[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100415914":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":43,"responsibleParty":306,"collaborators":308,"id":312,"slug":313,"hasResults":314,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":314,"sex":320,"minAge":321,"maxAge":25,"enrollmentInfo":322,"targetDuration":25,"studyType":325,"phases":326,"briefSummary":328,"conditions":329,"keywords":331,"overallStatus":165,"whyStopped":25,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":345},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conservative treatment","ACTIVE_COMPARATOR","Patients that are randomized to the conservative arm of the trial. These patients will not be operated until primary endpoint is reached.\n\nIf necessary, cross-over can occur after primary endpoint is reached.\n\nConservative treatment is considered standard of care.",[13],"Other: Maximal physiotherapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Surgical treatment","Patients randomized to the surgical arm will be operated within 1 week after randomization (if possible within 2 days).\n\nNeurolysis is considered standard of care.",[18],"Procedure: Neurolysis peroneal nerve",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Neurolysis peroneal nerve","The surgical approach for entrapment at the fibular head is usually through a curvilinear incision just distal to the fibular head. The subcutaneous tissue is bluntly dissected, and the common peroneal nerve is identified proximal to the peroneus longus muscle. The peroneal nerve is then released from the surrounding fibrous tissue and fascia. The nerve is decompressed distally as it dives under the peroneus longus muscle. The decompression at this site is essential. Certain authors state that an adequate decompression should extend beyond the bifurcation in the deep and superficial peroneal nerve and should involve cutting the intermuscular septa",[15],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Maximal physiotherapy","Mobilization of ankle and foot, stretching of the calf muscles (prevention of contractures) Tonification of the dorsiflexion- and eversion muscles of the ankle Proprioceptive training Gait rehabilitation Home exercise schedule",[9],[31],{"name":32,"affiliation":33,"role":34},"Tom Theys, M.D.; Ph.D.","Univeristy hospitals of Leuven","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Christophe Oosterbos, M.D.","CONTACT","+3216344290","christopheoosterbos@gmail.com",{"name":32,"role":38,"phone":39,"phoneExt":25,"email":42},"tom.theys@uzleuven.be",[44,63,77,91,106,120,135,148,163,179,193,208,222,236,247,262,275,290],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"AZ Sint-Maarten","NOT_YET_RECRUITING","Mechelen","Antwerpen","2800","Belgium","BE",{"type":53,"coordinates":54},"Point",[55,56],4.47762,51.02574,{"lat":56,"lon":55},[59,62],{"name":60,"role":38,"phone":61,"phoneExt":25,"email":25},"Pieter Jan Van Dyck - Lippens, M.D.","+3215891010",{"name":60,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":64,"status":46,"city":65,"state":48,"zip":66,"country":50,"countryCode":51,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"AZ Turnhout","Turnhout","2300",{"type":53,"coordinates":68},[69,70],4.94471,51.32254,{"lat":70,"lon":69},[73,76],{"name":74,"role":38,"phone":75,"phoneExt":25,"email":25},"Jens Deckers, M.D.","+3214406184",{"name":74,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":78,"status":46,"city":79,"state":48,"zip":80,"country":50,"countryCode":51,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Sint Augustinus","Wilrijk","2610",{"type":53,"coordinates":82},[83,84],4.39513,51.16734,{"lat":84,"lon":83},[87,90],{"name":88,"role":38,"phone":25,"phoneExt":25,"email":89},"Tony Van Havenbergh, M.D.; 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PhD","+322 477 60 12",{"name":246,"role":34,"phone":25,"phoneExt":25,"email":25},"Johnny Duerinck, M.D.; PhD",{"facility":248,"status":165,"city":249,"state":25,"zip":250,"country":50,"countryCode":51,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Ziekenhuis Oost-Limburg, department of neurosurgery","Genk","3600",{"type":53,"coordinates":252},[253,254],5.50082,50.965,{"lat":254,"lon":253},[257,261],{"name":258,"role":38,"phone":259,"phoneExt":25,"email":260},"Frank