RCT on the Efficacy and Safety of Minimally Invasive SAIF Technique vs Spinal Fixation in Unstabl… (NCT07071870) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
RCT on the Efficacy and Safety of Minimally Invasive SAIF Technique vs Spinal Fixation in Unstable Osteoporotic Vertebral Fractures
Switzerland140 participantsStarted 2027-01-01
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* one to two unstable OVFs\* type OF 3-5\*\* as assessed on CT scan, located between T2 and L5, of age \<3 months or with persistent edema on STIR, or with pseudarthrosis, at the index level
* patients reporting pain upon mobilization
* a diagnosis of osteoporosis, based on a DEXA T-score ≤ -2.5, or on a spontaneous thoracolumbar vertebral fracture or a vertebral fracture caused by minor trauma
* able to read and speak the official language of the region of the site,
* informed consent
* additional OVF without unstable features (OF 1-2) allowed \*\* OF-Classification
Exclusion Criteria:
* compressive neurologic symptoms such as myelopathy or radiculopathy with motor deficit
* acute infection
* spinal malignancy
* comorbid severe psychiatric conditions
* known or suspected non-compliance, drug or alcohol abuse
* known hypersensitivity or allergy to the investigational product
* inability to follow the procedures of the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Quality of Life questionnaire of the European Foundation of Osteoporosis (QUALEFFO) score.