Calypso Knee System Clinical Sub-study, OUS Continued Evaluation

NCT04548882 | Withdrawn FDA Device

• 1 other identifier: CP0004
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Calypso Knee System Clinical Study, OUS for subjects with symptomatic osteoarthritis of the medial compartment of the knee. The sub-study will achieve continued evaluation of the safety and clinical effectiveness of the Calypso Knee System.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of this pilot study is the rate of individual subject success at 24 months. A subject will be declared a clinical success if all of the following conditions are met

  1. Clinically Significant improvement in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain 2. Clinically Significant improvement in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function 3. Freedom from applicable device-related SAEs requiring surgical intervention 4. Maintenance of Implant Integrity by Radiographic Review

  Change at 24 months relative to baseline

Study Arms (1)

Calypso Knee System

EXPERIMENTAL

Calypso Knee System

Device: Calypso Knee System

Interventions

Calypso Knee System 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: Calypso 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
• 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

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexandra Kraenzlin

  Moximed

  STUDY DIRECTOR

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: September 8, 2020
• First Posted: September 16, 2020
• Study Start: September 11, 2020
• Primary Completion: October 12, 2021
• Study Completion: October 12, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-11