Spine Bone Cements Outcomes - Post Market Follow-up

Launched by TEKNIMED · Apr 11, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Spine Bone Cements Outcomes - Post Market Follow-up," is looking at the safety and effectiveness of certain bone cements used to treat vertebral fractures, which are common in conditions like osteoporosis. The study will gather information about products from the TEKNIMED Spine range, including SPINEFIX, HIGH V+, OPACITY+, and F20. While these products have been on the market for over a decade and have already shown good results in previous studies, this trial aims to further confirm their performance and safety by collecting data from real-life patient experiences.

To participate, you need to be at least 18 years old and willing to allow the use of your medical data for this study. You may qualify if you're being treated with one of the TEKNIMED products or if you have had surgery with these cements since January 2016. However, certain conditions, like severe heart or lung issues or unstable fractures, may prevent you from being included. Participants will be followed by their healthcare providers as per standard medical care, and the study is currently recruiting patients. This means that if you decide to join, you'll be contributing to understanding how these bone cements work in everyday clinical settings.

Gender

ALL

Eligibility criteria

• 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.