RCT on the Efficacy and Safety of Minimally Invasive SAIF Technique vs Spinal Fixation in Unstable Osteoporotic Vertebral Fractures

Osteoporotic vertebral fractures (OVF) represent a significant cause of morbidity, mortality, decreased level of function and quality of life. The most severe OVFs are unstable and in these cases surgical stabilization, with various techniques, is considered necessary to restore the physiological loading capacity of the spine, and allow fast and painless mobilization. Unfortunately, the elderly, osteoporotic patient population poses serious challenges to spinal surgery, due to tissue frailty and frequent comorbidities. The purpose of this study is to evaluate the effectiveness and safety of the SAIF intervention in comparison with multilevel surgical stabilization in participants with unstable OVFs.

NCT Number	NCT07071870
Lead Sponsor	Eva Koetsier MD PhD Collaborators: Prof. Dr. Med. Alessandro Cianfoni, MD PhD, Neurocenter of Southern Switzerland - Ente Ospedaliero Cantonale (EOC)
Conditions	Unstable Osteoporotic Vertebral Compression Fractures
Enrollment	140 participants
Start Date	2027-01-01
Primary Completion	2029-12-31 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-22