Clinical Trials Detalhe

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.

Vertebral Fracture

Compression Fracture

Osteoporotic Fractures

Inclusion Criteria: * Be 18 years or older * Be willing to sign an informed consent approved by Ethic Committee (when applicable) or not being opposed to the use of their clinical data in the study o For prospective inclusion: * Be considered for treatment with one of the TEKNIMED Spine Range cement comprised in this study o For retrospective inclusion: * Have undergone a surgery with a TEKNIMED Spine Range cement between the 1st of January 2016 and the date of the site initiation visit. * Be informed of the study and not being opposed to the use of their clinical data in the study or be willing to sign an informed consent during the first follow-up visit following the site initiation (when applicable). Exclusion Criteria: Patients presenting one of the following conditions will not be included (contraindications per IFU): * Procedures other than those stated in the INDICATIONS section * Coagulation disorders, or severe cardiopulmonary disease * Unstable vertebral fractures * Compromise of the vertebral body or of the pedicle walls * Hypersensitivity or allergy to one of the constituents of the product * Patient clearly improving on more conservative treatment * Prophylactic use in spinal metastatic or osteoporotic patients with no evidence of acute fracture * Paediatric patients and pregnant or breast-feeding women.