[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634319":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":43,"collaborators":11,"id":45,"slug":11,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":11,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":11,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"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,"cosmosGeoPoint":37,"geoPoint":42,"contacts":11},"SPORTO","RECRUITING","Lodz","Poland",{"type":38,"coordinates":39},"Point",[40,41],19.47395,51.77058,{"lat":41,"lon":40},{"type":44,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":55,"type":56},20,"ESTIMATED","INTERVENTIONAL",[59],"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.",[62,63,64],"Hallux Valgus","Hallux Limitus","Hallux Rigidus",[66],"Arthritis","2026-04-13",{"date":69,"type":70},"2026-04-20","ACTUAL",{"date":72,"type":70},"2025-10-01",{"date":74,"type":56},"2027-12-31",{"name":5,"class":6},1]