Safety and accuracy of robot-assisted versus fluoroscopy-assisted pedicle screw insertion in thoracolumbar spinal surgery: a prospective randomized controlled trial

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Abstract

OBJECTIVE

The object of this study was to compare the safety and accuracy of pedicle screw placement using the TiRobot system versus conventional fluoroscopy in thoracolumbar spinal surgery.

METHODS

Patients with degenerative or traumatic thoracolumbar spinal disorders requiring spinal instrumentation were randomly assigned to either the TiRobot-assisted group (RG) or the freehand fluoroscopy-assisted group (FG) at a 1:1 ratio. The primary outcome measure was the accuracy of screw placement according to the Gertzbein-Robbins scale; grades A and B (pedicle breach < 2 mm) were considered clinically acceptable. In the RG, discrepancies between the planned and actual screw placements were measured by merging postoperative CT images with the trajectory planning images. Secondary outcome parameters included proximal facet joint violation, duration of surgery, intraoperative blood loss, conversion to freehand approach in the RG, postoperative hospital stay, and radiation exposure.

RESULTS

A total of 1116 pedicle screws were implanted in 234 patients (119 in the FG, and 115 in the RG). In the RG, 95.3% of the screws were perfectly positioned (grade A); the remaining screws were graded B (3.4%), C (0.9%), and D (0.4%). In the FG, 86.1% screws were perfectly positioned (grade A); the remaining screws were graded B (7.4%), C (4.6%), D (1.4%), and E (0.5%). The proportion of clinically acceptable screws was significantly greater in the RG than in the FG (p < 0.01). In the RG, the mean deviation was 1.5 ± 0.8 mm for each screw. The most common direction of screw deviation was lateral in the RG and medial in the FG. Two misplaced screws in the FG required revision surgery, whereas no revision was required in the RG. None of the screws in the RG violated the proximal facet joint, whereas 12 screws (2.1%) in the FG violated the proximal facet joint (p < 0.01). The RG had significantly less blood loss (186.0 ± 255.3 ml) than the FG (217.0 ± 174.3 ml; p < 0.05). There were no significant differences between the two groups in terms of surgical time and postoperative hospital stay. The mean cumulative radiation time was 81.5 ± 38.6 seconds in the RG and 71.5 ± 44.2 seconds in the FG (p = 0.07). Surgeon radiation exposure was significantly less in the RG (21.7 ± 11.5 μSv) than in the FG (70.5 ± 42.0 μSv; p < 0.01).

CONCLUSIONS

TiRobot-guided pedicle screw placement is safe and useful in thoracolumbar spinal surgery.

Clinical trial registration no.: NCT02890043 (clinicaltrials.gov)

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Most cited references 15

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Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study.

Alexander Bruskin, Ioannis Pechlivanis, Rupert H J Dietl … (2010)

Retrospective, multicenter study of robotically-guided spinal implant insertions. Clinical acceptance of the implants was assessed by intraoperative radiograph, and when available, postoperative computed tomography (CT) scans were used to determine placement accuracy. To verify the clinical acceptance and accuracy of robotically-guided spinal implants and compare to those of unguided free-hand procedures. SpineAssist surgical robot has been used to guide implants and guide-wires to predefined locations in the spine. SpineAssist which, to the best of the authors' knowledge, is currently the sole robot providing surgical assistance in positioning tools in the spine, guided over 840 cases in 14 hospitals, between June 2005 and June 2009. Clinical acceptance of 3271 pedicle screws and guide-wires inserted in 635 reported cases was assessed by intraoperative fluoroscopy, where placement accuracy of 646 pedicle screws inserted in 139 patients was measured using postoperative CT scans. Screw placements were found to be clinically acceptable in 98% of the cases when intraoperatively assessed by fluoroscopic images. Measurements derived from postoperative CT scans demonstrated that 98.3% of the screws fell within the safe zone, where 89.3% were completely within the pedicle and 9% breached the pedicle by up to 2 mm. The remaining 1.4% of the screws breached between 2 and 4 mm, while only 2 screws (0.3%) deviated by more than 4 mm from the pedicle wall. Neurologic deficits were observed in 4 cases yet, following revisions, no permanent nerve damage was encountered, in contrast to the 0.6% to 5% of neurologic damage reported in the literature. SpineAssist offers enhanced performance in spinal surgery when compared to free-hand surgeries, by increasing placement accuracy and reducing neurologic risks. In addition, 49% of the cases reported herein used a percutaneous approach, highlighting the contribution of SpineAssist in procedures without anatomic landmarks.

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Complications of pedicle screws in lumbar and lumbosacral fusions in 105 consecutive primary operations.

Douglas Jutte, René Castelein (2002)

Pedicle screw fixation is technically demanding and associated with high complication rates. The aim of this study was to identify and quantify the pedicle screw-related complications in 105 consecutive operations. We retrospectively analysed 105 consecutive primary operations. We found complications of varying severity in 54% of the patients. Deep infections were found in 4.7%, all successfully cured by debridement and antibiotics. There were no permanent neurological complications related to the screws. One serious neurological sequela, a T10 paraplegia, was unrelated to screw placement between L3 and S1. Screw misplacement was found in 6.5% of the screws. Screw breakage occurred in 12.4% of the patients, inevitably leading to loss of correction. Reduced spondylolisthesis L5-S1 without anterior support was found to be especially prone to screw breakage. The study confirmed that pedicle screw placement is a technically demanding procedure with a high complication rate. Fortunately, most complications are not severe. Infections can be dealt with by thorough debridement and parenteral antibiotics. Neurological sequelae can be minimised by careful tactile technique. To avoid screw breakage and subsequent loss of correction, anterior support should be provided, through either posterior or anterior lumbar interbody fusion (PLIF or ALIF) techniques, in reduced spondylolisthesis L5-S1.