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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: DFINE Inc.

Current Primary Outcome: Improvement in functional status, as measured by the Oswestry Disability Index (ODI) [ Time Frame: 1 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Quality of Life (SF-35 Health Survey) [ Time Frame: 1 month, 3 month ]
  • Change in Back Pain (VAS) [ Time Frame: 1 month, 3 month ]
    Visual Analog Scale for pain
  • Change in Physical Disability associated with back pain (Roland-Morris Disability Questionnaire) [ Time Frame: 1 month, 3 month ]


Original Secondary Outcome: Same as current

Information By: Merit Medical Systems, Inc.

Dates:
Date Received: August 4, 2011
Date Started: May 2011
Date Completion:
Last Updated: January 18, 2017
Last Verified: January 2017