Spine Bone Cements Outcomes - Post Market Follow-up
Safety and Clinical Performance Assessment of Bone Cements and Injection Systems Used in Spine Surgery - A Post-Market Clinical Follow-Up
Teknimed
500 participants
Sep 4, 2019
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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
- Be considered for treatment with one of the TEKNIMED Spine Range cement comprised in this study
- 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 Criteria9
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Vertebroplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
Kyphoplasty is a procedure in which a special medical-grade cement mixture is injected into a fractured vertebra to relieve pain
Pedicular Screw Augmentation is a procedure in which a special medical-grade cement mixture is injected into pedicular screws in order to augment fixation strength
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06367582