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Background: The comparative effectiveness of decompression plus lumbar facet arthroplasty versus decompression plus instrumented lumbar spinal fusion in patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis is unknown., Methods: In this randomized, controlled, Food and Drug Administration Investigational Device Exemption trial, we assigned patients who had single-level lumbar spinal stenosis and grade-I degenerative spondylolisthesis to undergo decompression plus lumbar facet arthroplasty (arthroplasty group) or decompression plus fusion (fusion group). The primary outcome was a predetermined composite clinical success score. Secondary outcomes included the Oswestry Disability Index (ODI), visual analog scale (VAS) back and leg pain, Zurich Claudication Questionnaire (ZCQ), Short Form (SF)-12, radiographic parameters, surgical variables, and complications., Results: A total of 321 adult patients were randomized in a 2:1 fashion, with 219 patients assigned to undergo facet arthroplasty and 102 patients assigned to undergo fusion. Of these, 113 patients (51.6%) in the arthroplasty group and 47 (46.1%) in the fusion group who had either reached 24 months of postoperative follow-up or were deemed early clinical failures were included in the primary outcome analysis. The arthroplasty group had a higher proportion of patients who achieved composite clinical success than did the fusion group (73.5% versus 25.5%; p < 0.001), equating to a between-group difference of 47.9% (95% confidence interval, 33.0% to 62.8%). The arthroplasty group outperformed the fusion group in most patient-reported outcome measures (including the ODI, VAS back pain, and all ZCQ component scores) at 24 months postoperatively. There were no significant differences between groups in surgical variables or complications, except that the fusion group had a higher rate of developing symptomatic adjacent segment degeneration., Conclusions: Among patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis, lumbar facet arthroplasty was associated with a higher rate of composite clinical success than fusion was at 24 months postoperatively., Level of Evidence: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence., Competing Interests: Disclosure: This study was funded by Premia Spine (the manufacturer of the device being studied), which funded third-party data management and statistical analysis as well as the study coordinators at the study sites. The Article Processing Charge for open access publication was funded by Premia Spine. The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article ( http://links.lww.com/JBJS/H984 )., (Copyright © 2024 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated.)

Study Design: Prospective randomized Food and Drug Administration investigational device exemption clinical trial., Objective: The purpose of the present study is to report the 1-year clinical and radiographic outcomes and safety profile of patients who underwent lumbar facet arthroplasty through implantation of the Total Posterior Spine System (TOPS) device., Summary of Background Data: Lumbar facet arthroplasty is one proposed method of dynamic stabilization to treat grade-1 spondylolisthesis with stenosis; however, there are currently no Food and Drug Administration-approved devices for facet arthroplasty., Methods: Standard demographic information was collected for each patient. Radiographic parameters and patient-reported outcome measures were assessed preoperatively and at regular postoperative intervals. Complication and reoperation data were also collected for each patient., Results: At the time of this study, 153 patients had undergone implantation of the TOPS device. The mean surgical time was 187.8 minutes and the mean estimated blood loss was 205.7cc. The mean length of hospital stay was 3.0 days. Mean Oswestry Disability Index, Visual Analog Score leg and back, and Zurich Claudication Questionnaire scores improved significantly at all postoperative time points ( P >0.001). There were no clinically significant changes in radiographic parameters, and all operative segments remained mobile at 1-year follow-up. Postoperative complications occurred in 11 patients out of the 153 patients (7.2%) who underwent implantation of the TOPS device. Nine patients (5.9%) underwent a total of 13 reoperations, 1 (0.6%) of which was for device-related failure owing to bilateral L5 pedicle screw loosening., Conclusions: Lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement in all patient-reported outcome measures and the ability to maintain motion at the index level while limiting sagittal translation with a low complication rate., Competing Interests: The authors declare no conflict of interest., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objective: The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial., Methods: The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory., Results: A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4-5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85°) to 24 months (3.86°)., Conclusions: This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.

