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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04743869
Other study ID # V 2.0
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2021
Est. completion date February 2024

Study information

Verified date February 2021
Source Medical University of Graz
Contact Gloria Hohenberger, Assist.Prof.
Phone +43 316 385 81721
Email gloria.hohenberger@medunigraz.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 85
Est. completion date February 2024
Est. primary completion date February 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Written consent of the participant after being informed - Acute trauma (surgery within three weeks following trauma) - Thoracolumbar fractures including segments TH 6-L5 - A3/A4 fractures according to the AO Spine fracture classification - Patient age = 50 years - Minimum follow up 1 year Exclusion Criteria: - Presence of neurological deficits at the time of surgery - Pathological fractures (bone metastases) - Traumatic brain injury - Ankylosing spondylitis as a comorbidity - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Kyphos FS™ Bone Substitute
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.
KYPHON ActivOs® Bone Cement with Hydroxyapatite
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Graz

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively
Primary 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. Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively
Secondary 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. Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively
Secondary 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%. Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively
Secondary 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. 6 weeks, 3 months, 6 months and 12 months postoperatively
Secondary 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. 6 weeks, 3 months, 6 months and 12 months postoperatively
Secondary 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. Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
Secondary 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. Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
Secondary 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. Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
Secondary 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. Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
Secondary 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. Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
Secondary 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. Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
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