A Pilot Study of Vertebral Augmentation With Kyphoplasty Versus Nonsurgical Management in Multiple Myeloma Patients With Mildly Symptomatic Vertebral Body Compression Fractures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Time to Vertebral Event
研究概览
简要总结
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.
详细描述
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 multiple myeloma patients. Because of the pilot nature and the small sample size of the study, patient randomization will NOT be stratified. Patients with mildly symptomatic vertebral compression fractures (VCFs) will undergo a 1:1 randomization either balloon kyphoplasty or non surgical management. Randomization assignments will be generated by computer and investigator notified once the patient enrolled.
The observational arm will be compared to each of the other two arms; control and intervention arm using the same outcome variables and statistical methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Time to Vertebral Event
时间窗: Average of 12 months
Time to vertebral event (composite end point of pain progression, hospitalization for pain, and rescue vertebral augmentation or surgery or radiation therapy as related to an index fracture)
Time to Pain Progression
时间窗: Average of 12 months
Time to pain progression defined as the time to the development of pain severity rated greater than 4 on the visual analog scale (VAS) as related to an index fracture
次要结局
- Rate of Vertebral Events(12 months)
- Rate of Hospitalization(12 months)
- Complications of Procedure(Average of 12 months)
- Quality of Life Questionnaire Results(Average of 12 months)
- Changes in Pulmonary Function(Average of 12 months)
- Change in Kyphosis(Average of 12 months)
- Prognostic Ability of Bone Biomarkers(Average of 12 months)