SAIF
A Multicenter Prospective Randomized Controlled Non-Inferiority Trial Comparing Minimally Invasive SAIF Vertebral Reconstruction Technique Versus Spinal Fixation in Unstable Osteoporotic Vertebral Compression Fractures
Sponsor study identifier
interventional
140
1 country
1
Study Start
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 30, 2025
Actual (reported)July 17, 2025
Actual (reported)January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in the Quality of Life questionnaire of the European Foundation of Osteoporosis (QUALEFFO) score.
The QUALEFFO score is patient-reported and comprises 41 items on five domains: pain, physical function, social function, general health perception, and mental function. All answers are standardized so that 1 represents the best and 5 (or 3, or 4) represents the worst quality of life. The total score is calculated by summing all answers of questions 1-41. The raw total score ranges from 41 to 205 and this is transformed to scores from 0 to 100. A high score indicates a poor quality of life.
at 12 months from baseline.
restoration of angular kyphosis at index level
pre-operative and at 1, 6 and 12 months follow up
vertebral body height restoration
Baseline and 1 day after the intervention
global kyphosis/lordosis
pre-operative and at 1, 6 and 12 months follow up
Global Sagittal Balance
pre-operative and at 1, 6 and 12 months follow up
length of operation
Perioperative
Safety outcomes
up to 12 months.
SAIF technique, performed by percutaneous access, consists of, implanting vertebral body stents (VBS) under fluoroscopic guidance, followed by insertion of percutaneous, fenestrated, cement-augmented pedicular screws that act as anchors to the posterior elements for the cement/stent complex. The screws reduce the risk of stent mobilization in a non-intact vertebral body (VB) cortical shell and bridge middle column and pedicular fractures.
Spinal stabilization with augmented or non-augmented pedicle screws bridging the fractured vertebra, with or without (percutaneous) cement augmentation of the fractured vertebra, with or without reconstruction of the anterior column via anterior or lateral approach.
Implanting vertebral body stents (VBS), followed by insertion of percutaneous, fenestrated, cement-augmented pedicular screws
Spinal fixation with cement augmented pedicle screws bridging the fractured vertebra
EOC Lugano
Lugano, Canton Ticino, 6900, Switzerland
Cianfoni A, Koetsier E, van Kuijk SMJ, Kimman M, Di Caterino F, Kaelin A, Hirsch JA, Willems PC. Multicentre prospective randomised controlled non-inferiority trial on the efficacy and safety of minimally invasive SAIF vertebral reconstruction technique versus spinal fixation in unstable osteoporotic vertebral compression fractures: a protocol. BMJ Open. 2026 Jul 17;16(7):e108564. doi: 10.1136/bmjopen-2025-108564.
First Submitted
April 30, 2025
First Posted
July 17, 2025
Study Start
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 31, 2029
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 22, 2026
Record last verified: 2026-04
De-identified individual participant data, including baseline characteristics, imaging data and clinical outcomes, will be made available upon reasonable request to the corresponding author following publication. Data will be shared with researchers who provide a methodologically sound proposal, subject to approval and after signing a data access agreement
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Source: ClinicalTrials.gov.
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