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AbstractObjectiveTo assess whether decompression alone is non-inferior to decompression with instrumented fusion five years after primary surgery in patients with degenerative lumbar spondylolisthesis.DesignFive year follow-up of a randomised, multicentre, non-inferiority trial (Nordsten-DS).Setting16 public orthopaedic and neurosurgical clinics in Norway.ParticipantsPatients aged 18-80 years with symptomatic lumbar spinal stenosis and a spondylolisthesis of 3 mm or more at the stenotic level.InterventionsDecompression surgery alone and decompression with additional instrumented fusion (1:1).Main outcome measuresThe primary outcome was a 30% or more reduction in Oswestry disability index from baseline to five year follow-up. The predefined non-inferiority margin was a −15 percentage point difference in the proportion of patients who met the primary outcome. Secondary outcomes included the mean change in Oswestry disability index, Zurich claudication questionnaire, numeric rating scale for leg and back pain, and EuroQol Group 5-Dimension (EQ-5D-3L) questionnaire.ResultsFrom 12 February 2014 to 18 December 2017, 267 participants were randomly assigned to decompression alone (n=134) and decompression with instrumented fusion (n=133). Of these, 230 (88%) responded to the five year questionnaire: 121 in the decompression group and 109 in the fusion group. Mean age at baseline was 66.2 years (SD 7.6), and 69% were women. In the modified intention-to-treat analysis with multiple imputation of missing data, 84 (63%) of 133 people in the decompression alone group and 81 (63%) of 129 people in the fusion group had a at least a 30% reduction in Oswestry disability index, a difference of 0.4 percentage points. (95% confidence interval (CI) −11.2 to 11.9). The respective results of the per protocol analysis were 65 (65%) of 100 in the decompression alone group and 59 (66%) of 89 in the fusion group, a difference of −1.3 percentage points (95% CI −14.5 to 12.2). Both 95% CIs were higher than the predefined non-inferiority margin of −15%. The mean change in Oswestry disability index from baseline to five years was −17.8 in both groups (mean difference 0.02 (95% CI −3.8 to 3.9)). Results of the other secondary outcomes were in the same direction as the primary outcome. From two to five year follow-up, a new lumbar operation occurred in six (5%) of 123 people in the decompression group and 11 (10%) of 113 people in the fusion group, with a total from baseline to five years of 21 (16%) of 129 people and 23 (18%) of 125, respectively.ConclusionsIn participants with degenerative spondylolisthesis, decompression alone was non-inferior to decompression with instrumented fusion five years after primary surgery. Proportions of subsequent surgeries at the index level or an adjacent lumbar level were no different between the groups.Trial registrationClinicalTrials.gov NCT02051374

Background Cage subsidence (CS) was previously reported as one of the most common complications following oblique lumbar interbody fusion (OLIF). We aimed to assess the impacts of CS on surgical results following OLIF combined with anterolateral fixation, and determine its radiological characteristics as well as related risk factors. Methods Two hundred and forty-two patients who underwent OLIF at L4-5 and with a minimum 12 months follow-up were reviewed. Patients were divided into three groups according to the extent of disk height (DH) decrease during follow-up: no CS (DH decrease ≤ 2 mm), mild CS (2 mm < DH decrease ≤ 4 mm) and severe CS (DH decrease > 4 mm). The clinical and radiological results were compared between groups to evaluate radiological features, clinical effects and risk factors of CS. Results CS was identified in 79 (32.6%) patients, including 48 (19.8%) with mild CS and 31 (11.8%) with severe CS. CS was mainly identified within 1 month postoperatively, it did not progress after 3 months postoperatively, and more noted in the caudal endplate (44, 55.7%). In terms of clinical results, patients in the mild CS group were significantly worse than those in the no CS group, and patients in the severe CS group were significantly worse than those in the mild CS group. There was no significant difference in fusion rate between no CS (92.6%, 151/163) and mild CS (83.3%, 40/48) groups. However, significant lower fusion rate was observed in severe CS group (64.5%, 20/31) compared to no CS group. CS related risk factors included osteoporosis (OR = 5.976), DH overdistraction (OR = 1.175), flat disk space (OR = 3.309) and endplate injury (OR = 6.135). Conclusion CS following OLIF was an early postoperative complication. Higher magnitudes of CS were associated with worse clinical improvements and lower intervertebral fusion. Osteoporosis and endplate injury were significant risk factors for CS. Additionally, flat disk space and DH over-distraction were also correlated with an increased probability of CS.