Weyns, M.D.","+3289326043","frank.weyns@zol.be",{"name":258,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":263,"status":165,"city":264,"state":25,"zip":265,"country":50,"countryCode":51,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"University Hospitals Of Leuven, department of neurosurgery","Leuven","3000",{"type":53,"coordinates":267},[268,269],4.70093,50.87959,{"lat":269,"lon":268},[272,274],{"name":273,"role":38,"phone":39,"phoneExt":25,"email":42},"Tom Theys, M.D., Ph.D.",{"name":32,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":276,"status":165,"city":277,"state":25,"zip":278,"country":50,"countryCode":51,"cosmosGeoPoint":279,"geoPoint":283,"contacts":284},"CHU de Liège, department of neurosurgery","Liège","4000",{"type":53,"coordinates":280},[281,282],5.56749,50.63373,{"lat":282,"lon":281},[285,288],{"name":286,"role":38,"phone":25,"phoneExt":25,"email":287},"Annie Dubuisson, M.D., Ph.D.","a.dubuisson@chuliege.be",{"name":289,"role":34,"phone":25,"phoneExt":25,"email":25},"Annie Dubuisson, M.D.; Ph.D.",{"facility":291,"status":165,"city":292,"state":25,"zip":293,"country":294,"countryCode":295,"cosmosGeoPoint":296,"geoPoint":300,"contacts":301},"Leids Universitair Medisch Centrum, department of neurosurgery","Leiden","2333","Netherlands","NL",{"type":53,"coordinates":297},[298,299],4.49306,52.15833,{"lat":299,"lon":298},[302,305],{"name":303,"role":38,"phone":25,"phoneExt":25,"email":304},"Justus Groen, M.D.","J.L.Groen@lumc.nl",{"name":303,"role":34,"phone":25,"phoneExt":25,"email":25},{"type":307,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[309],{"name":310,"class":311},"Belgian Health Care Knowledge Centre (KCE)","UNKNOWN","100415914","follow-up-and-outcome-of-operative-treatment-with-decompressive-release-of-the-peroneal-nerve-100415914",false,"NCT04695834","Follow-up and Outcome of Operative Treatment With Decompressive Release Of The Peroneal Nerve","A Prospective, Multi-center, Randomized, Parallel-group Controlled Trial to Compare Conservative Versus Surgical Treatment of Foot Drop in Peroneal Nerve Entrapment.","FOOTDROP","Inclusion Criteria:\n\n* Written informed consent to participate in the study must be obtained from the subject or proxy \u002F legal representative prior to initiation of any study-mandated procedure\n* EDX-documented peroneal nerve entrapment with persisting (10 ± 4 weeks) foot drop (MRC-score ≤ 3)\n* Imaging (ultrasound\u002FMRI) performed to exclude a compressive mass\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Subjects with posttraumatic or iatrogenic peroneal nerve injury\n* Subjects with peroneal neuropathy due to a compressive mass (e.g. cyst, tumour)\n* Peroneal nerve entrapment at other sites than the fibular head\n* Patients with mental or physical problems that incapacitate them to participate in a physiotherapy program\n* Psychiatric illness\n* Pregnancy\n* Planned (e)migration within 1 year after randomization to another country\n* Subjects with previous foot drop\n* Permanently bedridden subjects\n* Subjects with neurological or musculoskeletal history which could impact foot drop assessment and\u002For gait analysis (e.g. polyneuropathy, hereditary neuropathy with pressure palsies, critical illness polyneuropathy, previous stroke, ankle surgery, …).","ALL","18 Years",{"count":323,"type":324},182,"ESTIMATED","INTERVENTIONAL",[327],"NA","The FOOT DROP trial is a prospective, multi-center, randomized controlled trial to assess if decompressive surgery for peroneal nerve entrapment is superior to maximal conservative treatment.\n\nPatients with persisting foot drop due to peroneal nerve entrapment will be randomized to either surgery or conservative treatment if foot drop persists 10 +\u002F- 4 weeks after onset of symptoms.\n\nPatients will be evaluated through several questionnaires, evolution of muscle strength and several types of gait assessments. Primary endpoint is the difference in distance covered during the six minute walking test between baseline and 9 months after randomization.",[330],"Peroneal Nerve Entrapment",[332,333,9,334,335],"Peroneal nerve","Neurolysis","Randomised controlled trial","Foot drop","2024-06-28",{"date":338,"type":339},"2024-07-01","ACTUAL",{"date":341,"type":339},"2021-04-28",{"date":343,"type":324},"2028-12-31",{"name":5,"class":6},18]