Calypso Knee System Clinical Sub-study, OUS Continued Evaluation

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04548882
• Other study ID #: CP0004
• Status: Withdrawn
• Phase: N/A
• Start date: September 11, 2020
• Est. completion date: October 12, 2021

Study information

• Verified date: November 2021
• Source: Moximed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This sub-study will be a single-arm, prospective, multi-center sub-study for continued evaluation of the safety and clinical effectiveness of Calypso Knee System using an additional measure of post-operative activity improvement.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 12, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Moximed

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinically Significant improvement in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain; Clinically Significant improvement in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function; Freedom from applicable device-related SAEs requiring surgical intervention; Maintenance of Implant Integrity by Radiographic Review	Change at 24 months relative to baseline