protocolSection identificationModule nctId: NCT06354543, orgStudyIdInfo id: CA01-TK-ARTHRO, briefTitle: Arthroplasty Cements Outcomes - A Post-market Follow-up, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-12-16, primaryCompletionDateStruct date: 2035-12, completionDateStruct date: 2045-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Teknimed, class: INDUSTRY, descriptionModule briefSummary: A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all Teknimed Arthroplasty range of products: CEMFIX® and GENTAFIX® bone cements families and CEMSTOP® cement restrictor, and all their private labels.Teknimed bone cements and cement restrictor are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting.The study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site., conditionsModule conditions: Arthroplasty, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 1050, type: ESTIMATED, armsInterventionsModule interventions name: Cemented joint arthroplasty, outcomesModule primaryOutcomes measure: Survival rate, primaryOutcomes measure: Superficial and/or deep postoperative infection rate., secondaryOutcomes measure: Pain Level, secondaryOutcomes measure: Patients' satisfaction, secondaryOutcomes measure: Restoration of function, secondaryOutcomes measure: Evaluation of function and radiological outcomes, secondaryOutcomes measure: Complications rate, secondaryOutcomes measure: Antalgic consumption, secondaryOutcomes measure: Restoration of function, secondaryOutcomes measure: Restoration of function, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique du Vivarais, status: RECRUITING, city: Aubenas, state: Auvergne-rhône-alpes, zip: 07200, country: France, contacts name: Michel MILAIRE, MD, role: CONTACT, email: michel.milaire@yahoo.com, contacts name: Michel MILAIRE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.62006, lon: 4.38994, locations facility: Clinique du Val d'Ouest, status: RECRUITING, city: Ecully, state: Auvergne-rhône-alpes, zip: 69130, country: France, contacts name: Benoît GIRAUD, MD, role: CONTACT, email: b.giraud@chirortho-valdouest.fr, contacts name: Benoît GIRAUD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.77726, lon: 4.77481, locations facility: Cabinet de consultation, status: RECRUITING, city: Evreux, state: Eure, zip: 27000, country: France, contacts name: Edouard DECRETTE, MD, role: CONTACT, email: decrette.edouard@gmail.com, contacts name: Edouard DECRETTE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.02414, lon: 1.15082, locations facility: Clinique du Dr Henri Guillard, status: RECRUITING, city: Coutances, state: Normandie, zip: 50200, country: France, contacts name: Olivier COSSART, MD, role: CONTACT, email: o.cossart@hotmail.fr, contacts name: Olivier COSSART, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.05, lon: -1.43333, locations facility: Clinique de l'Atlantique, status: RECRUITING, city: Puilboreau, state: Nouvelle-aquitaine, zip: 17138, country: France, contacts name: Cédric BOUQUET, MD, role: CONTACT, email: docteurbouquet@gmail.com, contacts name: Cédric BOUQUET, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.1862, lon: -1.11797, locations facility: Hôpital Européen Marseille, status: RECRUITING, city: Marseille, state: Provence-alpes-cote D'azur, zip: 13003, country: France, contacts name: Maxime MUNIER, MD, role: CONTACT, email: dr.maxime.munier@gmail.com, contacts name: Maxime MUNIER, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Ospedale Santissima Annunziata, status: RECRUITING, city: Cento, state: Emilie-Romagne, zip: 44042, country: Italy, contacts name: Luca CASTAGNINI, MD, role: CONTACT, email: luca.castagnini@ausl.fe.it, contacts name: Luca CASTAGNINI, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.73099, lon: 11.28716, locations facility: Instituto Ortopedico Rizzoli, status: RECRUITING, city: Bologna, state: Émilie-Romagne, zip: 40136, country: Italy, contacts name: Stefano ZAFFAGNINI, MD, role: CONTACT, email: stefano.zaffagnini@unibo.it, contacts name: Stefano ZAFFAGNINI, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False