[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571913":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":137,"collaborators":25,"id":139,"slug":140,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":141,"sex":147,"minAge":148,"maxAge":25,"enrollmentInfo":149,"targetDuration":25,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":160,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"fullName":5,"class":6},"Poitiers University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CryoNeurotomy (CN)","EXPERIMENTAL","Cryoneurotomy procedure",[13],"Procedure: Cryoneurotomy (CN)",{"label":15,"type":16,"description":17,"interventionNames":18},"Surgical neurotomy (SN)","ACTIVE_COMPARATOR","Surgical neurotomy procedure",[19],"Procedure: Surgical neurotomy (SN)",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Surgical neurotomy will be performed under general anesthesia according to the previous description. Muscle relaxant drugs will not be used in order to prevent any interference with the intraoperative electrical stimulation.\n\nThe patient will be placed in a prone position and a vertical cutaneous incision will be made at the popliteal fossa location.\n\nThe tibial nerve will be dissected and the motor nerve branches of the soleus, gastrocnemius, tibialis posterior and flexor hallucis longus will be identified with intraoperative tripolar electrical stimulation. The selected motor nerve branches will be partially sectioned over a 5mm length under the microscope. The extent of nerve section will be determined according to the degree of spasticity and to the intraoperative residual muscular contraction under electrical stimulation",[15],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Cryoneurotomy (CN)","After the use of an aseptic technique with 2% chlorhexidine, betadine application and a local anesthesia with lidocaine 1% (3ml), percutaneous cryoneurotomy will be performed with METRUM CRYOFLEX device guided by ultrasound with 1.2mm cryoprobe at -89°C placed through a #16 angio guide. Electrical stimulation will be performed to confirm tibial nerve contact at 0.8 mV.\n\nThe ice ball will be repositioned to two spots along the nerve. Each lesion will be treated for 2min cryoneurolysis at -89°C, followed by 2min without freezing (passive defreezing period) and 2min of cryoneurolysis at -89°C, based on cryotherapy for pain management.",[9],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Romain DAVID, MD","CONTACT","+33 5 49 44 44 54","romain.david@chu-poitiers.fr",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Corinne LORRAIN","+33 5 49 44 39 30","corinne.lorrain@chu-poitiers.fr",[41,59,73,84,98,108,122],{"facility":42,"status":43,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Hôpital Raymond Pointcarré","RECRUITING","Garches","92380","France","FR",{"type":49,"coordinates":50},"Point",[51,52],2.18232,48.84226,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":57,"phoneExt":25,"email":58},"Marjorie SALGA, MD","+33 1 47 10 77 16","marjorie.salga@aphp.fr",{"facility":60,"status":43,"city":61,"state":25,"zip":62,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"CHRU Montpellier","Montpellier","34295",{"type":49,"coordinates":64},[65,66],3.87635,43.61093,{"lat":66,"lon":65},[69],{"name":70,"role":33,"phone":71,"phoneExt":25,"email":72},"Flavia COROIAN, MD","+33 467338717","fo-coroian@chu-montpellier.fr",{"facility":74,"status":43,"city":75,"state":25,"zip":76,"country":46,"countryCode":47,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"C.H.U. Poitiers","Poitiers","86000",{"type":49,"coordinates":78},[79,80],0.34348,46.58261,{"lat":80,"lon":79},[83],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},{"facility":85,"status":43,"city":86,"state":25,"zip":87,"country":46,"countryCode":47,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"CHU Rennes","Rennes","35000",{"type":49,"coordinates":89},[90,91],-1.67431,48.11109,{"lat":91,"lon":90},[94],{"name":95,"role":33,"phone":96,"phoneExt":25,"email":97},"Charles GUIGNANS, MD","+33 2 99 28 42 18","Charles.GUIGNANS@chu-rennes.fr",{"facility":99,"status":43,"city":86,"state":25,"zip":87,"country":46,"countryCode":47,"cosmosGeoPoint":100,"geoPoint":102,"contacts":103},"Pôle Saint-Hélier",{"type":49,"coordinates":101},[90,91],{"lat":91,"lon":90},[104],{"name":105,"role":33,"phone":106,"phoneExt":25,"email":107},"Anne-Laure ROY, MD","+33 2 99 29 53 08","AnneLaure.ROY@fondationsainthelier.com",{"facility":109,"status":43,"city":110,"state":25,"zip":111,"country":46,"countryCode":47,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"CHU