Back to resultsCalypso Knee System Clinical Study, OUS
Primary Purpose
Osteoarthritis, Knee
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Calypso Knee System (Implantable Shock Absorber)
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
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
Sites / Locations
- UZ Gent
- Zagiel Med Hospital
- Carolina Medical Center
- Mirai Clinic
- SPORTO
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Calypso Knee System
Arm Description
Calypso Knee System
Outcomes
Primary Outcome Measures
Percentage of Participants With 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)
Secondary Outcome Measures
Time to Full Weight Bearing (Days)
WOMAC Pain Percent Change to Month 3
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03838978
Brief Title
Calypso Knee System Clinical Study, OUS
Official Title
Evaluation of the Calypso Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis, OUS
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 8, 2019 (Actual)
Primary Completion Date
January 17, 2022 (Actual)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moximed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Arm Study Design
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calypso Knee System
Arm Type
Experimental
Arm Description
Calypso Knee System
Intervention Type
Device
Intervention Name(s)
Calypso Knee System (Implantable Shock Absorber)
Other Intervention Name(s)
MISHA(TM) Knee System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Composite Clinical Success (CCS)
Description
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)
Time Frame
From baseline to 24 months
Secondary Outcome Measure Information:
Title
Time to Full Weight Bearing (Days)
Time Frame
Through study completion (number of days to full weight bearing)
Title
WOMAC Pain Percent Change to Month 3
Description
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.
Time Frame
From baseline to 3 months
Title
WOMAC Pain Percent Change to Month 24
Description
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.
Time Frame
From baseline to 24 months
Title
WOMAC Function Percent Change to Month 3
Description
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.
Time Frame
From baseline to 3 months
Title
WOMAC Function Percent Change to Month 24
Description
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.
Time Frame
From baseline to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Kraenzlin
Organizational Affiliation
Moximed
Official's Role
Study Director
Facility Information:
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
Zagiel Med Hospital
City
Lublin
Country
Poland
Facility Name
Carolina Medical Center
City
Warszawa
Country
Poland
Facility Name
Mirai Clinic
City
Warszawa
Country
Poland
Facility Name
SPORTO
City
Łódź
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
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Calypso Knee System Clinical Study, OUS
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