Background: The goal of this study was to identify predictors of prolonged operative time (OT) in patients receiving posterior/transforaminal lumbar interbody fusion (P/TLIF) and examine the relationship between prolonged OT and perioperative outcomes in this population., Methods: The American College of Surgeons National Surgical Quality Improvement Program database was queried for patients undergoing single-level P/TLIF (Common Procedural Terminology code) between 2012 and 2018. Multivariable linear regression models were constructed to identify factors independently associated with changes in OT and examine the relationship between prolonged OT and perioperative outcomes (overall complications, surgical complications, medical complications, 30-day readmission, 30-day reoperation, and length of stay). All models were adjusted for sociodemographic variables, comorbidities, and procedure-specific variables., Results: Our cohort included 6260 patients. After adjusting for baseline covariates, age between 19 and 39 years increased OT by 15.14 minutes, male sex increased OT by 12.91 minutes, African American race increased OT by 17.82 minutes, other race increased OT by 18.13 minutes, obesity class III increased OT by 27.80 minutes, and the use of navigation increased OT by 10.83 minutes. Our multivariate logistic regression also found that after 2 hours, each additional hour of OT was associated with an increased risk of any complication (3-3.99 hours, odds ratio [OR], 1.68; 4-4.99 hours, OR, 2.33; and >5 hours, OR, 4.65). Incremental increases in OT were also associated with an increased risk of extended length of stay, readmission, and return to the operating room., Conclusions: The results of this study highlight several factors associated with prolonged OT and underscore its association with poorer perioperative outcomes. These data can be used to risk stratify patients before single-level P/TLIF., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background Context: Lumbar fusion is an effective and durable treatment for symptomatic lumbar spondylolisthesis; however, the current literature provides insufficient evidence to recommend an optimal surgical fusion strategy., Purpose: The present study aims to compare the clinical outcomes, fusion rates, blood loss, and operative times between open posterolateral lumbar fusion (PLF) alone and open transforaminal lumbar interbody fusion (TLIF) + posterolateral fusion for spondylolisthesis., Study Design: This is a systematic literature review and meta-analysis of English language studies for the treatment of spondylolisthesis with PLF versus PLF + TLIF., Patient Sample: Data were obtained from published randomized controlled trials (RCTs) and retrospective cohort studies., Outcome Measures: Clinical outcomes included Oswestry Disability Index (ODI), back pain, leg pain, and health-related quality of life (HRQOL) scores. Fusion rate, operative time, blood loss, and infection rate were also assessed., Methods: A literature search of three electronic databases was performed to identify investigations performed comparing PLF alone with PLF + TLIF for treatment of low-grade lumbar spondylolisthesis. The summary effect size was assessed from pooling observational studies for each of the outcome variables, with odds ratios (ORs) used for fusion and infection rate, mean difference used for improvement in ODI and leg pain as well as operative time and blood loss, and standardized mean difference used for improvement in back pain and HRQOL outcomes. Studies were weighed based on the inverse of the variance and heterogeneity. Heterogeneity was assessed using the I 2 -an estimate of the error caused by between-study variation. Effect sizes from the meta-analysis were then compared with data from the RCTs to assess congruence in outcomes., Results: The initial literature search yielded 282 unique, English language studies. Seven were determined to meet our inclusion criteria and were included in our qualitative analysis. Five observational studies were included in our quantitative meta-analysis. The pooled fusion success rates were 84.7% (100/118) in the PLF group and 94.3% (116/123) in the TLIF group. Compared with TLIF patients, PLF