Unstable Osteoporotic Vertebral Compression FracturesSAIFNCT07071870
RCT on the Efficacy and Safety of Minimally Invasive SAIF Technique vs Spinal Fixation in Unstable Osteoporotic Vertebral Fractures
A study testing Stent-screw Assisted Internal Fixation (SAIF) and Surgical stabilization in people with Unstable Osteoporotic Vertebral Compression Fractures, run by Eva Koetsier MD PhD at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Unstable Osteoporotic Vertebral Compression Fractures
- What is being tested?
- Stent-screw Assisted Internal Fixation (SAIF) and Surgical stabilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2027to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
EOC Lugano
Lugano, Canton Ticino, 6900
Eva Koetsier, MD PhD LLM, 0041(0)783388933, Eva.Koetsier@eoc.ch
Alessandro Cianfoni, MD PhD, 0041 (0)918116027, Alessandro.Cianfoni@eoc.ch
About this study
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
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.
Read the detailed description
Osteoporosis is an increasing health problem worldwide with an enormous economic burden for society. Osteoporotic vertebral fractures (OVF) represent a significant cause of morbidity, mortality, decreased level of function and quality of life. Stable fractures with controllable pain can be managed conservatively, and only those that remain painful despite conservative treatment can be treated with minimally-invasive measures of vertebral augmentation (VA). At the other end of the spectrum, the most severe OVFs are unstable. In these cases standard vertebral augmentation techniques are generally considered an under-treatment and surgical stabilization, with various techniques, is considered necessary to restore the physiological loading capacity of the spine, and allow fast and painless mobilization. Unfortunately, this elderly, osteoporotic patient population poses serious challenges to spinal surgery, due to tissue frailty and frequent comorbidities. More specifically, all the surgical stabilization techniques include rigid posterior fixation of multiple spinal segments, but the reduced bone mechanical properties of osteoporotic patients can lead to hardware implant failure, new fractures, complications, and need of re-intervention.
On the other hand, treatment and reinforcement of the anterior spinal column, that should enhance posterior stabilization, requires a more invasive surgical approach, which carries a significant rate of complications and prolonged recovery times in this elderly population.
A recently described minimally-invasive interventional technique, called Stent-screw Assisted Internal Fixation (SAIF), can reconstruct, stabilize and restore axial load capability of the vertebral body affected by severe fractures, potentially obviating the need of a surgical multi-level rigid construct.
The study seeks primarily to determine whether the SAIF intervention is not inferior to surgical stabilization in improving quality of life in subjects with unstable OVFs at one year follow-up.
The principle secondary objective of this study is to evaluate whether the effect of the SAIF intervention on the radiological outcome is not inferior to surgical stabilization in subjects with OVFs.
Other secondary objectives are to compare both treatments in terms of safety, length of operation, blood loss, days of hospitalization postoperatively, pain, the intake of analgesics, disability and cost-effectiveness.
The total expected number of patients to randomized is 140, 70 per group. This ensures 80% power to test the hypothesis that SAIF is not inferior to surgical stabilization in increasing quality of life measured with the QUALEFFO questionnaire, assuming a standard deviation of 16 points, with a non-inferiority margin of 8 points. This also ensures over 90% power to exclude a non-inferiority margin of 4 degrees of kyphosis correction. The alpha for testing is set at 5%.
Estimated duration for the main investigational plan will be 60 months (from start of screening of first subject to last subject processed and finishing the study).
- Being tested
- Stent-screw Assisted Internal Fixation (SAIF), Surgical stabilization
- Keywords
- Stent-screw Assisted Internal Fixation (SAIF), Surgical stabilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent-screw Assisted Internal Fixation (SAIF)Procedure or surgery
Also called SAIF
Implanting vertebral body stents (VBS), followed by insertion of percutaneous, fenestrated, cement-augmented pedicular screws
Surgical stabilizationProcedure or surgery
Spinal fixation with cement augmented pedicle screws bridging the fractured vertebra
| Study group | Role | What they receive |
|---|---|---|
| Stent-screw Assisted Internal Fixation (SAIF) | Experimental | 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. Receives: Procedure: Stent-screw Assisted Internal Fixation (SAIF) |
| Surgical stabilization | Active comparator | 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. Receives: Procedure: Surgical stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 12 months from baseline.
Secondary outcomes (11)
restoration of angular kyphosis at index level
Restoration of angular kyphosis at index level (local kyphotic angle LKA and vertebral kyphotic angle VKA) comparing pre-operative with postoperative standing radiographs (local) and full spine standing radiographs at follow-up.
This will be quantified as kyphosis correction at the index level in degrees. The non-inferiority margin is determined at 4 degrees.
Measured: pre-operative and at 1, 6 and 12 months follow up
vertebral body height restoration
Vertebral body height restoration (anterior VB, mid VB, post VB, or ratio of these) comparing pre- and post-operative computed tomography (CT) scan.
Measured: Baseline and 1 day after the intervention
global kyphosis/lordosis
Calculation of the Cobb angle at the thoracic and lumbar segments using a full spine stanting radiograph
Measured: pre-operative and at 1, 6 and 12 months follow up
Global Sagittal Balance
Calculation of Sagittal Vertical Axis assessed with full spine stanting radiographs
Measured: pre-operative and at 1, 6 and 12 months follow up
length of operation
minutes from skin insertion to skin closure during the tratment
Measured: Perioperative
blood loss
blood transfusion from the beginning of the intervention to discharge
Measured: up to 1 week
days of hospitalization postoperatively
the number of days between the intervention and discharge. In case of outpatient (day surgery), the days of hospitalization are zero
Measured: up to a week
back pain
back pain measured with the numeric rating score (NRS): 11-point NRS ranging from 0 (no pain at all) to 10 (the worst imaginable pain). A score of zero (0) will indicate that the patient is pain free, while a score of ten (10) will indicate that they are experiencing the worst pain imaginable.
Measured: at baseline and at 1, 3, 6 and 12 months follow up
the intake of analgesics using the Medication Quantification Scale (MQS).
The score is calculated for each medication by taking a consensus-based detriment weight for a given pharmacologic class and multiplying it by a score for dosage. The calculated values for each medication are then summed for a total MQS score
Measured: at baseline and at 1, 3, 6 and 12 months follow up
disability using Roland-Morris disability questionnaire (RMDQ)
24 items that assess functional status over the past 24 hours in patients with back pain.
The total score ranges from 0 to 24:
0 = no disability 24 = maximum disability related to low back pain. A change in 2-3 points on the RDQ is considered the minimum clinically important change.
Measured: at 1, 3, 6 and 12 months follow up
cost-effectiveness
two outcomes are combined: the quality-adjusted life year (QALY) that takes into account the quantity (longevity/mortality) and the health-related quality of life (HRQoL), and costs that include health care related costs, costs to patients and family, and costs related to paid and unpaid home care.
Measured: up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unstable Osteoporotic Vertebral Compression FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eva Koetsier MD PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. Med. Alessandro Cianfoni, MD PhD, Neurocenter of Southern Switzerland - Ente Ospedaliero Cantonale (EOC)
- Responsible party
- Sponsor-investigator, Eva Koetsier MD PhD, Ospedale Regionale di Lugano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071870
- Sponsor's protocol ID
- 2021-02396
- Acronym
- SAIF
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 42468948
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07071870
- Acronym / sponsor ID
- SAIF / 2021-02396
- Keywords
- Stent-screw Assisted Internal Fixation (SAIF), Surgical stabilization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Eva Koetsier MD PhDUniversity, hospital or other
- Collaborators
- Prof. Dr. Med. Alessandro Cianfoni, MD PhD, Neurocenter of Southern Switzerland - Ente Ospedaliero Cantonale (EOC)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Osteoporosis is an increasing health problem worldwide with an enormous economic burden for society. Osteoporotic vertebral fractures (OVF) represent a significant cause of morbidity, mortality, decreased level of function and quality of life. Stable fractures with controllable pain can be managed conservatively, and only those that remain painful despite conservative treatment can be treated with minimally-invasive measures of vertebral augmentation (VA). At the other end of the spectrum, the most severe OVFs are unstable. In these cases standard vertebral augmentation techniques are generally considered an under-treatment and surgical stabilization, with various techniques, is considered necessary to restore the physiological loading capacity of the spine, and allow fast and painless mobilization. Unfortunately, this elderly, osteoporotic patient population poses serious challenges to spinal surgery, due to tissue frailty and frequent comorbidities. More specifically, all the surgical stabilization techniques include rigid posterior fixation of multiple spinal segments, but the reduced bone mechanical properties of osteoporotic patients can lead to hardware implant failure, new fractures, complications, and need of re-intervention.
