Treatment Of Degenerative Spondylolisthesis Research Articles

406 Long-term Outcomes of Lumbar Facet Arthroplasty versus Spinal Fusion in the Treatment of Degenerative Spondylolisthesis and Stenosis

INTRODUCTION: Facet arthroplasty is a proposed alternative to lumbar fusion for treating degenerative lumbar spondylolisthesis and stenosis. Facet arthroplasty provides stabilization and preserves range of motion. METHODS: Patient-reported outcomes (PROMS), including Oswestry disability index (ODI), visual analog pain scales (VAS), and Zurich claudication questionnaires (ZCQ), were assessed at baseline and at multiple timepoints postoperatively. Flexion/extension range of motion (ROM) were radiographically evaluated at baseline, 12 months, and 24 months. Data were analyzed following an intention-to-treat model. RESULTS: A total of 299 patients were included (TOPS = 206, TLIF = 93). There were no significant differences at baseline. At 2 years, the TOPS group had a significantly greater proportion of patients report =30% improvement for ODI (93.8% versus 74.3%, p = 0.004) and =20-point improvement for VAS back (84.4% versus 61.8%, p = 0.014). At 1 year, TOPS group had a significantly greater proportion of patients report clinically significant improvements in all ZCQ categories (91.6% versus 78.5%, p = 0.012). In patients <65 years, the TOPS group had significantly improved PROMS compared to TLIF at 2 years; however, these differences were not observed in patients =65 years old. The TOPS groups preserved significantly more ROM at 12 (2.8° 95% CI [1.87; 3.74], p < 0.0001) and 24 (2.99° 95% CI [1.82; 4.15], p < 0.0001) months postoperatively compared to TLIF. ROM was similarly preserved in patients aged <64 and =65. The rate of adverse events did not differ significantly between groups (65.2% TOPS versus 61.5% TLIF). CONCLUSIONS: Facet arthroplasty preserves significantly more ROM and leads to improved PROMS compared to TLIF, particularly in younger patients. In older patients, the procedure improved outcomes significantly from baseline.

ChatGPT versus NASS clinical guidelines for degenerative spondylolisthesis: a comparative analysis.

Clinical guidelines, developed in concordance with the literature, are often used to guide surgeons' clinical decision making. Recent advancements of large language models and artificial intelligence (AI) in the medical field come with exciting potential. OpenAI's generative AI model, known as ChatGPT, can quickly synthesize information and generate responses grounded in medical literature, which may prove to be a useful tool in clinical decision-making for spine care. The current literature has yet to investigate the ability of ChatGPT to assist clinical decision making with regard to degenerative spondylolisthesis. The study aimed to compare ChatGPT's concordance with the recommendations set forth by The North American Spine Society (NASS) Clinical Guideline for the Diagnosis and Treatment of Degenerative Spondylolisthesis and assess ChatGPT's accuracy within the context of the most recent literature. ChatGPT-3.5 and 4.0 was prompted with questions from the NASS Clinical Guideline for the Diagnosis and Treatment of Degenerative Spondylolisthesis and graded its recommendations as "concordant" or "nonconcordant" relative to those put forth by NASS. A response was considered "concordant" when ChatGPT generated a recommendation that accurately reproduced all major points made in the NASS recommendation. Any responses with a grading of "nonconcordant" were further stratified into two subcategories: "Insufficient" or "Over-conclusive," to provide further insight into grading rationale. Responses between GPT-3.5 and 4.0 were compared using Chi-squared tests. ChatGPT-3.5 answered 13 of NASS's 28 total clinical questions in concordance with NASS's guidelines (46.4%). Categorical breakdown is as follows: Definitions and Natural History (1/1, 100%), Diagnosis and Imaging (1/4, 25%), Outcome Measures for Medical Intervention and Surgical Treatment (0/1, 0%), Medical and Interventional Treatment (4/6, 66.7%), Surgical Treatment (7/14, 50%), and Value of Spine Care (0/2, 0%). When NASS indicated there was sufficient evidence to offer a clear recommendation, ChatGPT-3.5 generated a concordant response 66.7% of the time (6/9). However, ChatGPT-3.5's concordance dropped to 36.8% when asked clinical questions that NASS did not provide a clear recommendation on (7/19). A further breakdown of ChatGPT-3.5's nonconcordance with the guidelines revealed that a vast majority of its inaccurate recommendations were due to them being "over-conclusive" (12/15, 80%), rather than "insufficient" (3/15, 20%). ChatGPT-4.0 answered 19 (67.9%) of the 28 total questions in concordance with NASS guidelines (P = 0.177). When NASS indicated there was sufficient evidence to offer a clear recommendation, ChatGPT-4.0 generated a concordant response 66.7% of the time (6/9). ChatGPT-4.0's concordance held up at 68.4% when asked clinical questions that NASS did not provide a clear recommendation on (13/19, P = 0.104). This study sheds light on the duality of LLM applications within clinical settings: one of accuracy and utility in some contexts versus inaccuracy and risk in others. ChatGPT was concordant for most clinical questions NASS offered recommendations for. However, for questions NASS did not offer best practices, ChatGPT generated answers that were either too general or inconsistent with the literature, and even fabricated data/citations. Thus, clinicians should exercise extreme caution when attempting to consult ChatGPT for clinical recommendations, taking care to ensure its reliability within the context of recent literature.