patients had significantly lower odds of achieving solid arthrodesis (OR 0.33, 95% confidence interval [CI] 0.13-0.82, p=.02; I 2 =0%). With regard to improvement in back pain, the point estimate for the effect size was -0.27 (95% CI -0.43 to -0.10, p=.002; I 2 =0%), in favor of the TLIF group. For ODI, the pooled estimate for the effect size was -3.73 (95% CI -7.09 to -0.38, p=.03; I 2 =35%), significantly in favor of the TLIF group. Operative times were significantly shorter in the PLF group, with a summary effect size of -25.55 (95% CI -43.64 to -7.45, p<.01; I 2 =54%). No significant difference was observed in leg pain, HRQOL improvement, blood loss, or infection rate. Our meta-analysis results were consistent with RCTs, in favor of TLIF for achieving radiographic fusion and greater improvement in ODI and back pain., Conclusions: Our results demonstrate that for patients undergoing fusion for spondylolisthesis, TLIF is superior to PLF with regard to achieving radiographic fusion. However, current data only provide weak support, if any, favoring TLIF over PLF for clinical improvement in disability and back pain., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background Context: Transforaminal lumbar interbody fusion (TLIF) or anterior lumbar interbody fusion with percutaneous pedicle screws (ALIFPS) offer significantly higher radiographic fusion rates than other fusion techniques for L5-S1 isthmic spondylolisthesis (IS). As it stands, there is a relative paucity of comparative data of the two techniques., Purpose: To define the clinical, radiographic, and financial differences between TLIF and ALIFPS for L5-S1 IS., Design/setting: A retrospective cohort study conducted at a single tertiary care center., Patient Sample: Sixty-six patients who underwent either TLIF or ALIPFS for L5-S1 IS at a single tertiary care center between 2009 and 2014., Outcome Measures: Quality of life outcome scores including the EuroQol-5 Dimensions (EQ-5D), Pain Disability Questionnaire (PDQ), and Patient Health Questionnaire-9 (PHQ-9). Sagittal balance parameters including: pelvic incidence, pelvic tilt, sacral slope, segmental lordosis, total lordosis, degree of slip, disc height, and L1-axis S1 distance (LASD). Cost measures included in-hospital charges, hospital length of stay (LOS), and post-admission costs accrued over 1 year., Methods: Quality of life (QoL) outcome scores, radiographic data, and financial data were collected with a minimum of 1-year follow-up. Clinical results were investigated using the PDQ, PHQ-9, and EQ-5D. Radiographic measurements included lumbar lordosis, segmental lordosis, pelvic tilt, pelvic incidence, height of disc, L-1 axis S-1 distance, and the degree of slip. Cost data were generated based on patient-level resource utilization. Comparative data were presented as median with interquartile range (IQR). Continuous variables were compared using either independent Student t tests assuming unequal variance or Mann-Whitney U tests for parametric and nonparametric variables, respectively. The minimally clinical important difference (MCID) used for each questionnaire was as follows: PDQ (26), PHQ-9 (5), and EQ-5D (0.4)., Results: A total of 66 patients met inclusion criteria. In the ALIFPS cohort, PDQ scores improved from 69 [47, 82] to 26 [18.2, 79.7], p=.02. In the TLIF cohort, PDQ scores improved from 73 [46, 85] to 48.5 [23, 67.5], p=.01. Both groups also showed a significant improvement in EQ-5D scores at 1 year, but the ALIFPS group showed a significantly greater improvement in EQ-5D scores at 1 year (0.1 [0,0.2] vs. 0.2 [0.1, 0.4], p=.02). Furthermore, only the ALIFPS cohort showed a significant improvement in segmental lordosis. The ALIFPS cohort showed a significantly greater improvement in disc height than did TLIF (3.5 [2, 5.5] vs. 6.7 [4.1, 10], p=.01). No significant differences were found in the direct costs of both procedures., Conclusions: Our findings suggest that anterior lumbar interbody fusion with percutaneous pedicle screws can achieve better clinical outcomes compared with TLIF for the treatment of IS. We believe the superior radiographic outcomes achieved through ALIFPS, namely a greater restoration of segmental lordosis and disc height, may