The objective of the clinical trial is to evaluate the SPACE 360 Delivery System using SPACE CpsXL Bone Cement compared to standard vertebroplasty in the treatment of pathological fractures of the spine caused by metastatic tumors of the spine, myeloma, or lymphoma. Up to a total of three levels per patient may be included or five levels for multiple myeloma. The control group will be standard vertebroplasty.
The primary endpoint is cement leakage as determined radiographically (CT). will be cement leakage measured by CT. Secondary endpoints are reduction of pain (VAS) and quality of life measurements (Oswestry disability index).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
SPACE CpsXL Bone Cement and SPACE 360 Delivery System
standard vertebroplasty
UC Davis Medical Center
Sacramento, California, United States
The primary endpoint is cement leakage as determined radiographically (CT). will be cement leakage measured by CT.
Time frame: 3 years
Secondary endpoints are reduction of pain (VAS) and quality of life measurements (Oswestry disability index).
Time frame: 3 years
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