A prospective study of lumbar facet arthroplasty in the treatment of degenerative spondylolisthesis and stenosis: cost-effective assessment from the Total Posterior Spine system (TOPSTM) IDE Study: 2-year model revision and sensitivity analyses based on 305 subjects

BACKGROUND CONTEXTA previous cost-effectiveness analysis published in 2022 found that the Total Posterior Spine (TOPSTM) system was dominant over transforaminal lumbar interbody fusion (TLIF). This analysis required updating to reflect a more complete dataset and pricing considerations. PURPOSETo evaluate the cost-effectiveness of TOPSTM system as compared with TLIF based on an updated and complete FDA investigational device exemption (IDE) data set. STUDY DESIGN/SETTINGCost-utility analysis of the TOPSTM system compared to TLIF. PATIENT SAMPLEA multicenter, FDA IDE, randomized control trial (RCT) investigated the efficacy of TOPSTM compared to TLIF with a current population of n=305 enrolled and n=168 with complete 2-year follow-up. OUTCOME MEASURESCost and quality adjusted life years (QALYs) were calculated to determine our primary outcome measure, the incremental cost-effectiveness ratio. Secondary outcome measures included: net monetary benefit as well at willingness-to-pay (WTP) thresholds. METHODSThe primary outcome of cost-effectiveness is determined by incremental cost-effectiveness ratio. A Markov model was used to simulate the health outcomes and costs of patients undergoing TOPSTM or TLIF over a 2-year period. alternative scenario sensitivity analysis, one-way sensitivity analysis, and probabilistic sensitivity analysis were conducted to assess the robustness of the model results. RESULTSThe updated base case result demonstrated that TOPSTM was immediately and longitudinally dominant compared with the control with an incremental cost-effectiveness ratio of −9,637.37 $/QALY. The net monetary benefit was correspondingly $2,237, both from the health system's perspective and at a WTP threshold of 50,000 $/QALY at the 2-year time point. This remained true in all scenarios tested. The Alternative Scenario Sensitivity Analysis suggested cost-effectiveness irrespective of payer type and surgical setting. To remain cost-effective, the cost difference between TOPSTM and TLIF should be no greater than $1,875 and $3,750 at WTP thresholds of $50,000 and 100,000 $/QALY, respectively. CONCLUSIONSThis updated analysis confirms that the TOPSTM device is a cost-effective and economically dominant surgical treatment option for patients with lumbar stenosis and degenerative spondylolisthesis compared to TLIF in all scenarios examined.

Comparing Posterior Lumbar Decompression and Fusion and Transforaminal Lumbar Interbody Fusion in Lumbar Degenerative Spondylolisthesis as Assessed by the CARDS Classification System

ObjectiveIn a retrospective cohort study, we compared the outcomes among clinical and radiographic degenerative spondylolisthesis (CARDS) subtypes for patients undergoing posterior lumbar decompression and fusion (PLDF) or transforaminal lumbar interbody fusion (TLIF) and evaluated the CARDS system as a tool to guide clinical decisions regarding the treatment of degenerative spondylolisthesis (DS). MethodsPatients undergoing PLDF or TLIF for DS from 2010 to 2020 were identified. The patients were grouped by the preoperative CARDS classification. Multivariate analysis was used to determine the effects of the treatment approach on the 1-year patient-reported outcome measures (PROMs) and 90-day surgical outcomes. ResultsA total of 1056 patients were included: 148 patients with type A DS, 323 with type B, 525 with type C, and 60 with type D. Patients with CARDS types A and C who underwent PLDF experienced a longer length of stay and were less likely to be discharged home. No differences were found in the incidence of revisions, complications, or readmissions between the surgical approaches. Patients with CARDS type A undergoing PLDF were less likely to achieve a minimal clinically important difference for back pain (36.8% vs. 76.7%; P = 0.013). No other significant differences were found in the PROMs among the CARDS subtypes. TLIF independently predicted for better leg pain improvement using the visual analog scale at 1 year of follow-up (β = −2.92; P = 0.017) for patients with CARDS type A. Multivariable analysis demonstrated no significant differences in PROMs by surgical approach among the other CARDS subtypes. ConclusionsPatients with disc space collapse and endplate apposition (CARDS type A) appear to benefit from TLIF. However, patients with lumbar spondylolisthesis without disc space collapse or kyphotic angulation (CARDS types B and C) showed no benefit from additional interbody placement.

