[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hyalex Orthopaedics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100634319","the-hyalex-mtp-study-100634319",false,"NCT07538141","The Hyalex MTP Study","The Hyalex First-in-Human Study - A Prospective, Single-Arm, Feasibility Study of the HYALEX SLALOM MTP Hemiarthroplasty Implant","Inclusion Criteria:\n\n1. 21-75 years;\n2. Body Mass Index (BMI) ≤ 38;\n3. Degenerative or post-traumatic arthritis of the first metatarsal joint with ICRS grade 2, 3, or 4;\n4. Pre-operative VAS pain score of \\>40;\n5. Presence of good bone stock, without need for bone graft\n\nExclusion Criteria:\n\n1. Known allergy to polyurethanes, bone cement, acrylic, or titanium;\n2. Due to anatomy and\u002For lesion location, inability to position the implant flush or slightly proud relative to the articular surface precluding proper device placement;\n3. Lack of 2mm of vital bone on all sides of implant site;\n4. Cartilage lesions on the phalanx of ICRS Grade 3 - 4 opposite the lesion intended for treatment;\n5. Additional ipsilateral lower limb (hip, knee, ankle, or foot) pathology that requires active treatment (e.g., surgery, brace);\n6. Bilateral degenerative or post-traumatic arthritis of the MTP joints that would require simultaneous treatment of both MTP joints;\n7. Previous cheilectomy resulting in inadequate bone stock;\n8. Diagnosis of gout;\n9. Hallux varus to any degree or hallux valgus \\>20;\n10. Hyper mobility at proximal metatarsal joint;\n11. Interphalangeal angle \\>15","ALL","21 Years","75 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","The HYALEX SLALOM MTP Hemiarthroplasty System consists of a synthetic implant designed to replace the distal metatarsal surface of the great toe for treatment of arthritis . The system is composed of the HYALEX MTP Implant and instrumentation. The implant consists of the HYALEX Cartilage material bonded to a titanium backing.",[27,28,29],"Hallux Valgus","Hallux Limitus","Hallux Rigidus",[31],"Arthritis","RECRUITING","2026-04-13",{"date":35,"type":36},"2026-04-20","ACTUAL",{"date":38,"type":36},"2025-10-01",{"date":40,"type":21},"2027-12-31",{"name":42,"class":43},"Hyalex Orthopaedics, Inc.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100544424","the-hyalex-pivotal-study-100544424","NCT06368700","The HYALEX Pivotal Study","The HYALEX Freestyle™ Resurfacing System Pivotal Study: A Multicenter, Single-Arm, Pivotal Study of the HYALEX Freestyle Resurfacing Implant","Inclusion Criteria (Phase 1):\n\n1. 22-70 years.\n2. Body Mass Index (BMI) ≤ 40.\n3. Up to two treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial and\u002For lateral femoral condyle.\n4. 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 \u002F condyle.\n5. Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.\n6. Ligamentously stable knee.\n7. 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.\n\nExclusion Criteria:\n\nHYALEX Implant, Surgical Technique, and Lesion Site Exclusions:\n\n1. Known allergy to polyurethanes, bone cement, acrylic, or titanium.\n2. Lack of 2mm of cartilage (ICRS Grade 0 to 2) and 2mm of vital bone wall on all sides of the implant site.\n3. Osteochondral defect affecting subchondral bone more than 11mm in depth from adjacent non-defect articular surface.\n4. Bipolar cartilage lesions involving patellar or tibial lesions ICRS Grade 3 - 4 opposite the lesion intended for treatment.\n5. Insufficient bone stock or bone density determined intra-operatively preventing implant press fit.\n\nPatient Orthopaedic Health Exclusions:\n\n1. Kellgren and Lawrence (KL) grade 3 or 4 on standing radiographs.\n2. Hip-knee-ankle (HKA) angle of greater than +\u002F- 8 degrees (varus or valgus malalignment \\> 8 degrees) on standing X-ray.\n3. Lack of normally functioning contralateral knee that restricts activity.\n4. Recent Osteochondritis Dissecans within 1 year.\n5. Diagnosis of a concomitant knee injury which the investigator believes may interfere with study participation or confound effectiveness assessment.\n6. Untreated ACL and\u002For PCL deficiency or complex ligamentous instability of the study knee according to IKDC Grade C (abnormal) or D (severely abnormal).\n\nPrevious Surgery and Intervention Exclusions:\n\n1. Previous surgical cartilage treatment in the index knee within the last 6 months\n2. Previous intra-articular injections, including HA and steroids, within the last 3 months prior to the date of surgery.\n\nPatient Overall Health and Health History Exclusions:\n\n1. Any known history of inflammatory arthropathy or untreated or uncontrolled crystal-deposition arthropathy.