[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100439984":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":214,"collaborators":217,"id":242,"slug":243,"hasResults":244,"nctId":245,"briefTitle":246,"officialTitle":246,"acronym":29,"eligibilityCriteria":247,"healthyVolunteers":244,"sex":248,"minAge":249,"maxAge":29,"enrollmentInfo":250,"targetDuration":29,"studyType":253,"phases":254,"briefSummary":256,"conditions":257,"keywords":29,"overallStatus":157,"whyStopped":29,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":272},{"fullName":5,"class":6},"Prometei Pain Rehabilitation Center","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Targeted Muscle Reinnervation (TMR)","ACTIVE_COMPARATOR","The surgical procedure comprises three steps: preparation of the donor nerve, identification of a motor branch to the targeted muscle, and nerve coaptation. To prepare the donor nerve, the surgeon will identify the nerve with a painful neuroma and resect the neuroma up to healthy fascicles. Next, the surgeon will identify a motor branch to a nearby target muscle and will confirm muscle contraction using a hand-held nerve stimulator. The motor branch to the target muscle will be transected as close as possible to its entry point without tension. In the final step, the previous nerve stump from which the neuroma was resected will be transferred and coapted to the newly severed motor branch that innervates the target muscle and secured by 2-3 non-resorbable monofilament sutures. The surgery time is approximately 2-3 hours and it takes place in the hospital.",[13],"Procedure: Targeted Muscle Reinnervation (TMR)",{"label":15,"type":10,"description":16,"interventionNames":17},"Regenerative Peripheral Nerve Interface (RPNI)","The RPNI procedure involves construction of a residual peripheral nerve split into several nerve fascicles and implanted into free skeletal muscle grafts. First, the surgeon identifies the nerve with a painful neuroma and resect the neuroma up to healthy fascicles. Then, a longitudinal intraneural dissection will be performed exposing its fascicles. Next, autologous muscle grafts will be harvested from a healthy donor site, and the dissected nerve stumps will be placed parallel to the muscle fibers. The nerve stump will be secured to the muscle graft, thereafter the graft will be wrapped around the nerve stump and anchored in the folded graft, thus creating an RPNI. This will be repeated for each fascicle obtained from splitting the transected nerve. Lastly, the RPNIs will be placed in a protected area. The surgery time is approximately 2-3 hours and it takes place in the hospital.",[18],"Procedure: Regenerative Peripheral Nerve Interface (RPNI)",{"label":20,"type":10,"description":21,"interventionNames":22},"Standard neuroma treatment, neuroma excision, and muscle burying","The standard neuroma treatment, also called neuroma transposition, includes excision of the terminal neuroma and burying the nerve into an adjacent deep muscle.The standard neuroma treatment entails the excision of the terminal neuroma and then implanting the nerve into an adjacent muscle. Firstly, the surgeon will identify the nerve with a painful neuroma and thereafter resect the neuroma up to healthy fascicles. Next, the surgeon will identify a nearby muscle which is not involved in joint motion and has limited output opportunities for the nerve. The nerve will then be channeled at least 1 cm inside the muscle without applying any tension to it and secured by 1-2 non-resorbable monofilament sutures. The identified nerve with the painful neuroma will not be treated with any additional therapy than the resection (e.g., diathermy, pharmacotherapy, crushing, etc.). The surgery time is approximately 1-2 hours and it takes place in the hospital.",[23],"Procedure: Standard neuroma treatment, neuroma excision, and muscle burying",[25,30,33],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"PROCEDURE","Surgical procedure used to rewire injured proximal nerves to motor nerves directly innervating an otherwise redundant target muscle.",[9],null,{"type":26,"name":15,"description":31,"armGroupLabels":32,"otherNames":29},"Surgical procedure where the the nerve is split into fascicles and wrapped in free muscle grafts.",[15],{"type":26,"name":20,"description":34,"armGroupLabels":35,"otherNames":29},"Surgical procedure