Decompression alone versus decompression with fusion in patients with lumbar spinal stenosis with degenerative spondylolisthesis: a systematic review and meta-analysis.

Surgical decompression is standard care in the treatment of degenerative spondylolisthesis in patients with symptomaticlumbar spinal stenosis, but there remains controversy over the benefits of adding fusion. The persistent lack of consensus on this matter and the availability of new data warrants a contemporary systematic review and meta-analysis of the literature. Multiple online databases were systematically searched up to October 2022 for randomized controlled trials (RCTs) and prospective studies comparing outcomes of decompression alone versus decompression with fusion for lumbar spinal stenosis in patients with degenerative spondylolisthesis. Primary outcome was the Oswestry Disability Index. Secondary outcomes included leg and back pain, surgical outcomes, and radiological outcomes. Pooled effect estimates were calculated and presented as mean differences (MD) with their 95% confidence intervals (CI) at two-year follow-up. Of the identified 2403 studies, eventually five RCTs and two prospective studies were included. Overall, most studies had a low or unclear risk of selection bias and most studies were focused on low grade degenerative spondylolisthesis. All patient-reported outcomes showed low statistical heterogeneity. Overall, there was high-quality evidence suggesting no difference in functionality at two years of follow-up (MD - 0.31, 95% CI - 3.81 to 3.19). Furthermore, there was high-quality evidence of no difference in leg pain (MD - 1.79, 95% CI - 5.08 to 1.50) or back pain (MD - 2.54, 95% CI - 6.76 to 1.67) between patients undergoing decompression vs. decompression with fusion. Pooled surgical outcomes showed less blood loss after decompression only, shorter length of hospital stay, anda similar reoperation ratecompared to decompression with fusion. Based on the current literature, there is high-quality evidence of no difference in functionality after decompression alone compared to decompression with fusion in patients with degenerative lumbar spondylolisthesis at 2years of follow-up. Further studies should focus on long-term comparative outcomes, health economic evaluations, and identifying those patients that may benefit more from decompression with fusion instead of decompression alone. This review was registered at Prospero (CRD42021291603).

210. Patient-reported and clinical outcomes after lumbar laminectomy and fusion versus laminectomy alone in patients with lumbar spondylolisthesis and harmonious sagittal spinopelvic alignment

<h3>BACKGROUND CONTEXT</h3> The treatment of degenerative spondylolisthesis with decompression alone remains controversial. However, it is well known that all degenerative spondylolistheses are not created equally. As such, one must compare equivalent pathology to better assess treatment options. <h3>PURPOSE</h3> This study assessed 2-year clinical outcomes following laminectomy plus fusion versus laminectomy alone for management of Grade I degenerative spondylolisthesis and comorbid spinal canal stenosis among patients with sagittal spinopelvic alignment (pelvic incidence - lumbar lordosis <10°). <h3>STUDY DESIGN/SETTING</h3> Subgroup analysis of observational prospective cohort study. <h3>PATIENT SAMPLE</h3> A total of 679 patients treated with laminectomy with fusion or laminectomy alone for Grade I degenerative spondylolisthesis and comorbid spinal stenosis at a tertiary care center. <h3>OUTCOME MEASURES</h3> Outcome measures comprised estimated blood loss, operative time, length of hospital stay, discharge to skilled nursing facility, prospective patient-reported outcomes (PROs) and reoperation. <h3>METHODS</h3> Cohorts were matched based on degree of lumbar spondylolisthesis, flexion-extension listhesis and intervertebral disc height. Two alternative matching methods were employed to minimize treatment selection bias when estimating treatment effects: (1) propensity score matching (PSM) and (2) coarsened exact matching (CEM). Binary outcomes between cohorts were evaluated using McNemar test; continuous outcomes used the Wilcoxon rank-sum test. <h3>RESULTS</h3> A total of 327 (48.1%) study patients had low PILL mismatches (< 10°), indicating good sagittal spinopelvic alignment. After PSM and CEM matching to control treatment choice bias, patients undergoing fusion experienced greater operative blood loss (203 vs 125 mL, p=0.0006), operative time (216 vs 128 min, p=0.0006), and length of stay (3.50 vs 2.83 days, p < 0.0001) than patients receiving decompression alone; in turn, these patients were more likely to be discharged to rehabilitation facilities (6.86% vs 0.98%, p=0.0412) and receive longer durations of physical therapy postoperatively (2.47 vs 1.34 months, p<0.0001). Finally, fusion-treated patients had a greater likelihood of reoperation at 2 years (25.49% vs 14.71%, p=0.0152). CEM matching generally did not alter the pattern, significance or direction of findings. <h3>CONCLUSIONS</h3> Lumbar laminectomy was superior to fusion in health-related quality of life and reoperation rate at 2 years postoperatively for patients without PILL mismatch. Patients with low-grade spondylolisthesis, spinal stenosis, and spinopelvic harmony may benefit from less invasive decompression alone. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

