NCT00594321

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Spinal Fractures

Interventions

Type	Name	Description
DEVICE	SPACE CpsXL Bone Cement and SPACE 360 Delivery System	SPACE CpsXL Bone Cement and SPACE 360 Delivery System
DEVICE	standard vertebroplasty	standard vertebroplasty

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-01-15
• Last updated: 2012-09-03

Locations

1 site across 1 country: United States