Calypso Knee System Clinical Study

April 12, 2024 updated by: Moximed

Evaluation of the Calypso Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis

A clinical 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective, multicenter clinical study of the Calypso Knee System. 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

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Missouri Orthopaedic Institute
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery
    • Ohio
      • Columbus, Ohio, United States, 43202
        • Jameson Crane Sports Medicine Institute
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants age - 25 to 65 years
  2. Body Mass Index (BMI) of < 35, Weight < 300 lbs
  3. Knee osteoarthritis pain on the inner side of knee that has continued after at least 6 months of non-operative treatment

Exclusion Criteria:

  1. Symptoms of osteoarthritis in the other knee or in lateral (outer) or patellofemoral compartments of the target knee
  2. Knee ligament or meniscal instability
  3. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Calypso Knee System
Device: Calypso Knee System (Implantable Shock Absorber)
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:
  • MISHA® Knee System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  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)
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)
Any subject that had evaluable data was deemed eligible for effectiveness evaluation and included in the analysis.
Through study completion (Number of days to full weight bearing)
WOMAC Pain Percent Change to Month 3
Time Frame: From baseline to 3 months

Any subject that had evaluable data, yet had not undergone a conversion to arthroplasty was deemed eligible for effectiveness evaluation and included in the analysis.

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

Any subject that had evaluable data, yet had not undergone a conversion to arthroplasty was deemed eligible for effectiveness evaluation and included in the analysis.

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

Any subject that had evaluable data, yet had not undergone a conversion to arthroplasty was deemed eligible for effectiveness evaluation and included in the analysis.

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

Any subject that had evaluable data, yet had not undergone a conversion to arthroplasty was deemed eligible for effectiveness evaluation and included in the analysis.

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

This is where you will find people and organizations involved with this study.

Sponsor

Moximed

Investigators

  • Principal Investigator: David Flanigan, MD, The Ohio State University Wexner Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2018

Primary Completion (Actual)

January 17, 2022

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

September 4, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (Actual)

September 14, 2018

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP0001 (formerly CLIN102837)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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