Open versus minimally invasive percutaneous surgery for surgical treatment of thoracolumbar spine fractures- a multicenter randomized controlled trial: study protocol

Abstract

Background Thoracolumbar fractures are most frequent along the spine, and surgical treatment is indicated for unstable fractures. Percutaneous minimally invasive surgery was introduced to reduce the pain associated with the open posterior approach and reduce the morbidity of the procedure by avoiding damage and dissection of the paravertebral muscles. The goal of this study is to compare the surgical treatment of fractures of the thoracolumbar spine treated by the conventional open approach and the percutaneous minimally invasive approach using similar types of pedicle spine fixation systems. Methods/designs This study is designed as a multi-center, randomized controlled trial of patients aged 18–65 years who are scheduled to undergo surgical posterior fixation. Treatment by the conventional open approach or percutaneous minimally invasive approach will be randomly assigned. The primary outcome measure is postoperative pain, which will be measured using the visual analogue scale (VAS). The secondary outcome parameters are intraoperative bleeding, postoperative drainage, surgery time, length of hospital stay, SF-36, EQ-5D-5 l, HADS, pain medication, deambulation after surgery, intraoperative fluoroscopy time, vertebral segment kyphosis, fracture vertebral body height, compression of the vertebral canal, accuracy of the pedicle screws, and breakage or release of the implants. Patient will be followed up for 1, 2, 3, 6, 12 and 24 months postoperatively and evaluated according to the outcomes using clinical and radiological examinations, plain radiographs and computed tomografy (CT). Discussion Surgical treatment of thoracolumbar fractures by the open or percutaneous minimally invasive approach will be compared in a multicenter randomized study using similar types of fixation systems, and the results will be evaluated according to clinical and radiological parameters at 1, 2, 3, 6, 12 and 24 months of follow-up. Trial registration ClinicalTrial.gov approval number: 1.933.631, code: NCT03316703 in may 2017.

Systematic review and meta-analysis of the effect of using percutaneous pedicle screw internal fixation for thoracolumbar fractures

“…Currently, posterior pedicle screw fixation is the most widely used method in clinical practice. Numerous clinical studies have shown that this method can immediately restore normal spinal sequence reconstruction and maintain spinal stability (9). However, this traditional surgical method also has significant disadvantages such as the method for patients with traumatic big, long operation time, intraoperative blood loss, and longer duration of postoperative pain in patients with incision, generally required long-term postoperative incision drainage tube, leading to stay in bed longer hospitalization and recovery.…”

Global French Spine Surgery Activity: Executive Report of Demographics Data and Trends

“…The progress of surgical techniques in these indications has evolved considerably with the development of percutaneous surgery. Several studies have shown that the minimally invasive percutaneous procedure results in less damage to the paraspinal muscles, minimized blood loss, and reduced operating time, with almost similar results in terms of stabilization [18][19][20]. The advent of these techniques also makes it possible to offer surgical solutions to older patients who did not have access to them before.…”

Percutaneous Uniplanar Pedicle Screw-Rod System with Injured Vertebra Fixation for Thoracolumbar Burst Fracture and Technique Notes

“…However, the traditional procedure has disadvantages of long operative time, large blood loss, posterior ligaments complex injury, high infection rate, and persistent postoperative low back pain, which significantly affect the patient's quality of life. 9 With the development of minimally invasive concepts and minimally invasive surgery, percutaneous pedicle screw has various advantages, including less trauma, less bleeding, short operation time, and quick recovery. 10 It is an ideal method for patients suffering from thoracolumbar burst fracture with mild or without obvious lower-extremity neurological symptoms.…”