90. Decision-making factors leading to fusion vs decompression for one-level degenerative spondylolisthesis: survey results from members of the Lumbar Spine Research Society and Society of Minimally Invasive Spine Surgery

<h3>BACKGROUND CONTEXT</h3> Degenerative spondylolisthesis is one of the most common pathologies spine surgeons treat. While a number of potential factors have been identified, there is no current consensus on which variables most impact the decision to fuse vs decompress alone in this population. <h3>PURPOSE</h3> The aim of this study was to identify radiographic and clinical factors leading to the decision to fuse segments for one-level degenerative spondylolisthesis. <h3>STUDY DESIGN/SETTING</h3> We performed a descriptive cross-sectional study utilizing a survey consisting of questions pertaining to decision-making factors leading to fusion or decompression alone in the setting of degenerative spondylolisthesis. <h3>OUTCOME MEASURES</h3> Radiographic parameters included grade of spondylolisthesis, instability, facet orientation >60°, facet diastasis, laterolisthesis or scoliosis, synovial cysts, vacuum disc, vertical disc space, preserved disc height, concomitant herniated nucleus pulposus, and symptomatic foraminal stenosis. Clinical factors included age >70 years, activity level, patient sex, body mass index >35, osteoporosis, primary complaint of low back pain, primary complaint of neurogenic claudication, smoking, and anxiety/depression. <h3>METHODS</h3> A survey was administered to the Lumbar Spine Research Society and Society of Minimally Invasive Spine Surgery. The primary analysis was limited to completed surveys. Baseline characteristics were summarized. Clinical and radiographic parameters were ranked and compared using chi-square, Fisher's exact test, Kruskal-Wallis, or two-sample t-test as appropriate. <h3>RESULTS</h3> A total of 381 (67.9%) surveys were returned completed. Respondents' mean years in practice was 17.8 ± 9.4 years and 296 (77.7%) had undergone a formal spine fellowship. The majority of respondents were from the US (45.9%) followed by Europe (24.1%), and Asia/Pacific (17.1%). The practice setting included academics (32.5%), private practice (31.0%), hospital-employed (17.1%), or a combination (19.4%). The mean number of degenerative spondylolisthesis cases performed was 53.8 ± 46.7 cases per year with 49.9% of the cohort performing these cases utilizing minimally invasive techniques. With regard to fusion vs decompression: 19.9% fuse all cases, 39.1% fuse >75%, 17.8% fuse 50%-75%, and 23.2% fuse <25%. The most common decompressive technique was a partial laminotomy (51.4%), followed by full laminectomy (28.9%). Among respondents, 82.2% instrument all fusion cases. Instability (93.2%), spondylolisthesis grade (59.8%) and laterolisthesis (37.3%) were the most common radiographic factors impacting the decision to fuse. Instability did not fall below the sixth rank with 75% of surgeons ranking it as the most important parameter. The top parameters also included spondylolisthesis grade, laterolisthesis, facet diastasis, and symptomatic foraminal stenosis. With regard to the clinical factors leading to fusion, mechanical low back pain (83.2%), activity level (58.3%) and neurogenic claudication (42.8%) were the top three clinical parameters. When ranked, the top parameters were mechanical low back pain, activity level, neurogenic claudication, bone mineral density and anxiety/depression. <h3>CONCLUSIONS</h3> There is little consensus on the treatment of degenerative spondylolisthesis, with society members showing substantial variation in treatment patterns. The most common radiographic parameters impacting treatment are instability, spondylolisthesis grade, and laterolisthesis while mechanical low back pain, activity level and neurogenic claudication are the most common clinical parameters. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