have contributed to the improved clinical outcomes presented in the current study., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: There are a multitude of treatments for low-grade lumbar spondylolisthesis. There are no clear guidelines for the optimal approach., Objective: To identify the surgical treatment patterns for spondylolisthesis among United States spine surgeons., Methods: 445 spine surgeons in the United States completed a survey of clinical/radiographic case scenarios on patients with lumbar spondylolisthesis with neurogenic claudication with (S+BP) or without (S-BP) associated mechanical back pain. Treatment options included decompression, laminectomy with posterolateral fusion, posterior lumbar interbody fusion, or none of the above. The primary outcome measure was the probability of 2 randomly chosen surgeons disagreeing on the treatment method., Results: There was 64% disagreement (36% agreement) among surgeons for treatment of spondylolisthesis with mechanical back pain (S+BP) and 71% disagreement (29% agreement) for spondylolisthesis without mechanical back pain (S-BP). For S+BP, disagreement was 52% for those practicing 5 to 10 years versus 70% among those practicing more than 20 years. Orthopedic surgeons had greater disagreement than did neurosurgeons (76% vs. 56%) for S+BP. Greater clinical equipoise was seen for S-BP than for S+BP regardless of surgeon characteristics. For spondylolisthesis without mechanical back pain, neurosurgeons were significantly more likely to select decompression-only than were orthopedic surgeons, who more commonly selected fusion., Conclusions: Clinical equipoise exists for the treatment of spondylolisthesis. Differences are greater when the patient presents without associated back pain. Surgeon case volume, practice duration, and specialty training influence operative decisions for a given pathologic condition. Recognizing this practice variation will hopefully lead to better evidence and practice guidelines for the optimal and most cost-effective treatment paradigms., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Study Design: A retrospective cohort study., Objective: The objective of this study is to compare the radiographic and clinical outcomes of transforaminal lumbar interbody fusion (TLIF) with bilateral facetectomy (BF) versus unilateral facetectomy (UF)., Summary of Background Data: BF is a surgical technique utilized with the intent of creating a greater degree of segmental lordosis than UF alone. However, the clinical benefits of this technique have not been defined. We seek to determine whether a difference exists between bilateral versus UF during TLIF by utilizing both clinical and radiographic outcome measures., Methods: The electronic medical records of 57 patients who underwent single-level TLIF with either a UF (n = 28) or BF (n = 29) were reviewed. Clinical outcomes were measured through Patient Health Questionnaire-9 (PHQ-9), Pain Disability Questionnaire (PDQ), EuroQol 5 Dimensions (EQ-5D) Health State, and Quality Adjusted Life Year (QALY). Radiographic parameters including disc height and sagittal balance were measured on plain radiographs at 1 year following operation., Results: All radiographic parameters showed no significant differences between the UF and BF cohorts. Segmental lordosis increased significantly in both cohorts. However, there was no significant difference in the increase of segmental lordosis between cohorts. Overall lumbar lordosis did not increase significantly in either cohort. Perioperative complications were also similar between cohorts. PDQ and EQ-5D scores improved significantly in both cohorts at 1 year postoperatively. The BF cohort showed a significantly greater improvement in both EQ-5D (0.1 ± 0.2 vs. 0.3 ± 0.2, P = 0.01) and PHQ-9 scores (-0.8 ± 4.6 vs. 4.6 ± 5.2, P = 0.03) than the UF cohort. The PDQ score improved over the minimally clinical important difference (MCID) of 26 in only the BF cohort., Conclusion: The findings in the present study demonstrate that BF during single-level TLIF improves clinical outcomes to a greater degree than UF without any notable differences in perioperative complications or radiographic measurements., Level of Evidence: 3.

