Patients at the age of 50 or older presenting with thoracolumbar fractures including segments TH 6-L5 and A3/A4 fractures according to the AO Spine fracture classification after the acute trauma and planned surgery within 3 weeks following trauma will be asked to participate in a randomized trial in which they will receive either Calciumphosphate (CaP) or Polymethylmethacrylate (PMMA) as part of a standardized treatment approach. Regardless of the group patients are randomized to, all participating patients undergo the same surgical procedure except for the preparation and administration of bone cement. The study participation period for each patient is 1 year from the date of the surgery and includes 4 defined time points that include follow-up clinical visits for imaging and progress checks at 6 weeks, 3 months, 6 months and 12 months after surgery. At each follow-up visit, a combination of questionnaires and radiological imaging will be performed to assess general health status, disability level and pain control, as well as objective results of the surgery. The main outcome measure will be the loss of correction rate that will be measured through the bi-segmental COBB angle presented in the CT-scan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
85
Dorsal instrumentation via Longitude II (Medtronic Austria GmbH/Vienna) and balloon kyphoplasty are performed. KyphOs FS™ bone cement will be introduced in the fractured vertebral body.
Dorsal instrumentation via Longitude II (Medtronic Austria GmbH/Vienna) and balloon kyphoplasty are performed. KYPHON ActivOs® Bone Cement with Hydroxyapatite will be introduced in the fractured vertebral body.
The change in correction rates when using CaP
The main outcome measure 1 will be the loss of correction rate that will be measured through the bi-segmental COBB angle presented in the CT-scan. The Cobb angle will be measured between the superior end plate of the vertebral body cephalad to the injury and the inferior end plate of the vertebral body caudal to the injury.
Time frame: Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively
The change in correction rates when using PMMA
The main outcome 2 measure will be the loss of correction rate that will be measured through the bi-segmental COBB angle presented in the CT-scan. The Cobb angle will be measured between the superior end plate of the vertebral body cephalad to the injury and the inferior end plate of the vertebral body caudal to the injury. Measurements will be taken from CT scans.
Time frame: Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively
The change in vertebral body height when using CaP
The percentage loss of the vertebral body height will be calculated by dividing the height of the fractured vertebra by the average height of the cephalad and caudad vertebrae and then subtracting this number from 100%. Measurements will be taken from CT scans.
Time frame: Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively
The change in vertebral body height when using PMMA
The percentage loss of the vertebral body height will be calculated by dividing the height of the fractured vertebra by the average height of the cephalad and caudad vertebrae and then subtracting this number from 100%.
Time frame: Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively
Changes in complication rates when using PMMA
The occurence of the complication rates, in particular cement extravasation and temporary fall in blood pressure, will be compared between the two groups for each time point using the Student´s t-test for independent samples. In addition, a paired Student´s t-test will be performed within each group in order to evaluate the differences in means of the secondary endpoints measured at the defined timepoints.
Time frame: 6 weeks, 3 months, 6 months and 12 months postoperatively
Changes in complication rates when using CaP
The occurence of the complication rates, in particular cement extravasation and temporary fall in blood pressure, will be compared between the two groups for each time point using the Student´s t-test for independent samples. In addition, a paired Student´s t-test will be performed within each group in order to evaluate the differences in means of the secondary endpoints measured at the defined timepoints.
Time frame: 6 weeks, 3 months, 6 months and 12 months postoperatively
Change in the disability on the ODI rating scale in patients with PMMA
ODI is mainly used in spine trauma patients. A score of 0% to 20% indicates minimal disability; 21% to 40%, moderate disability; and 41% to 60% severe disability.
Time frame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
Change in the disability on the ODI rating scale in patients with CaP
ODI is mainly used in spine trauma patients. A score of 0% to 20% indicates minimal disability; 21% to 40%, moderate disability; and 41% to 60% severe disability.
Time frame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
Change in pain on the spine VAS in patients with PMMA
VAS - Spine Visual Analogue Scale is a measurement that measures pain intensity and it is completed by patients themselves.
Time frame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
Change in pain on the spine VAS in patients with CaP
VAS - Spine Visual Analogue Scale is a measurement that measures pain intensity and it is completed by patients themselves.
Time frame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
Change in quality of life in patients with PMMA measured by the 36-item Short Form Survey
The 36-Item Short Form Survey (SF-36) will be used to assess patient´s self-reported quality of life.
Time frame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
Change in quality of life in patients with CaP measured by the 36-item Short Form Survey
The 36-Item Short Form Survey (SF-36) will be used to assess patient´s self-reported quality of life.
Time frame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
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