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RECRUITINGNA

The Hyalex First-in-Human Study

A Prospective, Multicenter, Single-Arm, 2-Phase First-in-Human Feasibility Study of the HYALEX® Cartilage System

NCT06344481•Hyalex Orthopaedics, Inc.

Summary

The Hyalex First-in-Human Study is a prospective, multicenter, open-label, single-arm, 2-phase, first-in-human study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment.

Eligibility

Age

21 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 21-65 years.
•2. Body Mass Index (BMI) ≤ 35.
•3. Singular treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial or lateral femoral condyle.
•4. Symptomatic, single treatable area 1 - 3.8cm2.
•5. Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
•6. Stable knee.
•7. Non-responsive to a minimum of 3 weeks of conservative treatment, consisting of non-steroidal anti-inflammatory drugs and/or physical therapy.
•1. 21-65 years.
•2. Body Mass Index (BMI) ≤ 35.
•3. Up to three treatable joint surface lesion(s), ICRS Grade 3 or 4, located on the medial or lateral femoral condyle(s).
+4 more criteria

Exclusion Criteria

•HYALEX Implant, Surgical Technique, and Lesion Site Exclusions:
•1. Known allergy to polyurethanes, bone cement, acrylic, or titanium.
•2. Lack of 2mm of healthy cartilage (ICRS Grade 0 or 1) and 2mm of vital bone wall on all sides of the implant site.
•3. Osteochondral defect affecting subchondral bone more than 11mm in depth from adjacent non-defect articular surface.
•4. Bipolar cartilage lesions involving patellar or tibial lesions ICRS Grade 3 - 4 opposite the lesion intended for treatment.
•5. Insufficient bone stock or bone density determined intra-operatively preventing implant press fit.
•Patient Orthopaedic Health Exclusions:
•1. Kellgren and Lawrence (KL) grade 3 or 4 on standing radiographs as defined:
•2. Hip-knee-ankle (HKA) angle of greater than +/- 5 degrees (varus or valgus malalignment \> 5 degrees) on standing X-ray.
•3. Lack of normally functioning contralateral knee that restricts activity.
+14 more criteria

Locations (2)

SPORTO

Lodz, Poland

LIFE Medical Center

Warsaw, Poland

Key Dates

Start Date

March 7, 2024

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

June 29, 2025

Enrollment

ESTIMATED participants

Conditions

Cartilage Injury

Interventions

Surgical (Hyalex Cartilage Knee Implant)

DEVICE

Contacts

Chris Cain

CONTACT

408-439-5154 chris.cain@hyalex.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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The Hyalex First-in-Human Study

Inclusion Criteria

Exclusion Criteria

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