Objective: Interbody lumbar fusion techniques have become increasingly popular because of improved rates of fusion, restoration of disc and foraminal height, and promotion of lordosis. Morbidity has been associated with the exposure for these fusions, potentially leading to muscle injury, trunk muscle weakness, and pain. Minimal access surgery has been advocated to limit the exposure related morbidity. Tubular retractors are available, which allow dilation of the muscle through a small incision. The downside of these dilators is the expense required to use them and a generally cumbersome design, which can limit mobility and medial/lateral exposure., Methods: The authors report their experience with a standard ventral cervical retractor system for minimal access transforaminal lumbar interbody fusion. These systems are already owned by the hospital and are familiar to most spine surgeons., Results: The system is placed through a fascial plane between muscles, eliminating muscle dissection and limiting undue retraction and tissue destruction., Conclusion: A standard ventral cervical retractor may be used to perform minimal access transforaminal lumbar interbody fusion. The exposure is as good as or better than tubular retractor systems commercially available. There may be considerable cost savings owing to the elimination of the need for yet another specialized piece of equipment in the operating room. Time may also be saved, as spine surgeons are already adept in the use of such retractors.

Background Context: Multiple studies have determined minimum clinically important difference (MCID) thresholds for EuroQOL-5 Dimensions (EQ-5D) scores in lumbar fusion patients. However, a comprehensive understanding of predictors for a clinically significant improvement (CSI) postoperatively does not exist.Purpose: To determine medical, radiographic, and surgical predictors for obtaining a CSI following lumbar fusion surgery.Study Design: This is a retrospective review of patients who underwent instrumented lumbar fusion.Patient Sample: We included patients who underwent lumbar fusion for any indication between 2008 and 2013.Outcome Measures: Outcome measures included preoperative and postoperative EQ-5D Index scores.Materials and Methods: The medical records of patients who received a lumbar fusion for any indication were retrospectively reviewed to identify patient medical and surgical characteristics. A blinded reviewer assessed radiographs for each patient to examine sagittal alignment following fusion. Multivariable logistic regression was used to model the achievement of a CSI based on two commonly cited MCID values.Results: A total of 231 patients fit the inclusion criteria; 58% exceeded an MCID value for an EQ-5D score of 0.100, and 16% exceeded an MCID value of 0.390. Statistically significant independent predictors of not obtaining a CSI for an MCID threshold of 0.100 included a higher preoperative EQ-5D score (odds ratio [OR]=44.8) and L5-S1 fusion (OR=3.3). For an MCID value of 0.390, a higher preoperative EQ-5D score (OR=2,080.8) and a diagnosis of depression (OR=7.1) were predictive of not achieving a CSI, whereas spondylolisthesis (OR=4.1) was predictive of obtaining a CSI postoperatively. For both MCID values, patients who achieved a CSI had better postoperative quality of life (QOL) scores for all metrics measured, despite worse QOL scores preoperatively.Conclusions: This study is the first to use a combination of medical, surgical, and postoperative sagittal balance variables as determinants for the achievement of a CSI after lumbar fusion. The awareness of these predictors may allow for better patient selection and surgical approach to decrease the probability of acquiring a poor outcome postoperatively. [ABSTRACT FROM AUTHOR]

Recent published RCTs have created uncertainty around the appropriate utilization of lumbar fusion when performing a laminectomy for symptomatic lumbar degenerative spondylolisthesis. SLIP II is an RCT that aims to determine if spinal expert review might help to optimize patient experience and outcome for patients with degenerative lumbar spondylolisthesis. To determine if use of a surgical expert review panel might improve surgical outcome for patients with symptomatic degenerative lumbar spondylolisthesis. Multicenter prospective RCT at 14 sites. A total of 273 patients with Grade I degenerative lumbar spondylolisthesis enrolled in an RCT (SLIP II) and with 1-year follow-up. EuroQol 5-D Owestery Disability Index NASS patient satisfaction index We performed a multicenter prospective RCT at 14 sites. Patients (ages 18-85) with symptomatic lumbar stenosis with degenerative spondylolisthesis were enrolled. Patients were randomized to either