Calypso Knee System Clinical Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03671213 |
Recruitment Status :
Active, not recruiting
First Posted : September 14, 2018
Last Update Posted : March 3, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis, Knee | Device: Calypso Knee System | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 81 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Single Arm Study Design |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of the Calypso Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis |
Actual Study Start Date : | September 19, 2018 |
Actual Primary Completion Date : | January 17, 2022 |
Estimated Study Completion Date : | September 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: Calypso
Calypso Knee System
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Device: 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 Name: Calypso System |
- Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Score from baseline [ Time Frame: Change at 24 months relative to baseline ]The WOMAC Pain score is derived from a sub-section of the Knee injury and Osteoarthritis Outcome Score (KOOS) Knee Survey. The WOMAC Pain scores range from 0-100 with lower scores considered lower pain.
- Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function Score from baseline [ Time Frame: Change at 24 months relative to baseline ]The WOMAC Function score is derived from a sub-section of the Knee injury and Osteoarthritis Outcome Score (KOOS) Knee Survey. The WOMAC Function scores range from 0-100 with lower scores considered to have better function.
- Incidence of Treatment-Emergent Adverse Events resulting in Secondary Surgical Interventions [ Time Frame: From baseline to 24 months ]Incidence of Secondary Surgical Intervention due to implant related Adverse Events
- Maintenance of Implant Integrity by Radiographic Review [ Time Frame: From baseline to 24 months ]Implant integrity will be assessed by radiographic review to verify that the implant is not disassembled

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 25 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671213
United States, Missouri | |
Missouri Orthopaedic Institute | |
Columbia, Missouri, United States, 65212 | |
United States, New York | |
Hospital for Special Surgery | |
New York, New York, United States, 10021 | |
United States, Ohio | |
Jameson Crane Sports Medicine Institute | |
Columbus, Ohio, United States, 43202 | |
United States, Oregon | |
Oregon Health and Science University | |
Portland, Oregon, United States, 97239 | |
United States, Virginia | |
University of Virginia | |
Charlottesville, Virginia, United States, 22903 |
Study Director: | Rose Weinstein | Moximed |
Responsible Party: | Moximed |
ClinicalTrials.gov Identifier: | NCT03671213 |
Other Study ID Numbers: |
CP0001 (formerly CLIN102837) |
First Posted: | September 14, 2018 Key Record Dates |
Last Update Posted: | March 3, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |