Surgical Treatment of the Thoracolumbar Spine Fractures - Conventional Open Surgery Versus Minimally Invasive Percutaneous Surgery: A Randomized Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Postoperative pain
研究概览
简要总结
The thoracolumbar segment fractures are the most frequent along the spine, and surgical treatment is indicated in unstable fractures. Surgical treatment has been performed through the posterior fixation pedicle fixation systems, and where necessary complemented by decompression of the spinal arthrodesis and previous channel. Surgical treatment has been performed by conventional open approach through the posterior incision on the midline, and detachment and removal of paraspinal muscles to access the posterior vertebral elements. The percutaneous minimally invasive surgery was introduced in the context of spinal surgery to reduce the morbidity associated with conventional open approach. It has been reported the lowest bleeding intra- and postoperative period, less pain, shorter hospital stay, rehabilitation and return to work faster with less use of minimally invasive percutaneous approach of the spine. However, predominates in the literature of clinical case reports and few prospective and randomized clinical trials. The performance of prospective randomized clinical trials have been required for the evaluation of the benefits of minimally invasive surgery in the treatment of the thoracolumbar spine fractures. The objective of the study is to compare the surgical treatment of fractures of the thoracolumbar spine using the conventional open approach or minimally invasive percutaneous approach to the stabilization of the vertebral segment affected, and using similar type of pedicle spinal fixation system. Patients will be evaluated in the preoperative, postoperative, 1,2,3,6,12 and 24 months by parameters related to the perioperative (intraoperative bleeding, surgery time), clinical (VAS, SF-36, HADS, EQ-5D-5L), images (radiographs and computed tomography). The study results will impact the guidelines of the surgical treatment of thoracolumbar spine fractures and may indicate the advantages or disadvantages of using surgery through conventional open approach to minimally invasive percutaneous surgery.
详细描述
Introduction: Fractures of the thoracic and lumbar spine are the most frequent fractures of the axial skeleton, and correspond to about 89% of vertebral fractures. Two-thirds of these fractures occur in the thoracolumbar transition between T11 and L2 (50% of thoracic spine fractures at T12 level and 60% of lumbar spine fractures at L1 level). Surgical treatment of thoracolumbar spine fractures has been indicated in unstable fractures with the aim of stabilizing the fractured vertebral segment and allowing early rehabilitation without the use of external immobilization and rest in the bed. Conventional surgical treatment has been performed by means of fixation and posterior arthrodesis of the vertebral segment using pedicle fixation systems with or without arthrodesis The scientific challenge of the project is to carry out this method of pioneering study in our country, as no prospective randomized clinical trial has been performed in our country to compare the outcome of surgical treatment of thoracolumbar spine fractures through conventional open surgery or surgery Minimally invasive percutaneous. There are few reports of prospective and randomized trials on this subject and its implementation has been stimulated to increase the level of evidence related to the surgical treatment of thoracolumbar spine fractures.
The objective of the study will be to compare the results of treatment of thoracolumbar spine fractures through the open approach (conventional surgery) or percutaneous (minimally invasive) approach with a pedicle fixation system without vertebral arthrodesis.
The hypothesis of the study is that minimally invasive percutaneous surgery has the advantage of producing less surgical trauma with less intra- and postoperative bleeding, lower pain intensity, shorter hospitalization time and lower rate of complications, and postero-lateral arthrodesis Is not required in the treatment of thoracolumbar spine fractures.
Material and methods
After the clinical and radiographic evaluation (simple radiographs, CT and MRI if necessary) of the patients the fracture will be classified according to the classification Magerl et al., and the therapeutic planning defined. Fractures with surgical indication by means of the posterior approach will be selected for the study and the randomization process performed individually for each type of fracture (A, B and C) according to the Magerl classification. Patients will be randomized and assigned to two groups: A - conventional open surgery and B - minimally invasive percutaneous surgery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single level fracture
- •Fracture T11-L5
- •Posterior Stabilization Indication
排除标准
- •Fracture in more than 1 level
- •Osteoporotic fracture
- •Pathological fracture
- •Previous history of surgery
- •Deformity
- •Mental disease
- •Posterior vertebral canal open decompression
结局指标
主要结局
Postoperative pain
时间窗: up to 24 months
The intensity of pain will be measured by Visual Analogue Scale (VAS).
次要结局
- Breakage or release of implants through radiographs(immediate postoperative, and 1,2,3,6,12 and 24 months of followup)
- Length of hospital stay (in days)(At discharge (up to two week post-surgery))
- Intraoperative bleeding (ml)(48 hours postoperative)
- EuroQol five-dimensional questionnaire (EQ-5D-5L)(1,2,3,6,12 and 24 months.)
- Postoperative complications(immediate postoperative, and 1,2,3,6,12 and 24 months of followup)
- Hospital Anxiety Depression Scale (HADS)(1,2,3,6,12 and 24 months.)
- Fractured vertebral body height(preoperative, immediate postoperative, and 1,2,3,6,12 and 24 months of followup)
- Breakage or release of implants through CT scan(immediate postoperative, and 1,2,3,6,12 and 24 months of followup)
- Postoperative bleeding (ml)(48 hours postoperative)
- Intraoperative fluoroscopy time (in minutes)(Intraoperative)
- Postoperative adverse events(immediate postoperative, and 1,2,3,6,12 and 24 months of followup)
- Total costs(24 months)
- Surgery time (in minutes)(Intraoperative)
- Short Form Health Survey (SF-36)(1,2,3,6,12 and 24 months.)
- Accuracy of the pedicle screws(preoperative, immediate postoperative, and 1,2,3,6,12 and 24 months of followup)
- Vertebral segment kyphosis(preoperative, immediate postoperative, and 1,2,3,6,12 and 24 months of followup)
- Compression of the vertebral canal(preoperative, immediate postoperative, and 1,2,3,6,12 and 24 months of followup)
研究者
Helton Defino
PhD in Orthopedics and Traumatology
University of Sao Paulo