[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535911":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":25,"centralContacts":30,"locations":37,"responsibleParty":145,"collaborators":35,"id":147,"slug":35,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":148,"sex":154,"minAge":155,"maxAge":35,"enrollmentInfo":156,"targetDuration":35,"studyType":159,"phases":160,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":133,"whyStopped":35,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Elsan","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Experimental group","Operated patients with positive results for their pre-operative microbiological samples.",[12],"Other: This study is with minimal risk and minimal constraints due to the addition of questionnaires",{"label":14,"type":6,"description":15,"interventionNames":16},"Control group","Operated patients with negative results for their pre-operative microbiological samples.",[12],[18],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"This study is with minimal risk and minimal constraints due to the addition of questionnaires","In this study, the specific procedures compared to routine care are :\n\n* Considering the addition of questionnaires, this study will be prospective. Due to the use of bacteriological samples, it is considered as a minimal-risk research.\n* The research procedure involves a bacteriological analysis of operative elements (sutures placed during the first intervention, the product of tendon debridement, and the subacromial bursa (cleaning product)) used during the re-intervention. These usually discarded operative samples are collected for bacteriological analysis.\n* Antibiotic treatment cannot be prescribed immediately after the surgery and during the first month following this re-intervention (time for biofilm formation). As per the protocol, even a positive sample should not lead to the initiation of systematic antibiotic therapy. In the case of identification of a pathogenic microorganism, antibiotic therapy will be prescribed, leading to discontinuation of the study.",[14,9],[23,24],"Microbiological analysis of samples collected from operated patients: in the presence of UPC, it does not influence the postoperative course","No antibiotics are prescribed during the first month after the operation.",[26],{"name":27,"affiliation":28,"role":29},"Maxime ANTONI, MD","Clinique de l'Orangerie-Strasbourg","STUDY_DIRECTOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Albatoul ZAKARIA, PhD","CONTACT","0033 6 49 77 17 52",null,"zakaria@elsan.care",[38,54,67,79,92,105,118,131],{"facility":39,"status":40,"city":41,"state":35,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Hôpital privé La Châtaigneraie ELSAN","NOT_YET_RECRUITING","Beaumont","63110","France",{"type":45,"coordinates":46},"Point",[47,48],3.08294,45.75165,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":35,"phoneExt":35,"email":53},"METAIS Pierre, MD","pierremetais@mac.com",{"facility":55,"status":40,"city":56,"state":35,"zip":57,"country":43,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Hôpital privé Saint-Martin","Caen","14050",{"type":45,"coordinates":59},[60,61],-0.35912,49.18585,{"lat":61,"lon":60},[64],{"name":65,"role":33,"phone":35,"phoneExt":35,"email":66},"Franck DORDAIN, MD","fdordain@gmail.com",{"facility":68,"status":40,"city":69,"state":35,"zip":70,"country":43,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Clinique Louis Pasteur","Essey-lès-Nancy","54270",{"type":45,"coordinates":72},[73,74],6.22691,48.705,{"lat":74,"lon":73},[77],{"name":78,"role":33,"phone":35,"phoneExt":35,"email":35},"Adrien JACQUOT, MD",{"facility":80,"status":40,"city":81,"state":35,"zip":82,"country":43,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Santy-Lyon-Ramsay","Lyon","69008",{"type":45,"coordinates":84},[85,86],4.84789,45.74906,{"lat":86,"lon":85},[89],{"name":90,"role":33,"phone":35,"phoneExt":35,"email":91},"Philippe COLLOTTE, MD","docteurcollotte@gmail.com",{"facility":93,"status":40,"city":94,"state":35,"zip":95,"country":43,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Clinique d'occitanie ELSAN","Muret","31600",{"type":45,"coordinates":97},[98,99],1.32541,43.45998,{"lat":99,"lon":98},[102],{"name":103,"role":33,"phone":35,"phoneExt":35,"email":104},"Benjamin ADAMCZEWSKI, MD","benjamin.adamczewski@gmail.com",{"facility":106,"status":40,"city":107,"state":35,"zip":108,"country":43,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"ICR-Kantys","Nice","06000",{"type":45,"coordinates":110},[111,112],7.26608,43.70313,{"lat":112,"lon":111},[115],{"name":116,"role":33,"phone":35,"phoneExt":35,"email":117},"Mikaël CHELLI, MD","dr.chelli@icr-nice.com",{"facility":119,"status":40,"city":120,"state":35,"zip":121,"country":43,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Santé Atlantique ELSAN","Saint-Herblain","44800",{"type":45,"coordinates":123},[124,125],-1.651,47.21154,{"lat":125,"lon":124},[128],{"name":129,"role":33,"phone":35,"phoneExt":35,"email":130},"Yves BOUJU, MD","yves.bouju@gmail.com",{"facility":132,"status":133,"city":134,"state":35,"zip":35,"country":43,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Clinique de l'Orangerie","RECRUITING","Strasbourg",{"type":45,"coordinates":136},[137,138],7.74553,48.58392,{"lat":138,"lon":137},[141],{"name":142,"role":33,"phone":143,"phoneExt":35,"email":144},"Maxime Antony, MD","0033 6 50 35 21 12","antoni@epaule-coude-orangerie.fr",{"type":146,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100535911",false,"NCT06257979","Unexpected Positive Cultures in Rotator Cuff Revision Surgery","Unexpected Positive Cultures in Rotator Cuff Revision Surgery: Significance and Influence on Outcomes and Tendon Healing","POCICO","Inclusion Criteria:\n\n* Patient, male or female, aged 18 or over\n* Patient requiring re- intervention for Rotator Ruff Revision Surgery for non-healing of the same tendons after a first intervention (delay \\\u003C2 years)\n* Patient requiring arthroscopy\n* Patient having had realized a MRI of the shoulder in the 6 previous months\n* Affiliate participant or beneficiary of a social security scheme\n* Participant having been informed and not having objected to the use of their data\n\nExclusion Criteria:\n\n* Patient with at least one clinical sign of infection (fever, redness)\n* Patient with a new distant rupture on a healed cuff (\\> 3 years)\n* Patient with a history of shoulder surgery other than initial Rotator Ruff Surgery\n* Patient having received antibiotic treatment in the 2 weeks preceding inclusion\n* Participant in another research\n* Participant in a period of exclusion from another research still in progress at the time of inclusion\n* Protected participant: an adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision\n* Pregnant, breastfeeding or parturient woman\n* Participant hospitalized without consent","ALL","18 Years",{"count":157,"type":158},132,"ESTIMATED","INTERVENTIONAL",[161],"NA","In the context of rotator cuff re-intervention, the impact of Unexpected Positive Cultures (UPC) is not documented, and their management has not been studied, particularly regarding indications for antibiotic therapy, which is currently not a consensus.\n\nA prospective interventional study will be implemented to compare the results of non-randomized patient samples, whether positive or negative, taken during rotator cuff re-intervention. The objective is to assess whether these samples do not affect clinical outcomes and tendon healing rates.",[164],"Rotator Cuff Repair",[166,167],"Unexpected Positive Cultures (UPC)","Revision cuff repair surgery (RCR)","2024-06-17",{"date":170,"type":171},"2024-06-18","ACTUAL",{"date":173,"type":171},"2024-02-27",{"date":175,"type":158},"2028-03-15",{"name":5,"class":6},8]