receive an expert panel review of their case or not. Spinal expert review consisted of 10-15 surgeons' review of patient imagines and history regarding appropriateness of fusion that was shared with both treating surgeon and patient. Patients had surgical treatment at the discretion of the treating surgeon. Analysis focused upon whether outcomes differed when surgery aligned with the majority of the panel experts or not. Analysis also focused on whether super majority consensus on treatment was associated with superior outcomes or not. Outcome assessments (EQ-5D and ODI) were assessed preoperatively, 3 months, 6 months, and 1 year. NASS patient satisfaction was also assessed at 1 year. Fourteen sites randomized 575 patients. Analysis was performed on 273 patients who had one-year follow-up available. Of these, 146 underwent review and 127 no review. Mean age was 66 years (57% female). Baseline characteristics were comparable. Fusion was performed on 210 (77%) of patients. For patients randomized to an expert review – fusion was recommended in 112/146 (77%) cases. Fusion was associated with significantly improved outcomes regardless of panel recommendation. ODI and EQ-5D outcomes for patients treated with decompression alone versus decompression and fusion were not different at one-year; ODI (20-point change vs 22-point change, respectively [p=0.594]) and EQ-5D (0.25 change vs 0.23 change, respectively [p=0.799]). A super majority (>80% consensus among experts) recommended fusion 54% of the time and decompression alone 15% of the time. Super majority recommendation for fusion aligned with actual surgery performed in 92% of cases. NASS patient satisfaction was graded at 1 (treatment met my expectations) in 83% of patients who had super majority review favoring fusion as compared to 65% of other cases (P=0.12). Supermajority recommendation for fusion was associated with 24.7-point ODI change vs 17.3-point ODI change (p= 0.024) and 0.28 change in Eq5D vs 0.19 change in Eq5D (p=0.026). Expert panel review does not reduce the number of fusion operations performed but is associated with a trend toward improved patient satisfaction at one year after surgery. Super majority vote for fusion was associated with superior patient reported outcomes. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

The purpose of the present study is to report the 1-year clinical and radiographic outcomes as well as safety profiles of patients who underwent lumbar facet arthroplasty via implantation of the TOPS device as part of a prospective Investigational Device Exemption (IDE) trial. Prospective FDA IDE trial. We reviewed the prospectively collected clinical and radiographic outcomes of patients who underwent facet arthroplasty via implantation of the TOPS device in the investigational arm of a multicenter, prospective, randomized, controlled FDA IDE trial. Standard demographic information was collected for each patient, including surgical variables. Radiographic parameters and patient reported outcome measures (PROMs) including ODI, VAS back and leg, and ZCQ were assessed preoperatively and at 6 weeks, 3 months, 6 months, and 12 months postoperatively. Adverse event, complication and reoperation data were also collected for each patient. At the time of this study, 153 patients had undergone implantation of the TOPS device as part of this ongoing clinical trial and were included in this study. The mean surgical time was 187.8 minutes and mean estimated blood loss was 205.7cc. The mean length of hospital stay was 3.0 days. Mean ODI, VAS leg and back, and ZCQ scores improved significantly at all postoperative time points (P>0.001). Greater than 79% of patients achieved MCID in all patient reported outcome measures at all postoperative time points. There were no clinically significant changes in radiographic parameters and all operative segments remained mobile at 1-year follow-up without evidence of worsening sagittal translation. Postoperative complications occurred in 11 patients out of the 153 patients (7.2%) who underwent implantation of the TOPS device, including two new neurological deficits, two dural tears, two retained drains, one misplaced pedicle screw, one screw loosening, one infection, one seroma and one hematoma. Nine patients (5.9%) underwent a total of 13 reoperations, eight for surgical complications (5.3%) and one (0.6%) of which was for device-related failure due to bilateral L4 pedicle screw loosening. Lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement in all PROMs and the ability to maintain motion at the index level while limiting sagittal translation with a low complication rate. Total Posterior Spine System (TOPS) device: Investigational. [ABSTRACT FROM AUTHOR]