Calcium Phosphate Versus PMMA Cement in Thoracolumbar Fractures (CaPvsPMMA)
SPINAL Fracture
About this trial
This is an interventional treatment trial for SPINAL Fracture focused on measuring Spinal Fractures, Fractures, Polymethyl Methacrylate, PMMA, Bone Cements, Calciumphosphate, Thoracolumbar Fractures, Dorsal Instrumentation, Burst Fractures, Balloon Kyphoplasty
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
KYPHON® ActivOs™10 Bone Cement with hydroxyapatite
KyphOs FS™
As a reference device KYPHON® ActivOs™10 Bone Cement with hydroxyapatite (Medtronic) for treatment of vertebral compression fractures will be used. It is a polymethylmethacrylate (PMMA) bone cement containing hydroxyapatite (HA) for use in the treatment of patients with vertebral compression fractures (VCFs) who are undergoing minimally invasive surgery with KYPHON® Balloon Kyphoplasty. This bone substitute has already been approved and is in use in the patients at the age of 50 or older.
The test device KyphOs FS™ will be used in patients at the age of 50 and older in order to prove its superiority over the currently used PMMA bone cement.