The Hyalex First-in-Human Study

June 26, 2025 updated by: Hyalex Orthopaedics, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Warsaw, Poland, 00-855
        • Recruiting
        • LIFE Medical Center
        • Contact:
        • Principal Investigator:
          • Urszula Zdanowicz, M.D.
      • Łódź, Poland, 09-038

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria - Phase 1

  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.

Inclusion Criteria - Phase 2

  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. Symptomatic total treatable area 1 - 10cm2.
  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.

Exclusion Criteria - Phase 1 & 2

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.
  4. Insufficiency fracture of the femoral condyle or tibial plateau.
  5. Recent Osteochondritis Dissecans within 1 year.
  6. Diagnosis of a concomitant knee injury which the investigator believes may interfere with study participation or confound effectiveness assessment.
  7. Any known systemic cartilage and/or bone disorder, such as but not limited to osteoporosis, chondrodysplasia or osteogenesis imperfecta.
  8. A symptomatic musculoskeletal condition in the lower limbs that could impede effectiveness measurements in the target knee.
  9. Any known tumor of the treatment knee.
  10. Prior radiation therapy to the knee joint.
  11. Clinically significant or symptomatic vascular or neurological disorder of the lower extremities affecting gait or function.
  12. Untreated ACL and/or PCL deficiency or complex ligamentous instability of the study knee according to IKDC Grade C (abnormal) or D (severely abnormal).

Previous Surgery and Intervention Exclusions:

  1. Previous surgery in the past 6 months on the index knee except for:

    1. Diagnostic knee arthroscopy and/or debridement / chondroplasty, and
    2. Meniscectomy
  2. Previous intra-articular injections, including HA and steroids, within the last 3 months prior to the date of surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyalex Cartilage System
Implantation of Hyalex Cartilage Knee Implant
Device: Surgical (Hyalex Cartilage Knee Implant)
Implantation of Hyalex Cartilage Knee Implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from implant rejection and infection.
Time Frame: Through 24 months.
Assess the safety (implant rejection, infection) and tolerability of the Hyalex Cartilage Implant.
Through 24 months.
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) from baseline at 12 months.
Time Frame: Through 12 months.
The KOOS assesses patient pain, other symptoms, function in daily living, function in sport and recreation, and knee related quality of life. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Through 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hyalex Orthopaedics, Inc.

Investigators

  • Principal Investigator: Marcin Domzalski, MD, SPORTO, Łódź, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 29, 2025

Last Update Submitted That Met QC Criteria

June 26, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CL-00003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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