BACKGROUND:Sacroiliac joint (SIJ) dysfunction is a prevalent cause of chronic, unremitting lower back pain. OBJECTIVE:To concurrently compare outcomes after surgical and nonsurgical treatment for chronic SIJ dysfunction. METHODS:A total of 148 subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (n = 102) or nonsurgical management (n = 46). Pain, disability, and quality-of-life scores were collected at baseline and at 1, 3, 6, and 12 months. Success rates were compared using Bayesian methods. Crossover from nonsurgical to surgical care was allowed after the 6-month study visit was complete. RESULTS:Six-month success rates were higher in the surgical group (81.4% vs 26.1%; posterior probability of superiority > 0.9999). Clinically important (≥ 15 point) Oswestry Disability Index improvement at 6 months occurred in 73.3% of the SIJ fusion group vs 13.6% of the nonsurgical management group (P < .001). At 12 months, improvements in SIJ pain and Oswestry Disability Index were sustained in the surgical group. Subjects who crossed over had improvements in pain, disability, and quality of life similar to those in the original surgical group. Adverse events were slightly more common in the surgical group (1.3 vs 1.1 events per subject; P = .31). CONCLUSION:This Level 1 study showed that minimally invasive SIJ fusion using triangular titanium implants was more effective than nonsurgical management at 1 year in relieving pain, improving function, and improving quality of life in patients with SIJ dysfunction caused by degenerative sacroiliitis or SIJ disruptions. Pain, disability, and quality of life also improved after crossover from nonsurgical to surgical treatment. ABBREVIATIONS:EQ-5D, EuroQoL-5DINSITE, Investigation of Sacroiliac Fusion TreatmentMCS, mental component summaryNSM, nonsurgical managementODI, Oswestry Disability IndexPCS, physical component summaryRFA, radiofrequency ablationSF-36, Short Form-36SIJ, sacroiliac jointTTO, time trade-offVAS, visual analog scale

Abstract BACKGROUND In minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF), cage type and position play important roles in fusion achievement and sagittal alignment correction. However, no prospective randomized comparison of the results using different types of cage has been reported to date. OBJECTIVE To compare the radiological and clinical outcomes of unilateral MIS-TLIF using 2 types of cage. METHODS All candidates for single-level MIS-TLIF were randomized into banana-shaped cage and straight-cage groups. Plain radiographs and computed tomography scans were used for assessment of cage positions, fusion status, disc height, segmental lordotic angle, cage subsidence, and pelvic parameters. Clinical outcome was assessed using visual analog scale and Oswestry Disability Index scores. RESULTS Forty-four and 40 consecutive patients were operated on using banana-shaped and straight cages, respectively. Cage position was more anterior and lateral in the straight-cage group and more medial and posterior in the banana-shaped cage group. Solid fusion was achieved in 95.2% and 96.6% of the 2 groups, respectively, at 12 mo. The change in disc height and segmental lordotic angle postoperatively was significantly greater in the banana-shaped cage group. The incidence of subsidence during follow-up was significantly higher in the banana-shaped cage group (P < .04). Clinically, the visual analog scale and Oswestry Disability Index scores decreased significantly after surgery in both groups, with no significant difference between the groups. CONCLUSION Our preliminary outcomes suggest that the subsidence rate may be higher using banana-shaped cages in MIS-TLIF, possibly due to their more medial final position.

