Status:
WITHDRAWN
Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Medtronics, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of this study is to find out how balloon kyphoplasty (surgical repair of the patient's fracture using balloons and bone cement) compares to non-surgical treatment in reducing vertebral com...
Detailed Description
This is a prospective single center study designed to compare balloon kyphoplasty to non-surgical management (NSM) in the treatment of mildly painful, acute vertebral body compression fractures in mul...
Eligibility Criteria
Inclusion
- Patients with multiple myeloma (active or smoldering) with mild back pain (Visual Analog Scale \[VAS\]) ≤ 4 or no back pain (VAS=0) on a stable analgesic regimen) related to vertebral compression fractures (at least one and up to 8 index fractures from T3 to L5) as seen on magnetic resonancy imaging (MRI), computed axial tomography (CT) scan or plain radiographs.
- No major planned spine surgery for at least 6 months following enrollment.
- No evidence of epidural disease or cord compromise on magnetic resonance imaging.
- Life expectancy greater than 6 months.
- Adequate myeloma systemic control (no evidence of active progressive disease). No planned change in chemotherapy regimen for 1 month prior and for at least 1 month following enrollment. Change in dose(s) permitted.
- Adequate hematologic parameters (platelet count≥50,000/μL, and absolute neutrophil count ≥1,000). Platelet transfusions are permitted to increase platelet counts perioperatively.
- Age greater than 21 years and able to understand and sign the informed consent document.
Exclusion
- Patients with significant comorbidities (aside from the index fracture or cancer) which would result in an unacceptable surgical risk or patients with contraindications to general or local anesthesia.
- Patients with other primary tumors including primary bone tumors or solitary plasmacytoma at site of the index VCF.
- VCF morphology deemed unsuitable for balloon kyphoplasty (vertebra planum).
- Additional non-kyphoplasty surgical treatment is required for the index fracture.
- Patients with uncontrolled pain related to the VCF (VAS\>4, or increasing opioid requirements), or with epidural disease on magnetic resonance imaging. Spinal cord compression , canal compromise and /or spinal instability requiring decompression.
- Patients with a bleeding disorder which cannot be adequately managed perioperatively.
- Patients with pain unrelated to the VCF according to the investigators.
- Patients with estimated survival less than 6 months.
- Known allergy to bone cement or all contrast media used in the treatment of study participants.
- MRI contraindication (e.g., cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis).
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01175278
Start Date
July 1 2010
End Date
May 1 2011
Last Update
January 12 2012
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