128. A prospective study of lumbar facet arthroplasty in the treatment of degenerative spondylolisthesis and stenosis: results from the Total Posterior Spine System (TOPS) IDE study

<h3>PURPOSE</h3> 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. <h3>STUDY DESIGN/SETTING</h3> Prospective FDA IDE trial. <h3>METHODS</h3> 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. <h3>RESULTS</h3> 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. <h3>CONCLUSIONS</h3> 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. <h3>FDA DEVICE/DRUG STATUS</h3> Total Posterior Spine System (TOPS) device: Investigational.

P124. Does simultaneous decompression above a fusion lead to progressive adjacent segment disease requiring revision surgery?

<h3>BACKGROUND CONTEXT</h3> Degenerative spondylolisthesis (DS) is a condition that often requires surgical treatment. This treatment varies based on surgeon preference and the extent of lumbar pathology seen on imaging. There is controversy regarding the surgical management of segments adjacent to the level of DS that require decompression. While it is understood that decompression and fusion of affected levels is necessary, it is unclear how best to treat levels adjacent to the level of DS. Some surgeons will always fuse any additional levels that require decompression while others will decompress adjacent segments without extending the fusion. Each technique has its own theoretical risks, but analysis of adjacent segment disease (ASD) and need for repeat surgery has not been extensively studied. <h3>PURPOSE</h3> The primary aim is to identify the rate of and risk factors related to progression of ASD and the need for revision surgery in patients with surgically treated DS. The secondary aim is to analyze the efficacy of decompressing adjacent levels without fusion. <h3>STUDY DESIGN/SETTING</h3> All patients treated surgically for DS at a tertiary care medical center over a 5-year period were retrospectively reviewed. Patients were divided into two cohorts consisting of those patients who were fused at all decompressed levels versus those who were not fused at all decompressed levels. <h3>PATIENT SAMPLE</h3> Adult patients who had decompression and fusion of affected levels with decompression of adjacent levels and at least 1 year of followup were included. There were 137 such patients identified. <h3>OUTCOME MEASURES</h3> Patient demographics, level(s) of DS at presentation, ASD rates and reoperation rates were measured and analyzed. Rates of ASD were measured based on clinical presentation, radiographic results and/or need for reoperation. <h3>METHODS</h3> Descriptive statistics were used to summarize demographic and comorbidity data. Relative risks were calculated and two proportion z-test was used to compare rates of adverse events in the two surgical cohorts. Odds ratios were calculated for risk factors associated with adverse events. <h3>RESULTS</h3> Of the 137 patients, 86 (63%) were female and 51 (37%) were male. The average followup was 19.9 months. There were 119 (87%) patients with single level DS and 18 (13%) with DS at two adjacent levels. The most common level for DS was L4-5 (100, 73%). Thirty-four patients underwent a multilevel decompression and fusion only at the level of the DS, while 103 had a fusion at all the decompressed levels. Twelve patients (9%) had progression of ASD requiring extension of their construct; 11 of these patients were female (92%), however female sex was not a statistically significant risk factor for ASD (p = 0.06). Of the 12 patients, 3 had DS at L3-4, 9 at L4-5 and 2 at L5-S1. Two patients were decompressed more levels than fused, and 10 were fused at all levels decompressed. Neither level of DS nor surgical technique correlated with increased risk of ASD. <h3>CONCLUSIONS</h3> Progression of ASD requiring revision surgery is a risk after surgery for DS. The data demonstrates that there is no additional risk of ASD if adjacent levels are decompressed without fusion. This is the first study to our knowledge that shows equal efficacy of decompression without fusion of adjacent levels for the treatment of lumbar DS. The researchers will next compare radiographic and patient-reported outcome data between patients treated with decompression of adjacent segments only versus those treated with decompression and fusion of adjacent segments. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Results from the Total Posterior Spine System (TOPS) IDE Study.

Prospective randomized Food and Drug Administration investigational device exemption clinical trial. 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. 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. 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. 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. 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.

A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Early Cost-effective Assessment from the Total Posterior Spine System (TOPS™) IDE Study.

