RecruitingNot ApplicableNCT06368700

The HYALEX Pivotal Study

The HYALEX Freestyle™ Resurfacing System Pivotal Study: A Multicenter, Single-Arm, Pivotal Study of the HYALEX Freestyle Resurfacing Implant


Sponsor

Hyalex Orthopaedics, Inc.

Enrollment

85 participants

Start Date

Apr 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A multicenter, open-label, single-arm, pivotal study to evaluate the safety and effectiveness of the HYALEX Freestyle Resurfacing System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment, will be enrolled in the study and undergo implantation of the HYALEX Freestyle Resurfacing Implant.


Eligibility

Min Age: 22 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Hyalex Knee Cartilage System for people with damaged chondral or osteochondral area. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 22 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHyalex Knee Cartilage System

Surgical implantation of the Hyalex Knee Cartilage System


Locations(4)

Horizon Clinical Research

La Mesa, California, United States

Ochsner Sports Medicine Institute

New Orleans, Louisiana, United States

Hospital for Special Surgery

New York, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

View Full Details on ClinicalTrials.gov

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NCT06368700