Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups
研究概览
简要总结
Balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression fractures has been shown to be successful in providing acute pain relief, enabling improved function, and restoring of vertebral body height. However, limited prospective data exists in the investigation of unipedicular balloon kyphoplasty as a sufficient alternative to bipedicular balloon kyphoplasty. The purpose of this prospective randomized study was to compare the clinical and radiographic outcomes of unipedicular and bipedicular balloon kyphoplasty.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females older than 50 years of age with acute vertebral compression fractures causing significant pain and functional limitations in their daily activities.
排除标准
- •primary tumors of bone or evidence of metastasis at the index vertebrae
- •pre-existing chronic pain or functional disability unrelated to a vertebral compression fracture which would confound the data analysis
- •fracture secondary to a traumatic event
- •inability to fully visualize both pedicles of the fractured vertebrae on intraoperative fluoroscopy
结局指标
主要结局
Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups
时间窗: Preoperative questionnaire within 3 weeks before surgery and postoperative questionnaires at 3 months after surgery
The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Change in RDQ in the Bipedicular Group From 3 to 12 Months
时间窗: 3-12 months post operation
The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. A score of 0 indicates no low back pain, while a score of 24 indicates significant low back pain.
次要结局
- Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups(3 months post-op)
- Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups(3 months post-op)
- Comparison of 12 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups(12 months post-op)
- Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty(Preoperative assessment within 3 weeks before surgery and postoperative day 1)
- Measurement of Change in Kyphotic (Cobb) Angle Following Kyphoplasty(Preoperative assessment within 3 weeks before surgery and postoperative day 1)
- Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups(12 months post-op)
- Middle Vertebral Body Height Restoration Following Surgery With Kyphoplasty(Preoperative assessment within 3 weeks before surgery and postoperative day 1)
- Comparison of 12 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups(12 months post-op)