NCT04743869

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• SPINAL Fracture

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2021-02-01
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2021-02-08
• Last updated: 2021-02-08