Back to resultsCalypso Knee System Clinical Sub-study, OUS Continued Evaluation
Primary Purpose
Osteoarthritis, Knee
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Calypso Knee System
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
- 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
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Calypso Knee System
Arm Description
Calypso Knee System
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04548882
Brief Title
Calypso Knee System Clinical Sub-study, OUS Continued Evaluation
Official Title
Continued 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
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study closed based on continued restrictions around COVID-19
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
October 12, 2021 (Actual)
Study Completion Date
October 12, 2021 (Actual)
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
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
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
0 (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
Other Intervention Name(s)
Calypso 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
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
Description
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
Time Frame
Change at 24 months relative to baseline
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
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
12. IPD Sharing Statement
Learn more about this trial
Calypso Knee System Clinical Sub-study, OUS Continued Evaluation
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