Episealer Knee System vs Microfracture Surgery for Osteoarthritis

Recruiting in Palo Alto (17 mi)

+17 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Episurf Medical Inc.

Trial Summary

What is the purpose of this trial?

This trial is testing a knee implant called the Episealer Knee System on patients with specific knee damage causing pain or disability. The implants aim to repair the damaged areas, improving knee function and reducing pain.

Eligibility Criteria

This trial is for adults aged 30-70 with knee pain from osteoarthritis, who have one or two specific types of knee damage that can be treated surgically. Participants should not be pregnant, planning pregnancy within 24 months, or have a BMI over 37. They must not have certain other knee conditions, previous treatments within six months (except debridement), drug/alcohol abuse history in the last six months, and must be able to follow study procedures.

Inclusion Criteria

I have up to two cartilage defects between 1.5 and 4.0 cm2 each.

My knee pain is severe, and my overall knee function is poor.

I have a knee injury with a specific size of damaged cartilage.

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Exclusion Criteria

Have any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the device's safety and performance.

I have an immune system condition or have been on medication that affects my immune system.

I have another knee injury that could affect the study's assessment of my main knee issue.

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Treatment Details

Interventions

Episealer Knee System (Orthopedic Implant)
Microfracture (Cartilage Repair)

Trial OverviewThe Episealer Knee System clinical trial tests a surgical treatment for people with painful knee lesions due to osteoarthritis. It compares the effectiveness of the Episealer device against microfracture surgery in improving symptoms. The study randomly assigns participants to either receive the Episealer implant or undergo microfracture surgery.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Episealer Knee SystemExperimental Treatment1 Intervention

The experimental arm will comprise of subjects that will be treated with the Episealer Knee System.

Group II: MicrofracturePlacebo Group1 Intervention

The control arm will comprise of subjects that will receive a Microfracture surgery.