Background Cervical spondylosis (CS), including myelopathy and radiculopathy, is the most common degenerative cervical spine disease. This study aims to evaluate the clinical outcomes of unilateral biportal endoscopy (UBE) compared to those of conventional anterior cervical decompression and fusion (ACDF) for treating unilateral cervical radiculopathy or coexisting cervical myelopathy induced by unilateral cervical herniated discs. Methods A prospective, randomized, controlled, noninferiority trial was conducted. The sample consisted of 131 patients who underwent UBE or ACDF was conducted between September 2021 and September 2022. Patients with cervical nerve roots or coexisting spinal cord compression symptoms and imaging-defined unilateral cervical radiculopathy or coexisting cervical myelopathy induced by unilateral cervical herniated discs were randomized into two groups: a UBE group ( n  = 63) and an ACDF group ( n  = 68). The operative time, blood loss, length of hospital stay after surgery, and perioperative complications were recorded. Preoperative and postoperative modified Japanese Orthopaedic Association (mJOA) scale scores, visual analog scale (VAS) scores, neck disability index (NDI) scores, and recovery rate (RR) of the mJOA were utilized to evaluate clinical outcomes. Results The hospital stay after surgery was significantly shorter in patients treated with UBE than in those treated with ACDF ( p  < 0.05). There were no significant differences in the neck or arm VAS score, NDI score, mJOA score, or mean RR of the mJOA between the two groups ( p  < 0.05). Only mild complications were observed in both groups, with no significant difference ( p  = 0.30). Conclusion UBE can significantly relieve pain and disability without severe complications, and most patients are satisfied with this technique. Consequently, this procedure can be used safely and effectively as an alternative to ACDF for treating unilateral cervical radiculopathy or coexisting cervical myelopathy induced by unilateral cervical herniated discs. Trial registration This study was registered in the Chinese Clinical Trial Registry on 02/08/2023 ( http://www.chictr.org.cn , #ChiCTR2300074273).

Purpose To evaluate the effectiveness of an evidence-based pre-, peri- and postoperative rehabilitation pathway (i.e. the REACT rehabilitation pathway) on disability in patients undergoing lumbar fusion surgery (LFS), compared to usual care. Methods A prospective, nonrandomized controlled trial included 72 patients scheduled for one- or two-level LFS for degenerative conditions or adult isthmic spondylolisthesis. Participants were allocated to usual care (N = 36) or the REACT rehabilitation pathway (N = 36). The REACT rehabilitation pathway includes prehabilitation, early mobilization and avoidance of unsubstantiated postoperative restrictions, early postoperative physiotherapy, patient empowerment, case manager guidance, and support towards an early return to activity. The primary outcome was disability; key secondary outcomes were back and leg pain intensity, and return-to-work rate. Additional secondary outcomes included fear of movement, pain catastrophizing, negative emotional states, sit-to-stand performance, analgesic use, length of stay, and adverse events. Data were collected preoperatively and at five time points up to one year postoperatively. Results Participants in the REACT group demonstrated significantly greater improvements in disability ( p  = 0.003), back pain intensity ( p  = 0.007), and return-to-work rates (88% vs 56%, p  = 0.34) compared to the control group. The REACT group also showed greater improvements in fear of movement ( p  = 0.038), pain catastrophizing ( p  < 0.001), combined negative emotional states ( p  = 0.007), sit-to-stand performance ( p  = 0.021), and reduced analgesic use ( p  = 0.001). No significant differences were observed in leg pain intensity ( p  = 0.042), length of hospital stay ( p  = 0.095) or adverse events ( p  = 1.00). Conclusion The REACT rehabilitation pathway significantly reduced disability in the first postoperative year after LFS compared to usual care. The most promising result is the significantly higher return-to-work rate in the REACT group.

Minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) and percutaneous endoscopic TLIF (PE-TILF) have been widely used in spine surgery. The use of a robot-guided technique provided several advantages; however, few studies have investigated the clinical outcomes of robot-assisted PE-TLIF (PE RA-TLIF). The aim of this prospective cohort study was to compare the clinical outcomes of PE RA-TLIF with MIS-TLIF for the treatment of lumbar 4-5 (L4-5) spondylolisthesis. Prospective cohort study. Qilu Hospital of Shandong University. Fifty-eight cases diagnosed with L4-5 spinal stenosis with instability and Meyerding grade I spondylolisthesis (degenerative spondylolisthesis or isthmic spondylolisthesis) were included in this study. Twenty-six patients (group A) were treated with PE RA-TLIF, and the others (group B) underwent MIS-TLIF. The surgical procedures for PE RA-TLIF included the percutaneous implantation of pedicle screws (PS) under robot guidance, percutaneous fully endoscopic transforaminal decompression, and interbody fusion. The Japanese Orthopedic Association (JOA) score, the visual analog scale (VAS) for low back pain (LBP), the VAS for leg pain/numbness, and the Oswestry disability index (ODI) were used as follow-up clinical outcomes, and the lumbar interbody fusion rate was evaluated by CT. All statistical analyses were performed with SPSS 22.0, and the results were presented as mean ± standard deviation (SD). There were 4 cases of spinal stenosis with instability, 17 cases of degenerative spondylolisthesis, and 5 cases of isthmic spondylolisthesis in group A. For group B, there were 6 cases of spinal stenosis with instability, 19 cases of degenerative spondylolisthesis, and 7 cases of isthmic spondylolisthesis. The preoperative scores for the JOA, ODI, VAS for LBP, and VAS for leg pain were not statistically comparable between the 2 groups (P > 0.05). The incision length for decompression and interbody fusion, estimated blood loss (EBL), and 1-day and 3-day incision pain were significantly higher in group B than in group A (P < 0.05). The mean operative time was longer in group A than in group B (P < 0.05). The operation time of the first 10 cases (251 ± 24 min) was much longer than that of the last 16 cases (200 ± 17 min) in group A. The misplacement rate of percutaneous pedicle screw placement was higher in group B (P < 0.05). No infections of incisions and interbody or nerve root or dural injuries were found in either group A or B. No differences were found between the 2 groups in the JOA scores, ODI, leg pain VAS score, or lumbar interbody fusion rate at the 2-year follow-up. The VAS for back pain was better in group A than in group B (P < 0.05). The PE RA -TLIF procedure is technically challenging and has a steep learning curve, and the study was not strictly randomized. PE RA-TLIF is a safe and effective procedure that can significantly improve the accuracy of pedicle screw placement, reduce surgical trauma, and facilitate rapid postoperative recovery. However, this technique has a steep and long learning curve and requires long-term follow-ups.

Objective To compare the safety and accuracy of cortical bone trajectory screw placement between the robot-assisted and fluoroscopy-assisted approaches. Methods This retrospective study was conducted between November 2018 and June 2020, including 81 patients who underwent cortical bone trajectory (CBT) surgery for degenerative lumbar spine disease. CBT was performed by the same team of experienced surgeons. The patients were randomly divided into two groups—the fluoroscopy-assisted group (FA, 44 patients) and the robot-assisted group (RA, 37 patients). Robots for orthopedic surgery were used in the robot-assisted group , whereas conventional fluoroscopy-guided screw placement was used in the fluoroscopy-assisted group. The accuracy of screw placement and rate of superior facet joint violation were assessed using postoperative computed tomography (CT). The time of single screw placement, intraoperative blood loss, and radiation exposure to the surgical team were also recorded. The χ 2 test and Student’s t-test were used to analyze the significance of the variables ( P  < 0.05). Results A total of 376 screws were inserted in 81 patients, including 172 screws in the robot-assisted group and 204 pedicle screws in the fluoroscopy-assisted group. Screw placement accuracy was higher in the RA group (160, 93%) than in the FA group (169, 83%) ( P  = 0.003). The RA group had a lower violation of the superior facet joint than the FA group. The number of screws reaching grade 0 in the RA group (58, 78%) was more than that in the FA group (56, 64%) ( P  = 0.041). Screw placement time was longer in the FA group (7.25 ± 0.84 min) than in the RA group (5.58 ± 1.22 min, P  < 0.001). The FA group had more intraoperative bleeding (273.41 ± 118.20 ml) than the RA group (248.65 ± 97.53 ml, P  = 0.313). The radiation time of the FA group (0.43 ± 0.07 min) was longer than the RA group (0.37 ± 0.10 min, P  = 0.001). Furthermore, the overall learning curve tended to decrease. Conclusions Robot-assisted screw placement improves screw placement accuracy, shortens screw placement time, effectively improves surgical safety and efficiency, and reduces radiation exposure to the surgical team. In addition, the learning curve of robot-assisted screw placement is smooth and easy to operate.

