A Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 354
- 试验地点
- 50
- 主要终点
- SF-36v2 Physical Component Summary Change From Baseline at 3 Months
研究概览
简要总结
The study objective is to collect and report 12-month outcomes pertaining to activities of daily living, quality of life, and safety parameters in a Medicare population to be treated with balloon kyphoplasty in the treatment of painful, acute, vertebral body compression fractures (VCFs) associated with either osteoporosis or cancer. The primary objective is to show statistically significant improvement from baseline in the four co-primary endpoints (SF-36v2, PCS, EQ-5D, NRS back pain and ODI) at 3-months; study success will be declared if the primary objective is met. New radiographic fractures, non-surgical management received, VCF-related healthcare resource utilization, and vertebral body height restoration data will also be collected.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Identified as an appropriate candidate for BKP and should have made the choice to have the procedure.
- •Must be Medicare Eligible (At least 65 years of age or otherwise eligible).
- •Must have one to three target VCFs, located between T5 and L5, which are due to underlying primary or secondary osteoporosis or cancer.
- •Cancer patients should not have had a change in chemotherapy regimen within the last month, nor should they have a planned change within the next month from time of enrollment, with the exception of changes in dose.
- •All VCFs to be treated must have clinical pain symptoms (pain on palpation/percussion over the fractured vertebral body) that correlate with radiographic findings as follows:
- •Height change: An acute (≤ four month) change in VB height or morphology from a previous x-ray, CT or MRI, with height loss at the anterior, middle or posterior portion of the VB consistent with a worsening of one or more grades by the Genant criteria20, OR
- •Positive MRI or bone scan: VB shows hyperintense signal on STIR sequence MRI, or target VB is positive on radionuclide bone scan.
- •All VCFs to be treated must have an estimated fracture age of four months or less.
- •Treatment of all target VCFs must be technically feasible and clinically appropriate for balloon kyphoplasty.
- •Pre-treatment back pain by numerical rating scale (NRS) score must be ≥ 7 (0-10 scale) and refractory to non-surgical management.
- •Pre-treatment Oswestry Disability Index must be ≥30 (0 - 100 scale).
- •Must have life expectancy of ≥ 12 months.
- •Must declare availability for all study visits.
- •Must be able to understand the risks and benefits of participating in the study and be willing to provide written informed consent.
- •Must have the mental capacity necessary to comply with protocol requirements for the 12- month duration of study.
排除标准
- •Vertebral body morphology or fracture configuration contraindicative of balloon kyphoplasty.
- •VCFs due to high-energy trauma.
- •Asymptomatic VCFs or prophylactic treatment of non-fractured vertebral bodies.
- •VCFs accompanied at the same site by primary tumors of the bone (e.g., osteosarcoma), solitary plasmacytoma or osteoblastic tumors.
- •Platelet count of <20,000/uL as measured at the time of hospital admission for the procedure.
- •Back pain due to causes other than acute fracture.
- •VCF with a clinically estimated (based on radiographic evidence as well as patient history) age of fracture > four months.
- •VCF accompanied by objective evidence of secondary radiculopathy or neurologic compromise.
- •VCFs with the need for spinal surgery beyond balloon kyphoplasty.
- •Spinal cord compression or canal compromise requiring decompression.
- •Significant clinical comorbidity that may either contra-indicate surgery or interfere with long-term data collection or follow-up.
- •Pre-existing conditions contrary to balloon kyphoplasty such as:
- •Allergy to any components (e.g., bone cement, contrast medium) of the balloon kyphoplasty device/procedure.
- •Active or incompletely treated infection of the vertebral column or active systemic infection, including unresolved urinary tract infection.
- •Irreversible coagulopathy or bleeding disorder.
- •Contraindications to both MRI and radionuclide bone scan.
- •Concurrent participation in another clinical study.
- •Pregnant or intending to become pregnant during the course of the study.
结局指标
主要结局
SF-36v2 Physical Component Summary Change From Baseline at 3 Months
时间窗: Baseline, 3 months after surgery
Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.
Change From Baseline in Quality of Life by the EQ-5D Index at 3 Months
时间窗: Baseline, 3 months after surgery
EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.
Back Pain Change From Baseline at 3 Months
时间窗: Baseline, 3 months after surgery
Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."
Back Function Change From Baseline by Oswestry Disability Index at 3 Months
时间窗: Baseline, 3 months after surgery
ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
次要结局
- Barthel Index (Only for Subjects With Osteoporosis)(Baseline, 30 days, 3 months 6 months, and 12 months)
- Quality of Life by EQ-5D Index Score(Baseline, 30 days, 6 months, and 12 months)
- Quality of Life by SF-36v2 PCS(Baseline, 30 days, 6 months, and 12 months)
- The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks;(Baseline, 30 days, 3 months, 6 months, and 12 months)
- Vertebral Body Angle(Baseline, pre-discharge, 3 months, and 12 months)
- Back Pain(Baseline, 7 days, 30 days, 6 months, 9 months, and 12 months)
- Back Function (ODI)(Baseline, 30 days, 6 months, and 12 months)
- Subsequent Radiographic Fractures(3 months and 12 months)
- Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks(Baseline, 30 days, 3 months, 6 months, and 12 months)
- Ambulatory Status(Baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 months)
- Local Cobb Angle(Baseline, pre-discharge, 3 months, and 12 months)
- Karnofsky Performance Scale(Baseline, 30 days, 3 months 6 months, and 12 months)
- Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP)(Baseline, pre-discharge, 3 months, and 12 months)
- Neurological Success Rate(Pre-discharge, 30 days, 3 months, 6 months, and 12 months)