protocolSection identificationModule nctId: NCT06374342, orgStudyIdInfo id: SO01-TK-SUBSTITUTES, briefTitle: BONE SUBSTITUTES OUTCOMES, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-09-16, primaryCompletionDateStruct date: 2026-09-16, completionDateStruct date: 2032-09-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, 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 Bone Substitute range of products: CERAFORM, TRIHA+, NANOGEL, and all their private labels.TEKNIMED bone substitutes 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, prospective observational study. Patients will be followed as per local standard medical care of the sites., conditionsModule conditions: Bone Resorption, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 425, type: ESTIMATED, armsInterventionsModule interventions name: Bone defect, interventions name: Spine fusion, interventions name: Cage filling, outcomesModule primaryOutcomes measure: Successful bone repair, secondaryOutcomes measure: Alleviation of Pain, secondaryOutcomes measure: Bone reconstruction, secondaryOutcomes measure: Well-being, secondaryOutcomes measure: Patient satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule 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 Joseph Ducuing, status: RECRUITING, city: Toulouse, state: Haute Garonne, zip: 31000, country: France, contacts name: Gérard GIORDANO, MD, role: CONTACT, email: ortho.giordano@gmail.com, contacts name: Gérard GIORDANO, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Clinique Médipole Garonne, status: RECRUITING, city: Toulouse, state: Haute Garonne, zip: 31100, country: France, contacts name: Dominique VARDON, MD, role: CONTACT, email: dr-dominique.vardon@orange.fr, contacts name: Dominique VARDON, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, locations facility: CHRU Brabois, status: RECRUITING, city: Nancy, state: Meurthe Et Moselle, zip: 54000, country: France, contacts name: Didier MAINARD, MD, role: CONTACT, email: didier.mainard@univ-lorraine.fr, contacts name: Didier MAINARD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.68439, lon: 6.18496, locations facility: Clinique du Pré, status: RECRUITING, city: Le Mans, state: Sarthe, zip: 72000, country: France, contacts name: Jean-Patrick RAKOVER, MD, role: CONTACT, phone: 02 43 77 54 21, email: jeanpatrickrakover@me.com, contacts name: Jean-Patrick RAKOVER, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.0, lon: 0.2, locations facility: OCM Klinik GmbH, status: RECRUITING, city: München, state: Bavière, zip: D-81369, country: Germany, contacts name: Markus SCHROEDEL, MD, role: CONTACT, email: Markus.schroedel@ocm-muenchen.de, contacts name: Markus SCHROEDEL, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.13743, lon: 11.57549, hasResults: False