Calypso Knee System Clinical Sub-study, OUS Continued Evaluation

Moximed

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Osteoarthritis, Knee

Interventions

Calypso Knee SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Change at 24 months relative to baseline

Data from ClinicalTrials.gov

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