The Hyalex First-in-Human 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 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.