Calypso Knee System Clinical Sub-study, OUS Continued Evaluation

Moximed

Status: Withdrawn

Conditions: Osteoarthritis, Knee

Treatments: Device: Calypso Knee System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04548882

CP0004

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Calypso Knee System

Experimental group

Description:

Calypso Knee System

Treatment:

Device: Calypso Knee System