Calypso Knee System Clinical Study, OUS

NCT03838978 | Completed Results FDA Device

• 1 other identifier: CP0002 (formerly CLIN102918)
• Study Type: interventional
• Target: 81
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Composite Clinical Success (CCS)

  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 Outcomes (5)

• Time to Full Weight Bearing (Days)

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

• WOMAC Pain Percent Change to Month 3

  From baseline to 3 months

• WOMAC Pain Percent Change to Month 24

  From baseline to 24 months

• WOMAC Function Percent Change to Month 3

  From baseline to 3 months

• WOMAC Function Percent Change to Month 24

  From baseline to 24 months

Study Arms (1)

Calypso Knee System

EXPERIMENTAL

Calypso Knee System

Device: Calypso Knee System (Implantable Shock Absorber)

Interventions

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.

Also known as: MISHA(R) Knee System

Calypso Knee System

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Moximed: lead

Study Sites (5)

UZ Gent

Ghent, Belgium

Location

SPORTO

Lodz, Poland

Location

Zagiel Med Hospital

Lublin, Poland

Location

Carolina Medical Center

Warsaw, Poland

Location

Mirai Clinic

Warsaw, Poland

Location

Related Publications (1)

• Diduch DR, Crawford DC, Ranawat AS, Victor J, Flanigan DC. Implantable Shock Absorber Provides Superior Pain Relief and Functional Improvement Compared With High Tibial Osteotomy in Patients with Mild-to-Moderate Medial Knee Osteoarthritis: A 2-Year Report. Cartilage. 2023 Jun;14(2):152-163. doi: 10.1177/19476035231157335. Epub 2023 Feb 23.

  PMID: 36823955 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Alexandra Kraenzlin, Director of Clinical Affairs
• Organization: Moximed, Inc.

akraenzlin@moximed.com

+41 44 515 62 06

Study Officials

• David Flanigan, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Arm Study Design

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 12, 2019
• Study Start: February 8, 2019
• Primary Completion: January 17, 2022
• Study Completion: March 14, 2025
• Last Updated: April 10, 2025
• Results First Posted: June 29, 2023

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); PL (4)