Clinical trial NCT04743869: Calcium Phosphate Versus PMMA Cement in Thoracolumbar Fractures
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SPINAL Fracture
Keywords: Spinal Fractures
Fractures
Polymethyl Methacrylate
PMMA
Bone Cements
Calciumphosphate
Thoracolumbar Fractures
Dorsal Instrumentation
Burst Fractures
Balloon Kyphoplasty
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 85
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The change in correction rates when using CaP
timeFrame: Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively
measure: The change in correction rates when using PMMA
timeFrame: Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively
Secondary outcomes:
measure: The change in vertebral body height when using CaP
timeFrame: Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively
measure: The change in vertebral body height when using PMMA
timeFrame: Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively
measure: Changes in complication rates when using PMMA
timeFrame: 6 weeks, 3 months, 6 months and 12 months postoperatively
measure: Changes in complication rates when using CaP
timeFrame: 6 weeks, 3 months, 6 months and 12 months postoperatively
measure: Change in the disability on the ODI rating scale in patients with PMMA
timeFrame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
measure: Change in the disability on the ODI rating scale in patients with CaP
timeFrame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
measure: Change in pain on the spine VAS in patients with PMMA
timeFrame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
measure: Change in pain on the spine VAS in patients with CaP
timeFrame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
measure: Change in quality of life in patients with PMMA measured by the 36-item Short Form Survey
timeFrame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
measure: Change in quality of life in patients with CaP measured by the 36-item Short Form Survey
timeFrame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Graz
name: Paul Puchwein, Assist.Prof.
role: PRINCIPAL_INVESTIGATOR
References: