The Hyalex First-in-Human Study

Inclusion criteria

- Phase 1

• 21-65 years.
• Body Mass Index (BMI) ≤ 35.
• Singular treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial or lateral femoral condyle.
• Symptomatic, single treatable area 1 - 3.8cm2.
• Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
• Stable knee.
• 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

• 21-65 years.
• Body Mass Index (BMI) ≤ 35.
• Up to three treatable joint surface lesion(s), ICRS Grade 3 or 4, located on the medial or lateral femoral condyle(s).
• Symptomatic total treatable area 1 - 10cm2.
• Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
• Stable knee.
• 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:

• Known allergy to polyurethanes, bone cement, acrylic, or titanium.
• Lack of 2mm of healthy cartilage (ICRS Grade 0 or 1) 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 as defined:
• Hip-knee-ankle (HKA) angle of greater than +/- 5 degrees (varus or valgus malalignment > 5 degrees) on standing X-ray.
• Lack of normally functioning contralateral knee that restricts activity.
• Insufficiency fracture of the femoral condyle or tibial plateau.
• 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.
• Any known systemic cartilage and/or bone disorder, such as but not limited to osteoporosis, chondrodysplasia or osteogenesis imperfecta.
• A symptomatic musculoskeletal condition in the lower limbs that could impede effectiveness measurements in the target knee.
• Any known tumor of the treatment knee.
• Prior radiation therapy to the knee joint.
• Clinically significant or symptomatic vascular or neurological disorder of the lower extremities affecting gait or function.
• 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 surgery in the past 6 months on the index knee except for:

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