NCT01410929

Evaluation of Vertebral Compression Fracture Fixation With RF Kyphoplasty in Patients With Multiple Myeloma

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: DFINE Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The objective of this post market clinical study is to collect prospective clinical data to confirm the efficacy of RF Kyphoplasty for the treatment of pathological fractures of the spine caused by multiple myeloma.

Detailed description

Myeloma is the commonest primary cancer affecting the spine. Painful vertebral compression fractures (VCFs) affect approximately 30% of myeloma patients. As myeloma patients live longer, it is especially relevant to provide the best available treatment for pain and reduce disabilities that can result from VCFs. Cement delivery is a well established treatment method for treating painful vertebrae compromised by tumor and/or osteoporosis. The StabiliT Vertebral Augmentation System (DFine Inc.) is a unique percutaneous vertebral augmentation system designed to provide the physician a means of creating targeted cavities and an ultra-high viscosity cement (using RF Energy) that can be delivered over an extended period of time in order to allow for controlled, targeted vertebral augmentation in multiple myeloma patients.

Conditions

• Multiple Myeloma
• Compression Fracture of Vertebral Column

Interventions

Type	Name	Description
PROCEDURE	Kyphoplasty/Vertebral Augmentation (Device-StabiliT)	Targeted Vertebral Augmentation for the treatment of pathological fractures of the spine caused by multiple myeloma

Timeline

• Start date: 2011-05-01
• First posted: 2011-08-05
• Last updated: 2017-01-20