A Modified Placement of Two Additional Pedicle Screws at the Fracture Level for the Treatment of Thoracolumbar Burst Fractures--a Study Protocol of a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- compression ratio change of anterior border of vertebral body height
研究概览
简要总结
Controversies exist about the best treatment of burst fractures of the thoracolumbar spine. Adding screws in fractured segment has been proved in many literatures that can improve construct stiffness but sometimes aggravate the trauma of fractured vertebra. Therefore, we are eager to find an optimized placement of two additional pedicle screws at the fracture level for the treatment of thoracolumbar burst fractures. This is the first randomised controlled study investigating efficacy of diverse orders of pedicle screws placement and will provide recommendations for treating patients with thoracolumbar burst fractures.
详细描述
A blinded randomised controlled trial (blinding for the patient and statistician, rather than for the clinician and researcher) will be conducted. A total of seventy patients with single thoracolumbar AO type A3 or A4 fractures who are candidates for application of short-segment pedicle screws of fractured vertebrae will be randomly allocated to either the DS group (distraction-screws ) or the SD group (screws-distraction) at a ratio of 1: 1. The primary clinical outcome measures are compression ratio of anterior border of vertebral body height, depth of nail into injured vertebrae and kyphosis (Cobb) angle. Secondary clinical outcome measures are complications, Visual Analogue Scale (VAS) of back and leg pain, neurological function, operating time, intraoperative blood loss, Japanese Orthopaedic Association (JOA) scores and Oswestry Disability Index. These parameters will be evaluated preoperatively, intraoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or above.
- •single thoracolumbar burst fractures
- •AO type A3 or A4 fractures
- •Thoracolumbar Injury Classification and Severity Score (TLICS) of more than 4 and duration of < 2 weeks
- •application of posterior short-segment pedicle screws instrumentation at the fracture level
排除标准
- •previous pedicle instrumentation at the same level
- •multi-segmental thoracolumbar fractures or not AO type A3 or A4 are found
- •active infection or surgical site of the previous infection
- •planned emigration abroad within 2 years after inclusion
- •suffering from illness or long-term use of certain drugs affecting the stability of the spinal environment, such as metabolic bone disease, spinal tuberculosis and so on
- •the current use of anticoagulant (such as warfarin) or postoperative heparin for more than 6 months
研究组 & 干预措施
Screw-Distraction (SD) group
six pedicle screws were implanted firstly, then distraction was achieved.
干预措施: fractured level screws-distraction (Device)
Distraction-Screw (DS) group
four pedicle screws were implanted firstly, then distraction was achieved, two additional screws were introduced at the fracture level at last.
干预措施: fractured level screws-distraction (Device)
结局指标
主要结局
compression ratio change of anterior border of vertebral body height
时间窗: preoperatively, intraoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively
using X-ray fluorescence
Depth of nail into injured vertebrae
时间窗: at postoperation immediately
using X-ray fluorescence
Kyphosis (Cobb) angle change
时间窗: preoperatively, intraoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively
using X-ray fluorescence
次要结局
- Operative time(right after surgery)
- The American Spinal Injury Association (ASIA) impairment scale(preoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively)
- intraoperative blood loss(right after surgery)
- Complications(at postoperation immediately, 1, 3 and 6 months, and at 1 and 2 years postoperatively.)
- pain degree of back and lower limb(preoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively.)
- Oswestry Disability Index (ODI) change(preoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively)
- The Japanese Orthopaedic Association (JOA) scores(preoperatively and postoperatively including day 3 and then 1, 3, 6, 12 and 24 months)