Background: Given the increased attention to functional improvement in spine surgery as it relates to motion preservation, activities of daily living, and cost, it is critical to fully understand the healthcare economic impact of new devices being tested in large FDA randomized controlled trials (RCT). The purpose of this analysis was to comprehensively evaluate the cost-effectiveness of the novel Total Posterior Spine (TOPS™) System investigational device compared with the trial control group, standard transforaminal lumbar interbody fusion (TLIF).Objective: To evaluate the cost-effectiveness of TOPS™ compared with TLIF.Methods: The study patient population was extracted from a multicenter RCT with current enrollment at n=121 with complete 1-year follow-up. The primary outcome was cost-effectiveness, expressed as the incremental cost-effectiveness ratio. Secondary outcomes were health-related utility, presented as quality-adjusted life-years (QALYs), and cost, calculated in US dollars. Analysis was conducted following Second Panel on Cost-Effectiveness Health and Medicine recommendations. The base case analysis utilized SF-36 survey data from the RCT. Both cost and QALY outcomes were discounted at a yearly rate of 3% to reflect their present value. A cohort Markov model was constructed to analyze perioperative and postoperative costs and QALYs for both TOPS™ and control groups. Scenario, probabilistic, and threshold sensitivity analyses were conducted to determine model discrimination and calibration.Results: The primary time horizon used to estimate cost and health utility was 2 years after index surgery. From a health system perspective, assuming a 50/50 split between Medicare and private payers, the TOPS™ cohort is cost-effective 2 years postoperatively ($6158/QALY) compared with control. At 6 years and beyond, TOPS™ becomes dominant, irrespective of payer mix and surgical setting. At willingness-to-pay thresholds of $100 000/QALY, 63% of all 5000 input parameter simulations favor TOPS, even with a $4000 upcharge vs TLIF.Discussion: The novel TOPS™ device is cost-effective compared with TLIF and becomes the dominant economic strategy over time.Conclusions: In the emerging, rapidly expanding field of value-based medicine, there will be an increased demand for these analyses, ensuring surgeons are empowered to make the best, most sustainable solutions for their patients and society.

A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Early Cost-effective Assessment from the Total Posterior Spine System (TOPS™) IDE Study

Background: Given the increased attention to functional improvement in spine surgery as it relates to motion preservation, activities of daily living, and cost, it is critical to fully understand the healthcare economic impact of new devices being tested in large FDA randomized controlled trials (RCT). The purpose of this analysis was to comprehensively evaluate the cost-effectiveness of the novel Total Posterior Spine (TOPS™) System investigational device compared with the trial control group, standard transforaminal lumbar interbody fusion (TLIF). Objective: To evaluate the cost-effectiveness of TOPS™ compared with TLIF. Methods: The study patient population was extracted from a multicenter RCT with current enrollment at n=121 with complete 1-year follow-up. The primary outcome was cost-effectiveness, expressed as the incremental cost-effectiveness ratio. Secondary outcomes were health-related utility, presented as quality-adjusted life-years (QALYs), and cost, calculated in US dollars. Analysis was conducted following Second Panel on Cost-Effectiveness Health and Medicine recommendations. The base case analysis utilized SF-36 survey data from the RCT. Both cost and QALY outcomes were discounted at a yearly rate of 3% to reflect their present value. A cohort Markov model was constructed to analyze perioperative and postoperative costs and QALYs for both TOPS™ and control groups. Scenario, probabilistic, and threshold sensitivity analyses were conducted to determine model discrimination and calibration. Results: The primary time horizon used to estimate cost and health utility was 2 years after index surgery. From a health system perspective, assuming a 50/50 split between Medicare and private payers, the TOPS™ cohort is cost-effective 2 years postoperatively ($6158/QALY) compared with control. At 6 years and beyond, TOPS™ becomes dominant, irrespective of payer mix and surgical setting. At willingness-to-pay thresholds of $100 000/QALY, 63% of all 5000 input parameter simulations favor TOPS, even with a $4000 upcharge vs TLIF. Discussion: The novel TOPS™ device is cost-effective compared with TLIF and becomes the dominant economic strategy over time. Conclusions: In the emerging, rapidly expanding field of value-based medicine, there will be an increased demand for these analyses, ensuring surgeons are empowered to make the best, most sustainable solutions for their patients and society.

