NCT00211237已完成不适用
A Multicenter, Prospective, Randomized, Controlled Study to Compare Balloon Kyphoplasty to Non-surgical Fracture Management in the Treatment of Painful, Acute Vertebral Body Compression Fractures in Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 35
- 主要终点
- The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month
研究概览
简要总结
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients with cancer.
详细描述
- STUDY OBJECTIVES AND ENDPOINTS
1.1. Objectives
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, VCFs as compared to standard non-surgical therapy in patients with cancer.
1.2. Primary Endpoint
The primary endpoint of the study is the improvement in functional status, as measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 month. The primary hypothesis of the study is that the mean improvement will be larger in subjects initially assigned to management with balloon kyphoplasty. Note that all subjects will undergo 12 months of follow-up after initial treatment assignment.
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
- •One to 3 painful (pain on palpation/percussion over fractured vertebral body) VCF(s), T5-L5, with either bone marrow edema imaged by magnetic resonance imaging (MRI) or a fracture imaged by plain radiographs using the method of Genant
- •Pain NRS score ≥4 on a scale of 0 to 10
- •When the patient is newly diagnosed with multiple myeloma, the pain assessment must not be done until after completion of at least one pulse of steroid therapy or one week after the initiation of active multiple myeloma therapy.
- •Roland Morris Disability Questionnaire score ≥ 10 on a scale of 0 to 24
- •Patients must be at least 21 years old.
- •No change in chemotherapy regimen (change in dose(s) permitted) for 1 month prior to enrollment
- •No change in chemotherapy regimen (change in dose(s) permitted) planned for at least 1 month following enrollment
- •No major surgery to the spine planned for at least 1 month following enrollment
- •Life expectancy of ≥ 3 months
- •Patient has sufficient mental capacity to comply with the protocol requirements
- •Patient has stated availability for all study visits
- •Patient is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent.
排除标准
- •Patients with primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma at site of the index VCF. Patients with these tumors in anatomic sites other than the index VCF are eligible.
- •Concurrent Phase I investigational anti-cancer treatment
- •Significant clinical morbidities (aside from the index fracture(s) and cancer) that may potentially interfere with the collection of data concerning pain and function
- •VCF morphology deemed unsuitable for balloon kyphoplasty
- •Additional non-kyphoplasty surgical treatment is required for the index fracture
- •Patients requiring the use of high-dose steroid (≥ 100 mg prednisone or 20 mg dexamethasone per day), intravenous (IV) pain medication, or nerve block to control chronic back pain unrelated to index VCF(s). Patients who receive high-dose steroids for treatment of their cancer (for at least 30 days) are eligible.
- •Patients with a platelet count of < 20,000 measured at the time of hospital admission for the procedure
- •Spinal cord compression or canal compromise requiring decompression
- •Patients with osteoblastic tumors at the site of index VCF. Patients with osteoblastic tumors outside of vertebral levels intended for kyphoplasty may be enrolled.
- •Medical/surgical conditions contrary to the balloon kyphoplasty procedure (e.g., in the presence of active or incompletely treated local infection)
- •Known allergy to bone cement or contrast medium used in the treatment of study subjects
- •MRI contraindication (e.g., cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis)
- •Positive baseline pregnancy test (for women of child-bearing potential)
- •Patients who may require allogeneic bone marrow transplantation during the course of the study.
- •Other Reasons for Lack of Enrollment:
- •A. Patient is afraid to have surgery
- •B. Patient is afraid to have anesthesia
- •C. Patient/family is not willing to participate in research
- •D. Patient is not willing to be randomized
结局指标
主要结局
The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month
时间窗: Baseline and 1 Month
The full scale name is the Roland-Morris Disability Questionnaire; it is a validated measure of physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability)
次要结局
- Change in Roland-Morris Disability Questionnaire Score(Baseline, 1 month, 3 months, 6 months, and 12 months)
- Change in Back Pain(Baseline, 1 month, 3 months, 6 months, and 12 months)
- Change in Functional Status Assessed With the Karnofsky Performance Scale(Baseline, 1 month, 3 months, 6 months, and 12 months)
- Change in Quality of Life.(Baseline and 1 month)
- Change in Quality of Life(Baseline, 1 month, 3 months, 6 months, and 12 months)
- Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks(Baseline, 1 month, 3 months, 6 months, and 12 months)
- Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks(Baseline, 1 month, 3 months, 6 months, and 12 months)
- Ambulatory Status Change From Baseline to One Month(1 month)
- Ambulatory Status Change(Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months)
- Change in Neurology Status From Baseline (Motor Strength)-Per Protocol(1 month, 3 months, 6 months, and 12 months)
- Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks(Baseline, 1 month, 3 months, 6 months, and 12 months)
- Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month(Baseline and 1 month)
- Back Pain Analgesics Used(Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months)
- Index Spinal Deformity Change Measured by Index Vertebral Body Angles(Baseline, post-operation, 1 month, and 12 months)
- Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio(Baseline, post-operation, 1 month, and 12 months)
- Change in Neurology Status From Baseline (Motor Strength)(1 month)
- Change in Neurological Status From Baseline (Reflex Strength)(1 months, 3 months, 6 months, and 12 months)
- Change in Neurological Status From Baseline (Sensory Examination)(1 months, 3 months, 6 months, and 12 months)
- Change in Neurological Status From Baseline (Limb Strength)(1 months, 3 months, 6 months, and 12 months)
- Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline(1 month)
- Rate of Study Treatment-related Adverse Events Till Study Completion(12 months)
- Rate of Subsequent Vertebral Body Fractures(1 month and 12 months)
研究者
研究点 (35)
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