Background and purpose Although navigation is increasingly used in spinal surgery, the advantage of different navigation technologies is still a matter of debate. Conventional image-guided navigation is currently the gold standard. However, modern, Augmented reality-based navigation methods are increasingly gaining ground. Surgical navigation in deformity surgery allows placement of pedicle screws in small and deformed pedicles and may result in both a higher accuracy and density of pedicle screw placement. The aim of this trial is to compare AR and conventional surgical navigation to free-hand technique. Patients and methods This is a single center, open label, parallel assignment, three arm, randomized, controlled trial, comparing: Augmented reality surgical navigation (ARSN), Infrared surgical navigation (IRSN) and Free-hand (FH) technique. Individuals scheduled for spinal deformity surgery are eligible for inclusion. The inclusion criteria are written informed consent, age ≥ 12 years and spinal deformity. Subjects will be randomized intraoperatively and strictly sequentially. Outcomes The primary endpoint is accurately placed pedicle screws based on intraoperative verification cone beam computed tomography (CBCT) scan. All radiological image analyses, on both intra- and postoperative imaging will be performed postoperatively by blinded reviewers. Several secondary outcome measures including revision rate, radiation exposure, implant density and final accuracy will be analyzed. Patient reported outcomes will also be assessed. Finally, a cost–benefit analysis will be performed. Start of trial and estimated duration The SPINAV trial started recruiting patients in January 2022 and will continue for approximately 2.5 years. Trial registration The trial is registered at clinicaltrials.gov (NCT05107310) on 2021–11-03.

To evaluate the curative efficacy by comparing perioperative characteristics and 1.5-year observational outcomes in 1-segment lumbar spondylolisthesis between traditional minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) and optimized Endoscopic TLIF techniques. The study was a single-center, randomized controlled trial comparing two different treatment approaches for 1-segment lumbar spondylolisthesis. 102 patients treated by MIS-TLIF (48 cases) or Endo-TLIF (54 cases) were included from March 2018 to April 2019. Perioperative parameters and clinical outcomes were evaluated. Degree of slip were measured, and fusion rates were determined at 18 months after surgery. The Endo-TLIF group had similar return to work time and rate. Blood loss, left bed time, analgesic ratio were significantly less in Endo-TLIF group. The Endo-TLIF group had a significantly longer operative time. Significant postoperative reduction in %slip was showed in both groups. The VAS and ODI improved significantly in both groups after surgery. Significant decreases in low-back pain in Endo-TLIF group were found at postoperative day 1 and 3 months. The fusion rate in the two groups was similar. Endo-TLIF surgery with a C-shaped working tube and a visualization system may be regarded as an efficient alternative surgery for 1-segment lumbar spondylolisthesis. It is a safe and minimally invasive way to perform this surgery and has shown satisfactory clinical outcomes. ChiCTR1800015197, 13 March 2018. Trial registry: Chinese Clinical Trial Registry. Registered 13 March 2018. http://www.chictr.org.cn/showproj.aspx?proj=25865 •Endo-TLIF achieve maximal preservation of normal musculo-ligamentous and bone structures.•The novel C-shaped working cannula place the cage into intervertebral space safely and quickly.•Endo-TLIF has a more positive influence in improving postoperative LBP and analgesic ratio.•Endo-TLIF manifests less normal tissue damage, faster recovery.