Calcium Phosphate Versus PMMA Cement in Thoracolumbar Fractures

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

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.

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