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Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine — EFFECTS  

Spinal Fractures Clinical Trial

Official title:
Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00594321
Study type Interventional
Source University of California, Davis
Contact
Status Withdrawn
Phase N/A
Start date July 2007
Completion date June 2009
View Details
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