On the other hand, treatment and reinforcement of the anterior spinal column, that should enhance posterior stabilization, requires a more invasive surgical approach, which carries a significant rate of complications and prolonged recovery times in this elderly population.
A recently described minimally-invasive interventional technique, called Stent-screw Assisted Internal Fixation (SAIF), can reconstruct, stabilize and restore axial load capability of the vertebral body affected by severe fractures, potentially obviating the need of a surgical multi-level rigid construct.
The study seeks primarily to determine whether the SAIF intervention is not inferior to surgical stabilization in improving quality of life in subjects with unstable OVFs at one year follow-up.
The principle secondary objective of this study is to evaluate whether the effect of the SAIF intervention on the radiological outcome is not inferior to surgical stabilization in subjects with OVFs.
Other secondary objectives are to compare both treatments in terms of safety, length of operation, blood loss, days of hospitalization postoperatively, pain, the intake of analgesics, disability and cost-effectiveness.
The total expected number of patients to randomized is 140, 70 per group. This ensures 80% power to test the hypothesis that SAIF is not inferior to surgical stabilization in increasing quality of life measured with the QUALEFFO questionnaire, assuming a standard deviation of 16 points, with a non-inferiority margin of 8 points. This also ensures over 90% power to exclude a non-inferiority margin of 4 degrees of kyphosis correction. The alpha for testing is set at 5%.
Estimated duration for the main investigational plan will be 60 months (from start of screening of first subject to last subject processed and finishing the study).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent-screw Assisted Internal Fixation (SAIF) | Experimental | Procedure: Stent-screw Assisted Internal Fixation (SAIF)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. |
| Surgical stabilization | Active comparator | Procedure: Surgical stabilizationSpinal 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent-screw Assisted Internal Fixation (SAIF)Also: SAIFImplanting vertebral body stents (VBS), followed by insertion of percutaneous, fenestrated, cement-augmented pedicular screws | Procedure or surgery | Stent-screw Assisted Internal Fixation (SAIF) |
| Surgical stabilizationSpinal fixation with cement augmented pedicle screws bridging the fractured vertebra | Procedure or surgery | Surgical stabilization |
Primary outcome
Change in the Quality of Life questionnaire of the European Foundation of Osteoporosis (QUALEFFO) score.
Time frame: at 12 months from baseline.
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.
11 secondary outcomes
restoration of angular kyphosis at index level
Time frame: pre-operative and at 1, 6 and 12 months follow up
vertebral body height restoration
Time frame: Baseline and 1 day after the intervention
global kyphosis/lordosis
Time frame: pre-operative and at 1, 6 and 12 months follow up
Global Sagittal Balance
Time frame: pre-operative and at 1, 6 and 12 months follow up
length of operation
Time frame: Perioperative
blood loss
Time frame: up to 1 week
days of hospitalization postoperatively
Time frame: up to a week
back pain
Time frame: at baseline and at 1, 3, 6 and 12 months follow up
the intake of analgesics using the Medication Quantification Scale (MQS).
Time frame: at baseline and at 1, 3, 6 and 12 months follow up
disability using Roland-Morris disability questionnaire (RMDQ)
Time frame: at 1, 3, 6 and 12 months follow up
cost-effectiveness
Time frame: up to 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Derived from this study: PubMed 42468948Cianfoni 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.
- Individual participant dataSharing planned: Yes. 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
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent-screw Assisted Internal Fixation (SAIF) and Surgical stabilization in people with Unstable Osteoporotic Vertebral Compression Fractures, run by Eva Koetsier MD PhD at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Koetsier, MD PhD LLM (0041(0)783388933, Eva.Koetsier@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Quality of Life questionnaire of the European Foundation of Osteoporosis (QUALEFFO) score. (time frame: at 12 months from baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07071870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.