Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures (NCT01175278) | Clinical Trial Compass
WithdrawnNot Applicable
Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures
Stopped: No enrollment
0Started 2010-07
Plain-language 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 compression fractures while providing pain relief and improved function and quality of life.
Who can participate
Age range21 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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).…
What they're measuring
1
Time to Vertebral Event
Timeframe: Average of 12 months
2
Time to Pain Progression
Timeframe: Average of 12 months
Trial details
NCT IDNCT01175278
SponsorH. Lee Moffitt Cancer Center and Research Institute