[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634319":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":44,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Hyalex Orthopaedics, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Implantation of HYALEX SLALOM MTP Hemiarthroplasty Implant","EXPERIMENTAL",null,[13],"Device: MTP Hemiarthroplasty",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","MTP Hemiarthroplasty","Implant",[9],[21],{"name":22,"affiliation":23,"role":24},"Marcin Domzalski, MD","SPORTO, Łódź, Poland","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Chris Cain","CONTACT","14084395154","chris.cain@hyalex.com",[32],{"facility":33,"status":34,"city":35,"state":11,"zip":11,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":11},"SPORTO","RECRUITING","Lodz","Poland","PL",{"type":39,"coordinates":40},"Point",[41,42],19.47395,51.77058,{"lat":42,"lon":41},{"type":45,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":57,"type":58},20,"ESTIMATED","INTERVENTIONAL",[61],"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.",[64,65,66],"Hallux Valgus","Hallux Limitus","Hallux Rigidus",[68],"Arthritis","2026-04-13",{"date":71,"type":72},"2026-04-20","ACTUAL",{"date":74,"type":72},"2025-10-01",{"date":76,"type":58},"2027-12-31",{"name":5,"class":6},1]