PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials

This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems, and Bonegraft® bone filling materials (synthetic bone grafts and bone cements). The study aims to evaluate short-term (12-month) safety and effectiveness, identify previously unknown side effects, monitor defined complications, and assess risks based on real-world evidence in patients undergoing spinal surgery. All investigated products are used within their intended purpose under routine clinical practice.

NCT Number	NCT07615491
Lead Sponsor	Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co. Collaborators: Bonegraft Biyolojik Malzemeler San. ve Tic. A.S.
Conditions	Degenerative Disc Disease (DDD), Spinal Stenosis, Spondylolisthesis, Spinal Deformities, Spinal Tumors, Spinal Infections, Spinal Trauma, Vertebral Fractures
Enrollment	561 participants
Start Date	2026-04-27
Primary Completion	2028-04-26 (estimated)
Study Completion	2028-09-26 (estimated)
Updated on ClinicalTrials.gov	2026-05-29