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Calypso Knee System Clinical Study

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ClinicalTrials.gov Identifier: NCT03671213
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Moximed

Study Description
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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
Osteoarthritis, Knee Device: Calypso Knee System Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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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 Name: Calypso System


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

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


Contacts
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Contact: Rose Weinstein 415-312-0255 rsweinstein@moximed.com
Contact: Vijaya Krishnamoorthy, PhD 510-887-3328 vkrishnamoorthy@moximed.com

Locations
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United States, Missouri
Missouri Orthopaedic Institute Active, not recruiting
Columbia, Missouri, United States, 65212
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Research Assistant    212-606-1775      
Principal Investigator: Andreas Gomoll, MD         
United States, Ohio
Jameson Crane Sports Medicine Institute Recruiting
Columbus, Ohio, United States, 43202
Contact: Angela Pedroza    614-293-2410    angela.pedroza@osumc.edu   
Principal Investigator: David Flanigan, MD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Kaytee Arnold    503-418-8673    arnoldka@ohsu.edu   
Principal Investigator: Dennis Crawford, MD         
Sponsors and Collaborators
Moximed
Investigators
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Study Director: Rose Weinstein Moximed
More Information
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Responsible Party: Moximed
ClinicalTrials.gov Identifier: NCT03671213     History of Changes
Other Study ID Numbers: CP0001 (formerly 102837)
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases