Evaluating a new knee cartilage replacement system for patients with cartilage damage

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

This study is testing a new knee cartilage replacement system to see if it can help people with painful cartilage damage in their knees feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 85 (estimated)
• Ages: 22 Years to 70 Years
• Sex: All
• Sponsor: Hyalex Orthopaedics, Inc. (Industry-sponsored)
• Locations: 4 sites (La Mesa, California and 3 other locations)
• Trial ID: NCT06368700 on ClinicalTrials.gov

What this trial studies

The Hyalex Early Feasibility Study is a multicenter, open-label, single-arm study designed to assess the safety and technical performance of the HYALEX Knee Cartilage System. This intervention targets patients with symptomatic cartilage injuries in the knee, specifically those with ICRS Grade 3 or 4 lesions. Participants will undergo implantation of the HYALEX Knee Implant, with the study structured in two phases to evaluate different patient criteria and lesion complexities. The study aims to gather data on the effectiveness of this new treatment approach for knee cartilage repair.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21-70 with specific knee cartilage injuries that have not responded to non-operative treatments.

Not a fit: Patients with multiple untreated lesions or those outside the specified age and BMI range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new surgical option for patients suffering from significant knee cartilage damage, potentially improving their quality of life and mobility.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in cartilage repair, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

La Mesa, California and 3 other locations

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

Study contacts

• Study coordinator: Chris Cain

Conditions Damaged Chondral or Osteochondral Area