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Calypso Knee System Clinical Study

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 : July 8, 2021
Sponsor:
Information provided by (Responsible Party):
Moximed

Tracking Information
First Submitted Date  ICMJE September 4, 2018
First Posted Date  ICMJE September 14, 2018
Last Update Posted Date July 8, 2021
Actual Study Start Date  ICMJE September 19, 2018
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Calypso Knee System Clinical Study
Official Title  ICMJE Evaluation of the Calypso Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single Arm Study Design
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Calypso
Calypso Knee System
Intervention: Device: Calypso Knee System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 29, 2020)
81
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2018)
80
Estimated Study Completion Date  ICMJE September 2025
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03671213
Other Study ID Numbers  ICMJE CP0001 (formerly CLIN102837)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Moximed
Study Sponsor  ICMJE Moximed
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rose Weinstein Moximed
PRS Account Moximed
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP