Evaluating a new knee cartilage implant for treating cartilage injuries

A Prospective, Multicenter, Single-Arm, 2-Phase First-in-Human Feasibility Study of the HYALEX® Cartilage System

This study is testing a new knee cartilage implant to see if it can help people with painful cartilage injuries in their knees when other treatments haven't worked.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: Hyalex Orthopaedics, Inc. (industry)
• Drugs / interventions: radiation
• Locations: 2 sites (Lodz and 1 other locations)
• Trial ID: NCT06344481 on ClinicalTrials.gov

What this trial studies

The Hyalex First-in-Human Study is a prospective, multicenter, open-label, single-arm study aimed at assessing the safety and technical performance of the HYALEX Knee Cartilage System. This intervention targets patients with symptomatic cartilage injuries in the knee, specifically focusing on the replacement of damaged articular cartilage and bone in the femoral condyles. Eligible participants will undergo surgical treatment with the HYALEX implant, which is designed to address cartilage lesions that have not responded to conservative treatments. The study will be conducted in two phases, allowing for a thorough evaluation of the implant's effectiveness and safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21-65 with specific cartilage lesions in the knee that have not improved with conservative treatments.

Not a fit: Patients with multiple joint surface lesions or those who have not met the specified criteria for cartilage injury severity 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 knee cartilage injuries, potentially improving their quality of life and reducing pain.

How similar studies have performed: While this approach is novel, similar studies evaluating cartilage implants have shown promise in improving outcomes for patients with knee injuries.

Eligibility criteria

Inclusion Criteria - Phase 1

1. 21-65 years.
2. Body Mass Index (BMI) ≤ 35.
3. Singular treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial or lateral femoral condyle.
4. Symptomatic, single treatable area 1 - 3.8cm2.
5. Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
6. Stable knee.
7. Non-responsive to a minimum of 3 weeks of conservative treatment, consisting of non-steroidal anti-inflammatory drugs and/or physical therapy.

Inclusion Criteria - Phase 2

1. 21-65 years.
2. Body Mass Index (BMI) ≤ 35.
3. Up to three treatable joint surface lesion(s), ICRS Grade 3 or 4, located on the medial or lateral femoral condyle(s).
4. Symptomatic total treatable area 1 - 10cm2.
5. Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
6. Stable knee.
7. Non-responsive to a minimum of 3 weeks of conservative treatment, consisting of non-steroidal anti-inflammatory drugs and/or physical therapy.

Exclusion Criteria - Phase 1 \& 2

HYALEX Implant, Surgical Technique, and Lesion Site Exclusions:

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.

Patient Orthopaedic Health Exclusions:

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. Any known systemic cartilage and/or bone disorder, such as but not limited to osteoporosis, chondrodysplasia or osteogenesis imperfecta.
8. A symptomatic musculoskeletal condition in the lower limbs that could impede effectiveness measurements in the target knee.
9. Any known tumor of the treatment knee.
10. Prior radiation therapy to the knee joint.
11. Clinically significant or symptomatic vascular or neurological disorder of the lower extremities affecting gait or function.
12. 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 surgery in the past 6 months on the index knee except for:

   1. Diagnostic knee arthroscopy and/or debridement / chondroplasty, and
   2. Meniscectomy
2. Previous intra-articular injections, including HA and steroids, within the last 3 months prior to the date of surgery.

Where this trial is running

Lodz and 1 other locations

• SPORTO — Lodz, Poland (RECRUITING)
• LIFE Medical Center — Warsaw, Poland (RECRUITING)

Study contacts

• Principal investigator: Marcin Domzalski, MD — SPORTO, Łódź, Poland
• Study coordinator: Chris Cain

Conditions: Cartilage Injury, Knee, Cartilage, Lesion