (5): Carolina Medical Center
🇵🇱
Warszawa, Poland
UZ Gent
🇧🇪
Gent, Belgium
Zagiel Med Hospital
🇵🇱
Lublin, Poland
Mirai Clinic
🇵🇱
Warszawa, Poland
SPORTO
🇵🇱
Łódź, Poland