Calcium Phosphate Versus PMMA Cement in Thoracolumbar Fractures

SPINAL Fracture Clinical Trial

— CaPvsPMMA  

Official title:

Calcium Phosphate Versus PMMA Cement in Unstable Thoracolumbar Burst Fractures Treated With Dorsal Instrumentation in Patients > 50 Years of Age Randomized Controlled Non-inferiority Trial Design

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04743869
• Other study ID #: V 2.0
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fractures, Bone
• SPINAL Fracture
• Spinal Fractures

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)