protocolSection identificationModule nctId: NCT06367582, orgStudyIdInfo id: CV01-TK-SPINE, briefTitle: SPINE BONE CEMENTS OUTCOMES, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-09-04, primaryCompletionDateStruct date: 2029-09-04, completionDateStruct date: 2039-09-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, 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 Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all their private labels.TEKNIMED bone cements are legacy products, some marketed for more than 10 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, prospective observational study. Patients will be followed as per local standard medical care of the sites., conditionsModule conditions: Vertebral Fracture, conditions: Compression Fracture, conditions: Osteoporotic Fractures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Vertebroplasty (VP), interventions name: Kyphoplasty (KP), interventions name: Pedicular Screw Augmentation (PSA), outcomesModule primaryOutcomes measure: Alleviation of Pain, secondaryOutcomes measure: Restoration of quality of life, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Stabilization of vertebrae, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Antalgic Consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU HautePierre, status: RECRUITING, city: Strasbourg, state: Bas-Rhin, zip: 67200, country: France, contacts name: Vincent LAMAS, MD, role: CONTACT, email: vincent.lamas@chru-strasbourg.fr, contacts name: Vincent LAMAS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, locations facility: Pôle Rachis Hôpital Privé d'Eure et Loir, status: RECRUITING, city: Mainvilliers, state: Eure Et Loir, zip: 28300, country: France, contacts name: Jean MEYBLUM, MD, role: CONTACT, email: jeanmeyblum@hotmail.com, contacts name: Jean MEYBLUM, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.45003, lon: 1.45607, locations facility: Hôpital Toulouse Purpan, status: RECRUITING, city: Toulouse, state: Haute Garonne, zip: 31130, country: France, contacts name: Marie FARUCH, MD, role: CONTACT, email: faruch.m@chu-toulouse.fr, contacts name: Marie FARUCH, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Pôle Sud Santé, status: RECRUITING, city: Le Mans, state: Sarthe, zip: 72100, country: France, contacts name: Alexandru NITULESCU, MD, role: CONTACT, email: alexandru_orto@yahoo.com, contacts name: Alexandru NITULESCU, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.0, lon: 0.2, locations facility: Centre Hospitalier Métropole Savoie, status: RECRUITING, city: Chambéry, state: Savoie, zip: 73000, country: France, contacts name: Cristian VASILE, MD, role: CONTACT, email: cristian.vasile@ch-metropole-savoie.fr, contacts name: Cristian VASILE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.56667, lon: 5.93333, locations facility: Hospitale Cruz Vermelha Portuguesa, status: RECRUITING, city: Lisbonne, zip: 1549-008, country: Portugal, contacts name: Miguel CORDEIRO, MD, role: CONTACT, phone: 914655121, email: miguel.cordeiro@hcvp.com.pt, contacts name: Miguel CORDEIRO, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.71667, lon: -9.13333, locations facility: Clínica Teknon Instituto de neurociencias, status: RECRUITING, city: Barcelona, zip: 08022, country: Spain, contacts name: Daniel CRUZ MIRANDA, MD, role: CONTACT, email: dr.jdcruz@gmail.com, contacts name: David BOSCH GARCIA, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Neurotraumatologico, status: RECRUITING, city: Granada, zip: 18013, country: Spain, contacts name: Fernando RUIZ SANTIAGO, MD, role: CONTACT, email: ferusan12@gmail.com, contacts name: Fernando RUIZ SANTIAGO, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.18817, lon: -3.60667, locations facility: Hospital Clínico Universitario Virgen de la Arrixaca, status: RECRUITING, city: Murcia, zip: 30120, country: Spain, contacts name: Gonzalo DE PACO TUDELA, MD, role: CONTACT, email: gonzalodepaco@gmail.com, contacts name: Gonzalo DE PACO TUDELA, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.98704, lon: -1.13004, locations facility: Fundacio Assistencial Mutua de Terrassa - Edifici Estació, status: RECRUITING, city: Terrassa, zip: 08222, country: Spain, contacts name: David BOSCH GARCIA, MD, role: CONTACT, email: dbosch@mutuaterrassa.com, contacts name: David BOSCH GARCIA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.56667, lon: 2.01667, locations facility: Hospital de Zafra, status: RECRUITING, city: Zafra, zip: 06300, country: Spain, contacts name: Félix PANTA ANTON, MD, role: CONTACT, email: pantafelix74@gmail.com, contacts name: Félix PANTA ANTON, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.41667, lon: -6.41667, locations facility: Institute of Traumatology and Orthopaedics, status: RECRUITING, city: Kiev, zip: 1601, country: Ukraine, contacts name: Andrii SHEVCHUK, MD, role: CONTACT, email: fasti@i.ua, contacts name: Andrii SHEVCHUK, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.45466, lon: 30.5238, hasResults: False