- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03838978
Calypso Knee System Clinical Study, OUS
Evaluation of the Calypso Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis, OUS
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Calypso Knee System
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Composite Clinical Success (CCS)
Time Frame: 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:
|
From baseline to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Full Weight Bearing (Days)
Time Frame: Through study completion (number of days to full weight bearing)
|
Through study completion (number of days to full weight bearing)
|
|
WOMAC Pain Percent Change to Month 3
Time Frame: 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.
|
From baseline to 3 months
|
WOMAC Pain Percent Change to Month 24
Time Frame: 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.
|
From baseline to 24 months
|
WOMAC Function Percent Change to Month 3
Time Frame: 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.
|
From baseline to 3 months
|
WOMAC Function Percent Change to Month 24
Time Frame: 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.
|
From baseline to 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Flanigan, MD, The Ohio State University Wexner Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP0002 (formerly CLIN102918)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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