\n2. Current cigarette smoker or user of other nicotine products.\n3. Known Type 1 or Type 2 insulin-dependent diabetes mellitus.\n4. Currently undergoing immunosuppressive therapy or long-term steroid use (corticosteroid, excluding inhalers) or within 3 months prior to surgery.","22 Years","70 Years",{"count":55,"type":21},85,[24],"A multicenter, open-label, single-arm, pivotal study to evaluate the safety and effectiveness of the HYALEX Freestyle Resurfacing System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment, will be enrolled in the study and undergo implantation of the HYALEX Freestyle Resurfacing Implant.",[59],"Damaged Chondral or Osteochondral Area",{"date":61,"type":36},"2026-04-16",{"date":63,"type":36},"2024-04-04",{"date":65,"type":21},"2028-12",{"name":42,"class":43},4,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100542562","the-hyalex-first-in-human-study-100542562","NCT06344481","The Hyalex First-in-Human Study","A Prospective, Multicenter, Single-Arm, 2-Phase First-in-Human Feasibility Study of the HYALEX® Cartilage System","Inclusion Criteria - Phase 1\n\n1. 21-65 years.\n2. Body Mass Index (BMI) ≤ 35.\n3. Singular treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial or lateral femoral condyle.\n4. Symptomatic, single treatable area 1 - 3.8cm2.\n5. Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.\n6. Stable knee.\n7. Non-responsive to a minimum of 3 weeks of conservative treatment, consisting of non-steroidal anti-inflammatory drugs and\u002For physical therapy.\n\nInclusion Criteria - Phase 2\n\n1. 21-65 years.\n2. Body Mass Index (BMI) ≤ 35.\n3. Up to three treatable joint surface lesion(s), ICRS Grade 3 or 4, located on the medial or lateral femoral condyle(s).\n4. Symptomatic total treatable area 1 - 10cm2.\n5. Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.\n6. Stable knee.\n7. Non-responsive to a minimum of 3 weeks of conservative treatment, consisting of non-steroidal anti-inflammatory drugs and\u002For physical therapy.\n\nExclusion Criteria - Phase 1 \\& 2\n\nHYALEX Implant, Surgical Technique, and Lesion Site Exclusions:\n\n1. Known allergy to polyurethanes, bone cement, acrylic, or titanium.\n2. Lack of 2mm of healthy cartilage (ICRS Grade 0 or 1) and 2mm of vital bone wall on all sides of the implant site.\n3. Osteochondral defect affecting subchondral bone more than 11mm in depth from adjacent non-defect articular surface.\n4. Bipolar cartilage lesions involving patellar or tibial lesions ICRS Grade 3 - 4 opposite the lesion intended for treatment.\n5. Insufficient bone stock or bone density determined intra-operatively preventing implant press fit.\n\nPatient Orthopaedic Health Exclusions:\n\n1. Kellgren and Lawrence (KL) grade 3 or 4 on standing radiographs as defined:\n2. Hip-knee-ankle (HKA) angle of greater than +\u002F- 5 degrees (varus or valgus malalignment \\> 5 degrees) on standing X-ray.\n3. Lack of normally functioning contralateral knee that restricts activity.\n4. Insufficiency fracture of the femoral condyle or tibial plateau.\n5. Recent Osteochondritis Dissecans within 1 year.\n6. Diagnosis of a concomitant knee injury which the investigator believes may interfere with study participation or confound effectiveness assessment.\n7. Any known systemic cartilage and\u002For bone disorder, such as but not limited to osteoporosis, chondrodysplasia or osteogenesis imperfecta.\n8. A symptomatic musculoskeletal condition in the lower limbs that could impede effectiveness measurements in the target knee.\n9. Any known tumor of the treatment knee.\n10. Prior radiation therapy to the knee joint.\n11. Clinically significant or symptomatic vascular or neurological disorder of the lower extremities affecting gait or function.\n12. Untreated ACL and\u002For PCL deficiency or complex ligamentous instability of the study knee according to IKDC Grade C (abnormal) or D (severely abnormal).\n\nPrevious Surgery and Intervention Exclusions:\n\n1. Previous surgery in the past 6 months on the index knee except for:\n\n   1. Diagnostic knee arthroscopy and\u002For debridement \u002F chondroplasty, and\n   2. Meniscectomy\n2. Previous intra-articular injections, including HA and steroids, within the last 3 months prior to the date of surgery.","65 Years",{"count":77,"type":21},15,[24],"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.",[81],"Cartilage Injury",[83,84,85],"Knee","Cartilage","Lesion","2025-06-26",{"date":88,"type":36},"2025-06-29",{"date":90,"type":36},"2024-03-07",{"date":92,"type":21},"2026-09",{"name":42,"class":43},2,""]