where the neuroma is excised and the nerve stump is buried in an adjacent deep muscle.",[20],[37],{"name":38,"affiliation":5,"role":39},"Max Ortiz Catalan, PhD","PRINCIPAL_INVESTIGATOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":29,"email":44},"CONTACT","+46708461065","maxortizc@outlook.com",[46,68,85,102,119,140,155,175,195],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Northwestern Memorial Hospital","NOT_YET_RECRUITING","Chicago","Illinois","60611","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-87.65005,41.85003,{"lat":58,"lon":57},[61,64,65],{"name":62,"role":42,"phone":29,"phoneExt":29,"email":63},"Jason Ko, MD, PhD","jason.ko@nm.org",{"name":62,"role":39,"phone":29,"phoneExt":29,"email":29},{"name":66,"role":67,"phone":29,"phoneExt":29,"email":29},"Gregory Dumanian, MD, PhD","SUB_INVESTIGATOR",{"facility":69,"status":48,"city":70,"state":71,"zip":72,"country":52,"countryCode":53,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":55,"coordinates":74},[75,76],-71.05977,42.35843,{"lat":76,"lon":75},[79,82,83],{"name":80,"role":42,"phone":29,"phoneExt":29,"email":81},"Ian Valerio, MD, PhD","IVALERIO@mgh.harvard.edu",{"name":80,"role":39,"phone":29,"phoneExt":29,"email":29},{"name":84,"role":67,"phone":29,"phoneExt":29,"email":29},"Kyle Eberlin, MD, PhD",{"facility":86,"status":48,"city":87,"state":88,"zip":89,"country":52,"countryCode":53,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"University of Michigan Health System","Ann Arbor","Michigan","48109",{"type":55,"coordinates":91},[92,93],-83.74088,42.27756,{"lat":93,"lon":92},[96,99,100],{"name":97,"role":42,"phone":29,"phoneExt":29,"email":98},"Paul Cederna, MD, PhD","cederna@med.umich.edu",{"name":97,"role":39,"phone":29,"phoneExt":29,"email":29},{"name":101,"role":67,"phone":29,"phoneExt":29,"email":29},"Theodore Alexander Kung, MD, PhD",{"facility":103,"status":48,"city":104,"state":29,"zip":29,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Dandenong Hospital, Monash Health","Melbourne","Australia","AU",{"type":55,"coordinates":108},[109,110],144.96332,-37.814,{"lat":110,"lon":109},[113,116,117],{"name":114,"role":42,"phone":29,"phoneExt":29,"email":115},"Michael Lo, MD, PhD","mlo@bigpond.net.au",{"name":114,"role":39,"phone":29,"phoneExt":29,"email":29},{"name":118,"role":67,"phone":29,"phoneExt":29,"email":29},"Michael Leung, MD, PhD",{"facility":120,"status":48,"city":121,"state":122,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"University of Alberta Hospital","Edmonton","Alberta","AB T6G 2B7","Canada","CA",{"type":55,"coordinates":127},[128,129],-113.46871,53.55014,{"lat":129,"lon":128},[132,135,136,138],{"name":133,"role":42,"phone":29,"phoneExt":29,"email":134},"Adil Ladak, MD, PhD","aladak@ualberta.ca",{"name":133,"role":39,"phone":29,"phoneExt":29,"email":29},{"name":137,"role":67,"phone":29,"phoneExt":29,"email":29},"Hollie Power, MD, PhD",{"name":139,"role":67,"phone":29,"phoneExt":29,"email":29},"Jacqueline Hebert, MD, PhD",{"facility":141,"status":48,"city":142,"state":29,"zip":29,"country":143,"countryCode":144,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Worker Hospital","Santiago","Chile","CL",{"type":55,"coordinates":146},[147,148],-70.64827,-33.45694,{"lat":148,"lon":147},[151,154],{"name":152,"role":42,"phone":29,"phoneExt":29,"email":153},"Juan Manuel Breyer, MD, PhD","jmbreyer@hotmail.com",{"name":152,"role":39,"phone":29,"phoneExt":29,"email":29},{"facility":156,"status":157,"city":158,"state":159,"zip":160,"country":161,"countryCode":162,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Rizzoli Orthopedic Institute","RECRUITING","Bologna","Emilia-Romagna","40136","Italy","IT",{"type":55,"coordinates":164},[165,166],11.33875,44.49381,{"lat":166,"lon":165},[169,172,173],{"name":170,"role":42,"phone":29,"phoneExt":29,"email":171},"Paolo Sassu, MD, PhD","sassupaolo@gmail.com",{"name":170,"role":39,"phone":29,"phoneExt":29,"email":29},{"name":174,"role":67,"phone":29,"phoneExt":29,"email":29},"Francesca Pedrini, MD",{"facility":176,"status":48,"city":177,"state":178,"zip":179,"country":180,"countryCode":181,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Sahlgrenska University Hospital","Mölndal","Västra Götaland County","431 80","Sweden","SE",{"type":55,"coordinates":183},[184,185],12.01378,57.6554,{"lat":185,"lon":184},[188,191,193],{"name":189,"role":42,"phone":29,"phoneExt":29,"email":190},"Emily