Xiaolong Shen1, Lei Wang, Hailong Zhang, Xin Gu, Guangfei Gu, Shisheng He. 1. *Department of Orthopedics, Shanghai Tenth People's Hospital†Department of Diagnostic Imaging, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.
Abstract
STUDY DESIGN: A prospective randomized study was conducted. OBJECTIVE: The purpose of this study was to assess the radiographic outcomes of one-level minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) with unilateral pedicle screw instrumentation for degenerative lumbar spine disease. SUMMARY OF BACKGROUND DATA: MI-TLIF has become an increasingly popular method of lumbar arthrodesis. Recent technological advances in spinal instrumentation have culminated in the development of MI-TLIF with unilateral pedicle screw fixation. However, there are few published studies on radiographic outcomes of the MI-TLIF with unilateral pedicle screw fixation. METHODS: A total of 65 patients with one-level degenerative lumbar spine disease were enrolled in this study. Patients were randomized into the unilateral or bilateral fixation group based on a computer-generated number list. Thirty-one patients (17 men and 14 women; average age, 57.3 y) were randomized to the unilateral group (group A) and 34 patients (16 men and 18 women; average age, 58.9 y) to the bilateral group (group B). All patients underwent minimally invasive decompression, interbody fusion, and pedicle screw fixation with the assistance of microscopic tubular retractor system (METRx-MD) and Sextant system. All patients were asked to follow-up at 3, 6, and thereafter once every 6 months after surgery. The visual analog scale (VAS), Oswestry disability index (ODI), and modified Prolo (mProlo) scores were obtained for all patients 24 hours before the operation and at each follow-up visit. The whole lumbar lordosis (WL), the segmental lordosis (SL), fusion level disk space angle, lumbar scoliosis angle, and segmental scoliosis angle were determined before and after surgery on standard x-rays. The disk height index (DI) and the lumber curvature index (LI) were also evaluated. RESULTS: The mean follow-up was 26.6 months, with a range of 18-36 months. All patients showed evidence of fusion at 12 months postoperatively. Statistically, there was no significant difference between the 2 groups in terms of demographic data. The average postoperative VAS, ODI, and mProlo scores improved significantly in each group. No significant differences were found between the 2 groups in relation to VAS, ODI, and mProlo scores at each follow-up time point. There were no significant differences between the 2 groups in relation to WL, SL, disk space angle, lumbar scoliosis angle, segmental scoliosis angle, DI, and LI. There was also no difference between postoperative different follow-up visits in terms of these radiographic parameters in both groups. There was a positive linear correlation between the LI and WL in both groups. CONCLUSIONS: One-level unilateral pedicle screw instrumented MI-TLIF provided similar radiologic and clinical outcomes to bilateral pedicle screw instrumented MI-TLIF. This study showed that MIS-TLIF with unilateral pedicle screw fixation would be sufficient in the management of preoperatively stable patients with lumbar degenerative disease.
RCT Entities:
STUDY DESIGN: A prospective randomized study was conducted. OBJECTIVE: The purpose of this study was to assess the radiographic outcomes of one-level minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) with unilateral pedicle screw instrumentation for degenerative lumbar spine disease. SUMMARY OF BACKGROUND DATA: MI-TLIF has become an increasingly popular method of lumbar arthrodesis. Recent technological advances in spinal instrumentation have culminated in the development of MI-TLIF with unilateral pedicle screw fixation. However, there are few published studies on radiographic outcomes of the MI-TLIF with unilateral pedicle screw fixation. METHODS: A total of 65 patients with one-level degenerative lumbar spine disease were enrolled in this study. Patients were randomized into the unilateral or bilateral fixation group based on a computer-generated number list. Thirty-one patients (17 men and 14 women; average age, 57.3 y) were randomized to the unilateral group (group A) and 34 patients (16 men and 18 women; average age, 58.9 y) to the bilateral group (group B). All patients underwent minimally invasive decompression, interbody fusion, and pedicle screw fixation with the assistance of microscopic tubular retractor system (METRx-MD) and Sextant system. All patients were asked to follow-up at 3, 6, and thereafter once every 6 months after surgery. The visual analog scale (VAS), Oswestry disability index (ODI), and modified Prolo (mProlo) scores were obtained for all patients 24 hours before the operation and at each follow-up visit. The whole lumbar lordosis (WL), the segmental lordosis (SL), fusion level disk space angle, lumbar scoliosis angle, and segmental scoliosis angle were determined before and after surgery on standard x-rays. The disk height index (DI) and the lumber curvature index (LI) were also evaluated. RESULTS: The mean follow-up was 26.6 months, with a range of 18-36 months. All patients showed evidence of fusion at 12 months postoperatively. Statistically, there was no significant difference between the 2 groups in terms of demographic data. The average postoperative VAS, ODI, and mProlo scores improved significantly in each group. No significant differences were found between the 2 groups in relation to VAS, ODI, and mProlo scores at each follow-up time point. There were no significant differences between the 2 groups in relation to WL, SL, disk space angle, lumbar scoliosis angle, segmental scoliosis angle, DI, and LI. There was also no difference between postoperative different follow-up visits in terms of these radiographic parameters in both groups. There was a positive linear correlation between the LI and WL in both groups. CONCLUSIONS: One-level unilateral pedicle screw instrumented MI-TLIF provided similar radiologic and clinical outcomes to bilateral pedicle screw instrumented MI-TLIF. This study showed that MIS-TLIF with unilateral pedicle screw fixation would be sufficient in the management of preoperatively stable patients with lumbar degenerative disease.
Authors: Hai Le; Ryan Anderson; Eileen Phan; Joseph Wick; Joshua Barber; Rolando Roberto; Eric Klineberg; Yashar Javidan Journal: Global Spine J Date: 2020-06-22