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Calypso Knee System Clinical Study

Sponsor
Moximed (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03671213
Collaborator
(none)
81
Enrollment
5
Locations
1
Arm
83.4
Anticipated Duration (Months)
16.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Calypso Knee System
 N/A

Detailed Description

Prospective, multicenter clinical study of the Calypso Knee System. 80 subjects will be enrolled in this study at up to 10 investigational sites located in the U.S. 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).

Study Design

Study Type:
Interventional
Actual Enrollment :
81 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single Arm Study DesignSingle 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 :
Sep 19, 2018
Actual Primary Completion Date :
Jan 17, 2022
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Calypso

Calypso Knee System

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 Names:
  • Calypso System

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Score from baseline [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.

    2. Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function Score from baseline [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.

    3. Incidence of Treatment-Emergent Adverse Events resulting in Secondary Surgical Interventions [From baseline to 24 months]

      Incidence of Secondary Surgical Intervention due to implant related Adverse Events

    4. Maintenance of Implant Integrity by Radiographic Review [From baseline to 24 months]

      Implant integrity will be assessed by radiographic review to verify that the implant is not disassembled

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Missouri Orthopaedic Institute Columbia Missouri United States 65212
    2 Hospital for Special Surgery New York New York United States 10021
    3 Jameson Crane Sports Medicine Institute Columbus Ohio United States 43202
    4 Oregon Health and Science University Portland Oregon United States 97239
    5 University of Virginia Charlottesville Virginia United States 22903

    Sponsors and Collaborators

    • Moximed

    Investigators

    • Study Director: Rose Weinstein, Moximed

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Moximed
    ClinicalTrials.gov Identifier:
    NCT03671213
    Other Study ID Numbers:
    • CP0001 (formerly CLIN102837)
    First Posted:
    Sep 14, 2018
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee

    Study Results

    No Results Posted as of Mar 3, 2022