Clinical Trials Logo
  1. Home
  2. Spinal Fractures
  3. NCT00594321

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Status Withdrawn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
See also
  Status Clinical Trial Phase
Terminated NCT02931266 - PASS MIS® Post-market Clinical Follow-up
Completed NCT02566655 - Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis Phase 1
Unknown status NCT00290862 - A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by Osteoporosis N/A
Completed NCT04956588 - Evaluation of the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery Phase 3
Completed NCT04201678 - Effectiveness of Erector Spinae Block in Kyphoplasty N/A
Completed NCT02931279 - PASS OCT® Post-market Clinical Follow-up
Completed NCT02950532 - Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures
Completed NCT02839057 - Survival After Surgical Treatment of Axis Fractures in Elderly N/A
Completed NCT02719340 - Short Segment Fixation in Thoracolumbar Osteoporotic Fracture N/A
Completed NCT02826889 - Assessing the Diagnostic Accuracy of Corrected Flow Time (FTc) and Pleth Variability Index (PVI) as Predictors of Fluid Responsiveness in Patients in the Prone Position Using the Jackson Table N/A
Recruiting NCT02768675 - Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery N/A
Completed NCT00211237 - CAFE Study - Cancer Patient Fracture Evaluation N/A
Recruiting NCT02784782 - Thoracolumbar Burstfractures, Orthesis or No Orthesis Phase 4
Withdrawn NCT04325165 - DBS of PPN to Improve Walking in Chronic SCI Patients N/A
Completed NCT01123512 - The Kiva® System as a Vertebral Augmentation Treatment Phase 3
Not yet recruiting NCT02603874 - The Development of a Vertebra Localizing Aid Medical Device N/A
Completed NCT01761084 - Build Better Bones With Exercise N/A
Completed NCT02840695 - Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS) N/A
Completed NCT02657265 - SpineJack® Versus Conservative Treatment Study (SPICO Study) N/A
Active, not recruiting NCT02789774 - Uppsala Study on Odontoid Fracture Treatment in the Elderly N/A