[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100439891":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":81,"collaborators":83,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":10,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":10,"enrollmentInfo":99,"targetDuration":10,"studyType":102,"phases":10,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Medstar Health Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Regenerative Peripheral Nerve Interface",null,"symptomatic neuroma is excised, and the end of the peripheral nerve is implanted into a small denervated free muscle graft harvested from the patient",[13],"Procedure: Regenerative Peripheral Nerve Interface (RPNI) surgery",{"label":15,"type":10,"description":16,"interventionNames":17},"Traction Neurectomy","simple excision and traction neurectomy",[18],"Procedure: Traction Neurectomy",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"PROCEDURE","Regenerative Peripheral Nerve Interface (RPNI) surgery","Surgeons will perform neuroma resection and RPNI creation using a free muscle graft from the brachioradialis muscle harvested through a small separate incision",[9],{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":10},"Surgeons will perform neuroma resection and traction neurectomy,",[15],[29],{"name":30,"affiliation":31,"role":32},"Aviram M Giladi, MS, MD","Medstar Union Memorial Hospital","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Isaac C Fleming","CONTACT","410-554-2486","ike.c.fleming@medstar.net",[40,63],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The Curtis National Hand Center at Medstar Union Memorial Hospital","RECRUITING","Baltimore","Maryland","21218","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-76.61219,39.29038,{"lat":52,"lon":51},[55,57,61],{"name":56,"role":36,"phone":37,"phoneExt":10,"email":38},"Ike Fleming",{"name":58,"role":36,"phone":59,"phoneExt":10,"email":60},"Alessandra Butanis","410-554-2123","alessandra.l.butanis@medstar.net",{"name":62,"role":32,"phone":10,"phoneExt":10,"email":10},"Aviram M Gildai, MD, MS",{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":46,"countryCode":47,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"University of Michigan Plastic Surgery","NOT_YET_RECRUITING","Ann Arbor","Michigan","48109",{"type":49,"coordinates":70},[71,72],-83.74088,42.27756,{"lat":72,"lon":71},[75,79],{"name":76,"role":36,"phone":77,"phoneExt":10,"email":78},"Jenni Hammill, M.P.H","570-559-7912","jenberry@med.umich.edu",{"name":80,"role":32,"phone":10,"phoneExt":10,"email":10},"Theodore A Kung, MD",{"type":82,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[84,87],{"name":85,"class":86},"United States Department of Defense","FED",{"name":88,"class":6},"University of Michigan","100439891","regenerative-peripheral-nerve-interfaces-to-treat-painful-digit-and-hand-neuromas-after-amputation-100439891",false,"NCT05008185","Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation","Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation: A Prospective Observational Trial\"","Inclusion Criteria:\n\n* 18 years or older\n* History of unilateral digit, multiple digit, or partial hand amputation\n* Discrete neuroma pain on clinical exam\n* Following standard of care (SOC), confirmation through a local block and\u002For ultrasound imaging will be performed if indicated\n* Must be seen by a hand therapist for at least 6-week trial of desensitization therapy\n\nExclusion Criteria:\n\n* Patients with previous surgical treatment for symptomatic neuromas of the digits or hand\n* Patients with other major injuries more proximal in the ipsilateral extremity that cause chronic pain or functional loss\n* women pregnant at time of enrollment\n* prisoners\n* adults who are unable to consent",true,"ALL","18 Years",{"count":100,"type":101},80,"ESTIMATED","OBSERVATIONAL","This study is being done to demonstrate the effectiveness of Regenerative Peripheral Nerve Interfaces (RPNI) surgery in treating symptomatic neuromas of the hand and digits following amputation compared to standard of care using a Prospective, Observational Trial",[105],"Neuroma",[105,107,108,109],"Neuroma Pain","Finger Amputation","Hand Amputation","2024-11-26",{"date":112,"type":113},"2024-11-29","ACTUAL",{"date":115,"type":113},"2021-10-05",{"date":117,"type":101},"2025-08",{"name":5,"class":6},2]