Pettersen, MSc","emily-pettersen@outlook.com",{"name":192,"role":39,"phone":29,"phoneExt":29,"email":29},"Carina Reinholdt, MD, PhD",{"name":194,"role":67,"phone":29,"phoneExt":29,"email":29},"Hannes Granberg, MD",{"facility":196,"status":48,"city":197,"state":29,"zip":29,"country":198,"countryCode":199,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"NHS Lothian, NHS Clyde & Greater Glasgow, and NHS Grampian","Edinburgh","United Kingdom","UK",{"type":55,"coordinates":201},[202,203],-3.19648,55.95206,{"lat":203,"lon":202},[206,209,210,212],{"name":207,"role":42,"phone":29,"phoneExt":29,"email":208},"Aidan Roche, MD, PhD","aidan.roche@ed.ac.uk",{"name":207,"role":39,"phone":29,"phoneExt":29,"email":29},{"name":211,"role":67,"phone":29,"phoneExt":29,"email":29},"Andrew Hart, MD, PhD",{"name":213,"role":67,"phone":29,"phoneExt":29,"email":29},"Lorraine Harrington, MD, PhD",{"type":39,"investigatorFullName":215,"investigatorTitle":216,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Max Ortiz Catalan","Professor",[218,221,223,225,227,229,231,233,234,236,237,240],{"name":219,"class":220},"Vastra Gotaland Region","OTHER_GOV",{"name":222,"class":6},"Göteborg University",{"name":224,"class":6},"Istituto Ortopedico Rizzoli",{"name":226,"class":6},"Hospital del Trabajador de Santiago",{"name":228,"class":220},"NHS Lothian",{"name":230,"class":6},"NHS Greater Clyde and Glasgow",{"name":232,"class":220},"NHS Grampian",{"name":47,"class":6},{"name":235,"class":6},"University of Michigan",{"name":69,"class":6},{"name":238,"class":239},"Dandenong Hospital","UNKNOWN",{"name":241,"class":6},"University of Alberta","100439984","surgical-treatments-for-postamputation-pain-100439984",false,"NCT05009394","Surgical Treatments for Postamputation Pain","Inclusion Criteria:\n\n* The participant must have a major limb amputation.\n* The participant is ≥ 18 years old at the time of consent.\n* The participant must be in generally good health to undergo a surgical intervention, as per the clinical investigator's opinion.\n* Time since the last amputation must be over a year at the time of consent.\n* The participant must have an average residual limb pain score equal or greater than 4 on the Numerical Rating Scale (NRS, 0-10) after the baseline period.\n* If the participant has been prescribed pharmacological treatments for pain, there must be no variations in dosage (steady consumption) for at least 1 month before the screening visit.\n* If the participant has been prescribed non-pharmacological treatments for pain, such as spinal cord stimulation, transcutaneous electrical nerve stimulation, and mirror therapy, the treatment must have ended at least 1 month before the screening visit.\n* The participant must have a stable prosthetic fitting for at least a month before the screening visit.\n* The participant has a sufficient understanding of the language in which the assessments will be conducted, as per the clinical investigator's opinion.\n\nExclusion Criteria:\n\n* Neurological or other conditions that affect nerve regeneration for the nerve to be treated.\n* Active infection in the residual limb.\n* Prior RPNI or TMR surgery of the nerve to be treated (with painful neuroma) to address postamputation pain.\n* Mental disorders (e.g., schizophrenia, paranoia, psychosis, etc.), reluctance, or language difficulties that result in difficulty understanding the meaning of study participation.\n* Ongoing participation in a clinical study that the clinical investigator deems detrimental to participation in this study.","ALL","18 Years",{"count":251,"type":252},110,"ESTIMATED","INTERVENTIONAL",[255],"NA","This is a double-blind randomised controlled trial (RCT) which compares the effectiveness of three surgical techniques for alleviating residual limb pain (RLP), neuroma pain and phantom limb pain (PLP). The three surgical treatments are Targeted Muscles Reinnervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), and an active control (neuroma excision and muscle burying). Patients will be follow-up for 4 years.",[258,259,260,261,262],"Residual Limb Pain","Amputation Neuroma","Phantom Limb Pain","Pain, Neuropathic","Pain, Nerve","2025-01-07",{"date":265,"type":266},"2025-01-09","ACTUAL",{"date":268,"type":266},"2023-06-20",{"date":270,"type":252},"2029-06",{"name":5,"class":6},9]