Comparison of degenerative lumbar spondylolisthesis and isthmic lumbar spondylolisthesis: effect of pedicle screw placement on proximal facet invasion in surgical treatment

BackgroundPedicle screw invasion of the proximal articular process will cause local articular process degeneration and acceleration, which is an important factor affecting adjacent segment degeneration. Although lumbar spondylolisthesis is a risk factor for screw invasion of the proximal joint, there is no clear conclusion regarding the two different types of spondylolisthesis. Therefore, the purpose of this study was to explore the influence of pedicle screw placement on proximal facet invasion in the treatment of degenerative spondylolisthesis and isthmic spondylolisthesis.MethodsIn total, 468 cases of lumbar spondylolisthesis treated by decompression and fusion in our hospital from January 2017 to January 2020 were included in this retrospective study. Among them, 238 cases were degenerative spondylolisthesis (group A), and 230 cases were isthmic spondylolisthesis (group B). Sex, age, body mass index, bone mineral density, preoperative visual analog scale (VAS) and Oswestry Disability Index (ODI) scores, postoperative VAS and ODI scores at 1 month and 3 months, and angle of the proximal facet joint at the last follow-up were recorded and compared between the two groups. The degree of pedicle screw invasion of the proximal facet joint was graded and compared by the SEO grading method.ResultsThere were no significant differences in sex, age, body mass index, bone mineral density, preoperative VAS and ODI scores, or proximal facet joint angle between the two groups (P > 0.05). There was no significant difference in VAS and ODI scores between the two groups at 1 month and 3 months after the operation (P > 0.05). The VAS score of group A at the last follow-up was 1 (1,2). The VAS score of group B at the last follow-up was 3 (1,3). The ODI score of group A at the last follow-up was 6(4,26). The ODI score of group B at the last follow-up was 15(8,36). The VAS and ODI scores of the two groups at the last follow-up were significantly different (P < 0.05). According to the SEO grading method, the invasion of the proximal articular process by pedicle screw placement in group A involved 320 cases in grade 0, 128 cases in grade I and 28 cases in grade II. In group B, there were 116 cases in grade 0, 248 cases in grade I and 96 cases in grade II, with a significant difference (P < 0.01).ConclusionIn summary, a certain number of cases involving screws invading the proximal facet joint occurred in the two different types of lumbar spondylolisthesis, but the number in the isthmic spondylolisthesis group was significantly higher than that in the degenerative spondylolisthesis group, which caused more trauma to the proximal facet joint and significantly affected the patient prognosis.

Management of degenerative spondylolisthesis: development of appropriate use criteria

Outcomes of treatment in care of patients with spinal disorders are directly related to patient selection and treatment indications. However, for many disorders, there is absence of consensus for precise indications. With the increasing emphasis on quality and value in spine care, it is essential that treatment recommendations and decisions are optimized. The purpose of the North American Spine Society Appropriate Use Criteria was to determine the appropriate (ie reasonable) multidisciplinary treatment recommendations for patients with degenerative spondylolisthesis across a spectrum of more common clinical scenarios. A Modified Delphi process was used. The methodology was based on the Appropriate Use Criteria development process established by the Research AND Development Corporation. The topic of degenerative spondylolisthesis was selected by the committee, key modifiers determined, and consensus reached on standard definitions. A literature search and evidence analysis were completed by one work group simultaneously as scenarios were written, reviewed, and finalized by another work group. A separate multidisciplinary rating group was assembled. Based on the literature, provider experience, and group discussion, each scenario was scored on a nine-point scale on two separate occasions, once without discussion and then a second time following discussion based on the initial responses. The median rating for each scenario was then used to determine if indications were rarely appropriate (1 - 3), uncertain (4-6), or appropriate (7-9). Consensus was not mandatory. There were 131 discrete scenarios. These addressed questions on bone grafting, imaging, mechanical instability, radiculopathy with or without neurological deficits, obesity, and yellow flags consisting of psychosocial and medical comorbidities. For most of these, appropriateness was established for physical therapy, injections, and various forms of surgical intervention. The diagnosis of spondylolisthesis should be determined by an upright x-ray. Scenarios pertaining to bone grafting suggested that patients should quit smoking prior to surgery, and that use of BMP should be reserved for patients who had risk factors for non-union. Across all clinical scenarios, physical therapy (PT) had an adjusted mean of 7.66, epidural steroid injections 5.76, and surgery 4.52. Physical therapy was appropriate in most scenarios, and most appropriate in patients with back pain and no neurological deficits. Epidural steroid injections were most appropriate in patients with radiculopathy. Surgery was generally more appropriate for patients with neurological deficits, higher disability scores, and dynamic spondylolisthesis. Mechanical back pain and presence of yellow flags tended to be less appropriate, and obesity in general had relatively little influence on decision making. Decompression alone was more strongly considered in the presence of static versus dynamic spondylolisthesis. On average, posterior fusion with or without interbody fusion was similarly appropriate, and generally more appropriate than stand-alone interbody fusion which was in turn more appropriate than interspinous spacers. Multidisciplinary appropriate treatment criteria were generated based on the Research AND Development methodology. While there were consistent and significant differences between surgeons and non-surgeons, these differences were generally very small. This document provides comprehensive evidence-based recommendations for evaluation and treatment of degenerative spondylolisthesis. The document in its entirety will be found on the North American Spine Society website (https://www.spine.org/Research-Clinical-Care/Quality-Improvement/Appropriate-Use-Criteria).

