The HYALEX Pivotal Study

NCT06368700 | Recruiting DMC FDA Device

• 1 other identifier: CL-00001
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Damaged Chondral or Osteochondral Area

Outcome Measures

Primary Outcomes (2)

• Composite Primary Endpoint

  * 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

• Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) at 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

Study Arms (1)

HYALEX Freestyle Resurfacing System

EXPERIMENTAL

Implantation of the HYALEX Implant

Device: Hyalex Knee Cartilage System

Interventions

Hyalex Knee Cartilage System DEVICE

Surgical implantation of the Hyalex Knee Cartilage System

HYALEX Freestyle Resurfacing System

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years.
• Body Mass Index (BMI) ≤ 40.
• Up to two treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial and/or lateral femoral condyle.
• 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.
• Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
• Ligamentously stable knee.
• 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.

You may not qualify if:

• 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.
• 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 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.
• Any known history of inflammatory arthropathy or untreated or uncontrolled crystal-deposition arthropathy.
• Current cigarette smoker or user of other nicotine products.

Sponsors & Collaborators

• Hyalex Orthopaedics, Inc.: lead

Study Sites (4)

Horizon Clinical Research

La Mesa, California, 91942, United States

RECRUITING

Ochsner Sports Medicine Institute

New Orleans, Louisiana, 70121, United States

RECRUITING

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Central Study Contacts

Chris Cain

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: April 4, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (4)