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Bone Substitutes Outcomes - Post Market Follow-up
Sponsor: Teknimed
Summary
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.
Official title: Safety and Clinical Performance Assessment of Bone Substitutes Used for Bone Voids Filling - A Post-Market Clinical Follow-Up
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
425
Start Date
2021-09-16
Completion Date
2032-09-30
Last Updated
2025-09-09
Healthy Volunteers
No
Conditions
Interventions
Bone defect
Bone grafting is a procedure where damaged bones can be repaired or rebuilt using transplanted bone from another source. Sources for transplant bone include the patient (autograft), a cadaver (allograft) or synthetic bone.
Spine fusion
Spinal fusion is a surgery procedure that reinforces your back structure and stability by linking two vertebrae together
Cage filling
Intervertebral fusion with cages is a surgical procedure used to stabilize the spine by fusing adjacent vertebrae. The cages, typically made of materials like titanium or plastic, and pre-filled with bone graft substitutes are placed between the vertebrae to maintain the proper spacing and alignment.
Locations (6)
Pôle Rachis Hôpital Privé d'Eure et Loir
Mainvilliers, Eure et Loir, France
Hôpital Joseph Ducuing
Toulouse, Haute Garonne, France
Clinique Médipole Garonne
Toulouse, Haute Garonne, France
CHRU Brabois
Nancy, Meurthe et Moselle, France
Clinique du Pré
Le Mans, Sarthe, France
OCM Klinik GmbH
München, Bavaria, Germany