Spots Global Cancer Trial Database for Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine

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Trial Identification

Brief Title: Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine

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

Study ID: NCT00594321

Conditions

Spinal Fractures

Interventions

SPACE CpsXL Bone Cement and SPACE 360 Delivery System

standard vertebroplasty

Study Description

Brief 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.

Detailed 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).