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Completed

NCT Number: NCT03838978

Calypso Knee System Clinical Study, OUS

A 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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Gent, Ghent, Belgium

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About this study

Prospective, multicenter clinical study of the Calypso Knee System. A total of 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants age - 25 to 65 years
  • Body Mass Index (BMI) of < 35, Weight < 300 lbs (136 kg)
  • 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

Treatment and study plan

Calypso Knee System (Implantable Shock Absorber)

Device

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(R) Knee System

Primary outcomes

  1. Percentage of Participants With 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:

    • 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
    • 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
    • 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)
    • Maintenance of implant integrity as evaluated by radiographic assessment
    • Endpoint Subsequent Surgical Intervention (SSI)

Secondary outcomes

  1. Time to Full Weight Bearing (Days)

    Time frame: Through study completion (number of days to full weight bearing)

  2. WOMAC Pain Percent Change to Month 3

    Time frame: From baseline to 3 months

    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.

  3. WOMAC Pain Percent Change to Month 24

    Time frame: From baseline to 24 months

    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.

  4. WOMAC Function Percent Change to Month 3

    Time frame: From baseline to 3 months

    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.

  5. WOMAC Function Percent Change to Month 24

    Time frame: From baseline to 24 months

    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.

Sponsors and collaborators

Lead sponsor

Moximed

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2025
First posted
Feb 12, 2019
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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