| NCT ID | NCT06344481 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hyalex Orthopaedics, Inc. |
| Condition | Cartilage Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-03-07 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2024-03-07 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The Hyalex First-in-Human Study is a prospective, multicenter, open-label, single-arm, 2-phase, first-in-human 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.
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.
Contact & Investigator
Marcin Domzalski, MD
PRINCIPAL INVESTIGATOR
SPORTO, Łódź, Poland
Frequently Asked Questions
Who can join the NCT06344481 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Cartilage Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06344481 currently recruiting?
Yes, NCT06344481 is actively recruiting participants. Contact the research team at chris.cain@hyalex.com for enrollment information.
Where is the NCT06344481 trial being conducted?
This trial is being conducted at Lodz, Poland, Warsaw, Poland.
Who is sponsoring the NCT06344481 clinical trial?
NCT06344481 is sponsored by Hyalex Orthopaedics, Inc.. The principal investigator is Marcin Domzalski, MD at SPORTO, Łódź, Poland. The trial plans to enroll 15 participants.