Ming Yang1, Qinpeng Zhao1, Dingjun Hao1, Zhen Chang1, Shichang Liu2, Xinhua Yin3. 1. Department of Spinal Surgery, Hong Hui Hospital, Xi'an Jiaotong University College of Medicine, 555 Friendship East Road, Xi'an, 710054, Shanxi, China. 2. Department of Spinal Surgery, Hong Hui Hospital, Xi'an Jiaotong University College of Medicine, 555 Friendship East Road, Xi'an, 710054, Shanxi, China. 1244904499@qq.com. 3. Department of Spinal Surgery, Hong Hui Hospital, Xi'an Jiaotong University College of Medicine, 555 Friendship East Road, Xi'an, 710054, Shanxi, China. xinhuayin1@sina.com.
Abstract
OBJECTIVES: To compare the efficacy and safety of novel percutaneous minimally invasive pedicle screw fixation and traditional open surgery for thoracolumbar fractures without neurological deficit. METHODS:Sixty adult patients with single thoracolumbar fracture between June 2014 and June 2016 were recruited in this study, randomly divided into open fixation group (group A) or minimally invasive percutaneous fixation group (group B). Clinical and surgical evaluation including surgery time, blood losses, radiation times, hospital stay, and complication were performed. The two groups of patients with pre-operative and last follow-up anterior height ratio of fracture vertebral, Cobb angle of fracture vertebral, and VAS score of back pain were compared. RESULTS: All patients completed valid follow-ups, with an average time period of 15.4 months (12-26 months). Group B achieved much better results in time of operation, intra-operative blood loss, and length of stay than group A (P < 0.05). Group A was significantly better than group B in the times of radiation (P < 0.05). The VAS score was significantly lower in group B than in group A at three days after the operation (P < 0.05). There were no significant differences between the two groups in the anterior height ratio of fracture vertebral, Cobb angle, and VAS score in the last follow-up (P > 0.05). No injured nerve or other severe complications occurred in both groups; one of the patients from group A had back and loin pain lasting for about one month, which resolved after analgesia and functional training. There was no significant difference between the two groups in incidence of complications. CONCLUSIONS: Novel percutaneous pedicle screws with angle reset function can achieve the same effect as traditional open pedicle screw fixation in the treatment of thoracolumbar fractures without nerve injuries. Percutaneous minimally invasive pedicle screw fixation has the characteristics of shorter operative time, less bleeding, and less pain, but it needs more radiation times.
RCT Entities:
OBJECTIVES: To compare the efficacy and safety of novel percutaneous minimally invasive pedicle screw fixation and traditional open surgery for thoracolumbar fractures without neurological deficit. METHODS: Sixty adult patients with single thoracolumbar fracture between June 2014 and June 2016 were recruited in this study, randomly divided into open fixation group (group A) or minimally invasive percutaneous fixation group (group B). Clinical and surgical evaluation including surgery time, blood losses, radiation times, hospital stay, and complication were performed. The two groups of patients with pre-operative and last follow-up anterior height ratio of fracture vertebral, Cobb angle of fracture vertebral, and VAS score of back pain were compared. RESULTS: All patients completed valid follow-ups, with an average time period of 15.4 months (12-26 months). Group B achieved much better results in time of operation, intra-operative blood loss, and length of stay than group A (P < 0.05). Group A was significantly better than group B in the times of radiation (P < 0.05). The VAS score was significantly lower in group B than in group A at three days after the operation (P < 0.05). There were no significant differences between the two groups in the anterior height ratio of fracture vertebral, Cobb angle, and VAS score in the last follow-up (P > 0.05). No injured nerve or other severe complications occurred in both groups; one of the patients from group A had back and loin pain lasting for about one month, which resolved after analgesia and functional training. There was no significant difference between the two groups in incidence of complications. CONCLUSIONS: Novel percutaneous pedicle screws with angle reset function can achieve the same effect as traditional open pedicle screw fixation in the treatment of thoracolumbar fractures without nerve injuries. Percutaneous minimally invasive pedicle screw fixation has the characteristics of shorter operative time, less bleeding, and less pain, but it needs more radiation times.