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RCT on the Efficacy and Safety of Minimally Invasive SAIF Technique vs Spinal Fixation in Unstable Osteoporotic Vertebral Fractures
Sponsor: Eva Koetsier MD PhD
Summary
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.
Official title: A Multicenter Prospective Randomized Controlled Non-Inferiority Trial Comparing Minimally Invasive SAIF Vertebral Reconstruction Technique Versus Spinal Fixation in Unstable Osteoporotic Vertebral Compression Fractures
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-01-01
Completion Date
2029-12-31
Last Updated
2025-07-17
Healthy Volunteers
No
Interventions
Stent-screw Assisted Internal Fixation (SAIF)
Implanting vertebral body stents (VBS), followed by insertion of percutaneous, fenestrated, cement-augmented pedicular screws
Surgical stabilization
Spinal fixation with cement augmented pedicle screws bridging the fractured vertebra
Locations (1)
EOC Lugano
Lugano, Canton Ticino, Switzerland