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

Study acronym: SAIF
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 31, 2028 to Dec 31, 2029
    • Start date: Jan 1, 2026 to Jan 1, 2027
    • Study completion date: Dec 31, 2029 to Dec 31, 2030
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 Unstable Osteoporotic Vertebral Compression Fractures
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov