The HYALEX Pivotal Study

April 13, 2026 updated by: Hyalex Orthopaedics, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

85

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

  • United States
    • California
      • La Mesa, California, United States, 91942
        • Recruiting
        • Horizon Clinical Research
        • Contact:
        • Principal Investigator:
          • Scott Hacker, M.D.
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Sports Medicine Institute
        • Contact:
        • Principal Investigator:
          • Brian Godshaw, M.D.
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Contact:
        • Principal Investigator:
          • Sabrina Strickland, M.D.
        • Sub-Investigator:
          • Andreas Gomoll, M.D.
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Principal Investigator:
          • Dennis Crawford, M.D.

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. 22-70 years.
  2. Body Mass Index (BMI) ≤ 40.
  3. Up to two treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial and/or lateral femoral condyle.
  4. Up to 2 implants (one implant per condyle) to treat up to 2 individual symptomatic lesions with a total summative area up to 4.52cm2 / condyle.
  5. Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
  6. Ligamentously stable knee.
  7. Failure of non-operative treatment (e.g., physical therapy, physician-directed at home exercise program, intra-articular injections, bracing) for at least 4 months prior to consideration for participation in the study.

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 cartilage (ICRS Grade 0 to 2) 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.
  2. Hip-knee-ankle (HKA) angle of greater than +/- 8 degrees (varus or valgus malalignment > 8 degrees) on standing X-ray.
  3. Lack of normally functioning contralateral knee that restricts activity.
  4. Recent Osteochondritis Dissecans within 1 year.
  5. Diagnosis of a concomitant knee injury which the investigator believes may interfere with study participation or confound effectiveness assessment.
  6. 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 surgical cartilage treatment in the index knee within the last 6 months
  2. Previous intra-articular injections, including HA and steroids, within the last 3 months prior to the date of surgery.

Patient Overall Health and Health History Exclusions:

  1. Any known history of inflammatory arthropathy or untreated or uncontrolled crystal-deposition arthropathy.
  2. Current cigarette smoker or user of other nicotine products.
  3. Known Type 1 or Type 2 insulin-dependent diabetes mellitus.
  4. Currently undergoing immunosuppressive therapy or long-term steroid use (corticosteroid, excluding inhalers) or within 3 months prior to 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 Freestyle Resurfacing System
Implantation of the HYALEX Implant
Device: Hyalex Knee Cartilage System
Surgical implantation of the Hyalex Knee Cartilage System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) at 12 months.
Time Frame: 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.
12 months
Composite Primary Endpoint
Time Frame: 12 months
  • A clinically significant improvement in KOOS Pain score;
  • A clinically significant improvement in KOOS ADL score;
  • Lack of treatment-related SAEs; and
  • Absence of secondary surgical intervention defined as HYALEX Freestyle Resurfacing Implant removal or revision due to a treatment-related finding.
12 months

Collaborators and Investigators

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

Sponsor

Hyalex Orthopaedics, Inc.

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)

April 4, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CL-00001

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.

No

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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