NCT01410929撤回4 期
Evaluation of Vertebral Compression Fracture Fixation With RF Kyphoplasty in Patients With Multiple Myeloma
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- DFINE Inc.
- 主要终点
- Improvement in functional status, as measured by the Oswestry Disability Index (ODI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosis of multiple myeloma and evidence of myelomatous lesions in the spine, including plasmacytomas, lytic lesions and fractures.
- •One to 6 painful (pain on palpation/percussion over fractured vertebral body) VCF(s), T3-L5, with bone marrow edema imaged by magnetic resonance imaging (MRI) (Subjects with 4-6 fractures treatment will be divided into two sessions 1- 7 days apart)
- •History of fracture related pain less than ≤ 3 months old
- •Pain VAS score ≥4 on a scale of 0 to
- •When the subject 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 chemotherapy. Pain represents worst pain without use of narcotic medications.
- •Roland Morris Disability Questionnaire score ≥ 10 on 0 to 24 scale
- •Subjects is ≥ 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
- •Subject has no major surgery to the spine planned for at least 1 month following enrollment
- •Subject has sufficient mental capacity to comply with the protocol requirements
- •Subject must be willing and able to comply with specified follow-up evaluations
- •Subject understands the potential risks and benefits of participating in the study and is willing to provide written informed consent.
- •Female subjects must either be no longer capable of reproduction or taking acceptable measures to prevent pregnancy during the study
排除标准
- •Subjects with primary tumors of the bone (e.g., osteosarcoma) or osteoblastic metastases at site of the index VCF. Subjects with these tumors in anatomic sites other than the index VCF are eligible.
- •Subject is concurrent Phase I investigational anti-cancer treatment
- •Subject has significant clinical morbidities (aside from the index fracture(s) and cancer) that may potentially interfere with the collection of data concerning pain and function
- •Subject has VCF morphology deemed unsuitable for RF Kyphoplasty (e.g. vertebral planna)
- •Additional non-kyphoplasty surgical treatment is required for the index fracture
- •Subjects 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). Subjects who receive high-dose steroids for treatment of their cancer (for at least 30 days) are eligible.
- •Subjects with a platelet count of < 20,000
- •Subject has spinal cord compression or significant canal compromise requiring decompression
- •Subjects with VCFs due to osteoporosis
- •Subject has medical/surgical conditions contrary to the kyphoplasty procedure (e.g., in the presence of active or incompletely treated local infection)
- •Positive baseline pregnancy test (for women of child-bearing potential)
- •Subject has neurologic deficit associated with the level(s) to be treated more severe than radiculopathy (e.g. myelopathy, cauda equina syndrome)
- •Subject has segmental kyphosis > 30° in area of treatment
- •Subject has uncontrolled coagulopathy
- •Subject cannot temporarily discontinue anticoagulation therapy
- •Subject has a known allergy to device materials / PMMA
- •Index VCF was exposed to high energy trauma
- •Subject has severe cardiopulmonary deficiencies as contra-indication to local or general anesthesia required for the procedure.
结局指标
主要结局
Improvement in functional status, as measured by the Oswestry Disability Index (ODI)
时间窗: 1 month
次要结局
- Change in Physical Disability associated with back pain (Roland-Morris Disability Questionnaire)(1 month, 3 month)
- Change in Quality of Life (SF-35 Health Survey)(1 month, 3 month)
- Change in Back Pain (VAS)(1 month, 3 month)
研究者
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