[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hallux-limitus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hallux-limitus":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":5},"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"]