[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602306":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":11,"responsibleParty":30,"collaborators":11,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":11,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":11,"enrollmentInfo":41,"targetDuration":11,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":51,"overallStatus":59,"whyStopped":11,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":11},{"fullName":5,"class":6},"Bioretec Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Hammertoe correction surgery with Mg-based DrillPins","EXPERIMENTAL",null,[13],"Device: Implant Mg-based RemeOs™ drillpins",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Implant Mg-based RemeOs™ drillpins","This is a first-in-human clinical feasibility study of a novel absorbable magnesium-zinc-calcium alloy DrillPin (RemeOs™) for internal fixation during surgical correction of hammertoe deformities in adult patients. The implant is investigational, not CE-marked, and represents an alternative to conventional stainless steel or titanium K-wires commonly used in toe correction surgery.\n\nThe RemeOs™ DrillPin is designed to provide mechanical stability during osteotomy healing and gradually resorbs over 2-3 years, potentially eliminating the need for secondary implant removal.\n\nThe study focuses on evaluating safety, performance, and implant resorption using standardized clinical and radiographic assessments. The DrillPin is made from the same magnesium alloy (ZX00) as the CE-marked RemeOs™ Screw, which has demonstrated clinical safety and performance in prior applications.",[9],[21],{"name":22,"affiliation":23,"role":24},"Patrick Holweg, Prof. Dr.","Department of Orthopaedics and Trauma, Medical University of Graz","PRINCIPAL_INVESTIGATOR",[26],{"name":22,"role":27,"phone":28,"phoneExt":11,"email":29},"CONTACT","+43 316 385-0","p.holweg@medunigraz.at",{"type":31,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100602306","mg-alloy-drillpins-in-hammertoe-deformity-correction-100602306",false,"NCT07121790","Mg Alloy DrillPins in Hammertoe Deformity Correction","The Use of Magnesium (Mg)-Based Absorbable DrillPins in Hammertoe Deformity Correction: a Feasibility Study","Inclusion Criteria:\n\n* Hammertoe deformity of the lesser toes, with or without accompanying surgery of a hallux valgus deformity\n* Written informed consent of the participant\n* Female and male patients aged 18 years and more\n* Subject has been informed of the nature of the study, agrees to participate and signs the approved consent form\n* Subject is able and willing to comply with all assessments in the study.\n* Female patients in childbearing age perform a pregnancy test prior to inclusion\n\nExclusion Criteria:\n\n* Pathological bone lesions (e.g., bone cysts or osteomyelitis)\n* Underlying diseases (kidney diseases, diabetes mellitus)\n* Chronic alcoholics\n* Severe mental illness\n* Pregnant or breastfeeding women\n* Inability or unwillingness to give informed consent","ALL","18 Years",{"count":42,"type":43},20,"ESTIMATED","INTERVENTIONAL",[46],"NA","This is a prospective, single-arm clinical feasibility study evaluating the safe application of a novel lean absorbable magnesium-zinc-calcium alloy (ZX00) drill pin (RemeOs™ DrillPin) for the surgical correction of hammertoe deformities. A total of 20 adult patients will be enrolled. All participants will receive the investigational implant without a comparator or control group. The study focuses on feasibility, safety, and functional outcomes following implantation.",[49,50],"Hammertoe","Hammer Toe Syndrome",[52,53,54,55,56,57,58],"deformity","device","Hammertoe surgery","absorbable implant","osteotomy fixation","DrillPin","RemeOs","NOT_YET_RECRUITING","2025-08-07",{"date":62,"type":63},"2025-08-14","ACTUAL",{"date":65,"type":43},"2025-08",{"date":67,"type":43},"2029-12",{"name":5,"class":6}]