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| Name | Class |
|---|---|
| Prof. Dr. Med. Alessandro Cianfoni, MD PhD, Neurocenter of Southern Switzerland - Ente Ospedaliero Cantonale (EOC) | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent-screw Assisted Internal Fixation (SAIF) | Procedure | Implanting vertebral body stents (VBS), followed by insertion of percutaneous, fenestrated, cement-augmented pedicular screws |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcomes | adverse events and serious adverse events | up to 12 months. |
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Koetsier, MD PhD LLM | Contact | 0041(0)783388933 | Eva.Koetsier@eoc.ch | |
| Alessandro Cianfoni, MD PhD | Contact | 0041 (0)918116027 | Alessandro.Cianfoni@eoc.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EOC Lugano | Lugano | Canton Ticino | 6900 | Switzerland |
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
Beginning 6 months following publication and available for up to 5 years.
Researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding author. Data will be shared after approval and signing of a data access agreement.
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| Surgical stabilization | Procedure | Spinal fixation with cement augmented pedicle screws bridging the fractured vertebra |
|
| 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. | 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 | 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 | pre-operative and at 1, 6 and 12 months follow up |
| length of operation | minutes from skin insertion to skin closure during the tratment | Perioperative |
| blood loss | blood transfusion from the beginning of the intervention to discharge | 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 | 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. | 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 | 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. | 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. | up to 12 months. |