Saint-Etienne","Saint-Etienne","44055",{"type":49,"coordinates":113},[114,115],4.39,45.43389,{"lat":115,"lon":114},[118],{"name":119,"role":33,"phone":120,"phoneExt":25,"email":121},"Etienne OJARDIAS, MD","+33 4 77 12 04 61","Etienne.Ojardias@chu-st-etienne.fr",{"facility":123,"status":124,"city":125,"state":25,"zip":126,"country":46,"countryCode":47,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Hôpital Purpan","NOT_YET_RECRUITING","Toulouse","31059",{"type":49,"coordinates":128},[129,130],1.44367,43.60426,{"lat":130,"lon":129},[133],{"name":134,"role":33,"phone":135,"phoneExt":25,"email":136},"Camille CORMIER, MD","+33 5 61 77 86 88","cormier.c@chu-toulouse.fr",{"type":138,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100571913","evaluation-of-percutaneous-cryoneurotomy-compared-to-surgical-open-neurotomy-for-the-management-of-equinovarus-foot-deformity-in-patients-with-refractory-lower-limb-spasticity-after-stroke-100571913",false,"NCT06726434","Evaluation of Percutaneous Cryoneurotomy Compared to Surgical Open Neurotomy for the Management of Equinovarus Foot Deformity in Patients With Refractory Lower Limb Spasticity After Stroke","Evaluation of Percutaneous Cryoneurotomy Compared to Surgical Open Neurotomy for the Management of Equinovarus Foot Deformity in Patients With Refractory Lower Limb Spasticity After Stroke: a Multicenter, Randomized Controlled, Non-inferiority Trial","CRYOSTROKE","Inclusion Criteria:\n\n* Age ≥18 years old.\n* Patient with spastic equinovarus foot as a result of stroke in chronic phase (\\>6 months).\n* Patient with positive perineural motor block test with or without complete correction of spastic equinus and non-persistence of 40° equinus.\n* Patient eligible for surgical neurotomy for varus equinus foot.\n* Patient presenting no cognitive impairment or major depression (Mini Mental State Examination\\>20, Hospital Anxiety and Depression (HAD\\\u003C11)).\n* Absence of active psychosis or history of serious psychotic illness requiring hospitalization\n* Patient understanding and accepting the constraints of the study.\n* Patient covered by French national health insurance.\n* Patient who has given their written consent to the study after having received clear information.\n\nExclusion Criteria:\n\n* Patient with previous nerve procedures such as chemical neurolysis with alcohol, cryoneurotomy, or any surgery at the same anatomical site.\n* Patient with any neurological pathology different from the one responsible for the spasticity.\n* Patient with botulinum toxin in lower limb injection during the last 90 days before intervention.\n* Patient with anti-spastic treatment (baclofene) up 3 days before block test.\n* Patient with total deficit of valgus muscles.\n* Patient with equinus foot \\> 40° (retractions\u002Fankylosis).\n* Surgical and anesthetic contra-indications (severe uncontrolled coagulation disorder, active infection).\n* Cryoneurotomy contra-indications (cold intolerance, cryoglobulinemia, cryofibrinogenemia, Raynaud's phenomena, venous thromboemolism (\\\u003C 3 months if superficial, \\\u003C 6 months if deep), hypothyreosis, cold urticari, local disorders of blood supply, considerable anemia, cachexia, hypothermia, cancer disease, infection, coagulopathy…).).\n* Subject requiring closer protection, i.e. minors, pregnant women, nursing mothers, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection (temporary or permanent guardianship and, subject to subordination), and finally patients in an emergency setting.\n* Pregnant woman, nursing mother, woman of childbearing potential not using effective contraception (hormonal\u002Fbarrier: oral, parenteral, percutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy).","ALL","18 Years",{"count":150,"type":151},114,"ESTIMATED","INTERVENTIONAL",[154],"NA","CRYOSTROKE study is designed :\n\n* to compare the efficacy and safety of percutaneous CryoNeurotomie (CN) versus surgical neurotomy (SN) on spasticity, 90 days after intervention, in post-stroke patients presenting with spastic equinovarus foot and,\n* to ensure that potential clinical effect\u002Fsafety remain stable within time, with a 12-month follow-up.",[157,158,159],"Stroke","Equinovarus Foot","Refractory Lower Limb Spasticity",[161,162,163,164,165],"surgical neurotomy","CryoNeurotomy","spasticity","cryoneurolysis","percutaneous cryoneurolysis","2026-02-24",{"date":168,"type":169},"2026-02-25","ACTUAL",{"date":171,"type":169},"2025-07-09",{"date":173,"type":151},"2029-06-09",{"name":5,"class":6},7]