The Hyalex Early Feasibility Study (EFS)

Description

The Hyalex Early Feasibility Study is a prospective, multicenter, open-label, single-arm, 2-phase early feasibility 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, will be enrolled in the study and undergo implantation of the HYALEX Knee Implant.

Conditions

Cartilage Injury, Cartilage Damage

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Study Overview

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Study Details

Study overview

The Hyalex Early Feasibility Study is a prospective, multicenter, open-label, single-arm, 2-phase early feasibility 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, will be enrolled in the study and undergo implantation of the HYALEX Knee Implant.

The Hyalex EFS: A Prospective, Multicenter, Single-Arm, 2-Phase Early Feasibility Study (EFS) of the HYALEX® Knee Cartilage System

The Hyalex Early Feasibility Study (EFS)

Condition
Cartilage Injury
Intervention / Treatment

-

Contacts and Locations

La Mesa

Horizon Clinical Research, La Mesa, California, United States, 91942

New Orleans

Ochsner Sports Medicine Institute, New Orleans, Louisiana, United States, 70121

New York

Hospital for Special Surgery, New York, New York, United States, 10021

Portland

Oregon Health & Science University, Portland, Oregon, United States, 97239

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 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. Untreated ACL and/or PCL deficiency or complex ligamentous instability of the study knee according to IKDC Grade C (abnormal) or D (severely abnormal).
  • 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.
  • 1. Any known history of inflammatory arthropathy or 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 (anabolic or corticosteroid, excluding inhalers) or within 3 months prior to surgery.

Ages Eligible for Study

21 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hyalex Orthopaedics, Inc.,

Study Record Dates

2026-10