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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 85
- Primary Endpoint
- The change in correction rates when using CaP
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Patients and study nurse will be blinded to treatment allocation; however, surgeons cannot be blinded due to different techniques of bone cement application. A centralized and automated internet-based randomization system will ensure concealed randomization of study participants. Participants will be the unit of randomization. Randomization will be carried out with randomizer.at and will occur prior to the surgical procedure.
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The change in correction rates when using CaP
Time Frame: Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively
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.
The change in correction rates when using PMMA
Time Frame: Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively
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.
Secondary Outcomes
- Change in quality of life in patients with PMMA measured by the 36-item Short Form Survey(Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively))
- Changes in complication rates when using PMMA(6 weeks, 3 months, 6 months and 12 months postoperatively)
- Change in the disability on the ODI rating scale in patients with PMMA(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(Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively))
- Changes in complication rates when using CaP(6 weeks, 3 months, 6 months and 12 months postoperatively)
- Change in pain on the spine VAS in patients with PMMA(Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively))
- The change in vertebral body height when using CaP(Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively)
- The change in vertebral body height when using PMMA(Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively)
- Change in the disability on the ODI rating scale in patients with CaP(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(Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively))