The HYALEX Pivotal Study

Recruiting now · Not applicable

Conditions studied: Damaged Chondral or Osteochondral Area

In brief

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.

Key facts

Study ID

NCT06368700

Run by

Hyalex Orthopaedics, Inc.

People needed

85

Starts

2024-04-04

Expected to finish

2028-12-01

Last updated by the study team

2026-04-16

Who can join

Age: 22 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• HYALEX Implant, Surgical Technique, and Lesion Site Exclusions:
• Known allergy to polyurethanes, bone cement, acrylic, or titanium.
• Lack of 2mm of cartilage (ICRS Grade 0 to 2) and 2mm of vital bone wall on all sides of the implant site.
• Osteochondral defect affecting subchondral bone more than 11mm in depth from adjacent non-defect articular surface.
• Bipolar cartilage lesions involving patellar or tibial lesions ICRS Grade 3 - 4 opposite the lesion intended for treatment.
• Insufficient bone stock or bone density determined intra-operatively preventing implant press fit.
• Patient Orthopaedic Health Exclusions:
• Kellgren and Lawrence (KL) grade 3 or 4 on standing radiographs.
• Hip-knee-ankle (HKA) angle of greater than +/- 8 degrees (varus or valgus malalignment > 8 degrees) on standing X-ray.
• Lack of normally functioning contralateral knee that restricts activity.
• Recent Osteochondritis Dissecans within 1 year.
• Diagnosis of a concomitant knee injury which the investigator believes may interfere with study participation or confound effectiveness assessment.
• 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:
• Previous surgical cartilage treatment in the index knee within the last 6 months
• 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:
• Any known history of inflammatory arthropathy or untreated or uncontrolled crystal-deposition arthropathy.
• Current cigarette smoker or user of other nicotine products.
• Known Type 1 or Type 2 insulin-dependent diabetes mellitus.
• Currently undergoing immunosuppressive therapy or long-term steroid use (corticosteroid, excluding inhalers) or within 3 months prior to surgery.

Where it is running

• Horizon Clinical Research — La Mesa, California, United States (enrolling)
• Ochsner Sports Medicine Institute — New Orleans, Louisiana, United States (enrolling)
• Hospital for Special Surgery — New York, New York, United States (enrolling)
• Oregon Health & Science University — Portland, Oregon, United States (enrolling)

Full record on ClinicalTrials.gov

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