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

NCT00594321 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-09-03

No results posted yet for this study

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.

Conditions

  • Spinal Fractures

Interventions

DEVICE

SPACE CpsXL Bone Cement and SPACE 360 Delivery System

SPACE CpsXL Bone Cement and SPACE 360 Delivery System

DEVICE

standard vertebroplasty

standard vertebroplasty

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Arthur B. Dublin, M.D. · UC Davis Dept. of Radiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00594321 on ClinicalTrials.gov