Role of Non-Rigid Minimal Intervention Surgery in the Treatment of Degenerative Spondylolisthesis

Introduction: Degenerative spondylolisthesis produces abnormal intervertebral movement associated with back pain. Standard surgical treatment consists of decompression with or without fusion. There is no consensus about the method of choice. Purpose of this study: avoiding decompression, a semi-rigid, minimally invasive device that reduces movement was used, removing the necessity for fusion and reducing fixation-loosening, or breakage. Methods: Analytical prospective observational study. The clinical assessment included the Oswestry Disability Index (ODI) and SF-12 (Short Form-12 Health Survey), X-Rays and MRIs (Magnetic Resonance Imaging) were taken preoperatively and at follow-up. Overall, the mean postoperative follow-up was 3.8 years. It is about a posterior intrapedicular device introduced percutaneously under X-Ray control. The device consists of two semi-rigid bars, allowing 5o multiplanar movement, and 1mm compressive-spring movement. Through manipulation and distraction, reduction of listhesis is possible, increasing disc and lateral recesses height. Results: At final follow-up, ODI and SF-12 scores significantly improved. ODI from 47.4 ± 14.9 to 22.8 ± 19.7 (p<0.001). In terms of SF-12, PHS (Physical Health Score) improved from 27.9 ± 6.3 to 37.5 ± 11.1 (p<0.001) and MHS (Mental Health Score) from 34.4 ± 11.3 to 42.7 ± 13.2 (p<0.002). The results give the message that despite generalized disc disease, a spondylolisthesis that moves is likely to be the symptomatic level. Reduction, increases spinal diameters, decompresses the neural elements and reduces movement sufficiently to stop movement-related pain. Conclusion: Semi-rigid percutaneous minimally invasive fixation is effective in the treatment of degenerative spondylolisthesis. Evident preoperative abnormal movement and reduction of the listhesis at operation are crucial factors. Due to minimal intervention and hence lack of access related injury no patient was made worse.

Current concepts in the treatment of degenerative spondylolisthesis

Degenerative spondylolisthesis is one of the commonest spinal pathologies encountered in the aging population. The clinical presentation of degenerative spondylolisthesis can be highly variable, and a large proportion of patients can be managed non-operatively. Operative treatment is reserved for patients with activity limiting disability. Decompression alone can be offered to patients with no radiological or clinical evidence of segmental instability. Fusion procedures have shown high rates of clinical success, although long-term effects such as adjacent segment degeneration have spurred the evolution of non-fusion technologies. These newer options have shown evidence of motion preservation, although long-term clinical benefits have yet to be confirmed.

Transforaminal lumbar interbody fusion in degenerative spondylolisthesis

Introduction Spinal fusion surgery is a common technique used to treat degenerative lumbar pathologies including disc herniation with instability, spinal stenosis, and degenerative spondylolisthesis (DS). Minimally invasive transforaminal lumbar interbody fusion (TLIF) is a common surgical procedure for treatment of DS. Aim We aimed to assess the outcomes of TLIF in DS. Patients and methods This study was conducted on 15 patients treated for DS treated with TLIF. A written informed consent was taken from all participants after proper explanation of the study. The study assessed perioperative results related to the operative procedure such as blood loss, operation time, hospital stay, and complications. Oswestry Disability Index (ODI) questionnaire was filled for functional evaluation, and the visual analog scale was used to assess pain preoperatively and postoperatively. Result A total of 15 cases were included. The mean age of the included cases was 53.67 years, the mean BMI was 26.73, 53.3% of cases were female, and 33.3% of patients were smokers. There was a significant decrease in visual analog scale ODI after operation. Regarding complications, 73.3% had no early complications but 13.3% had wound infection and 6.7% had positioning neuropathy and postoperative hematoma. Late complications were founded in 33.3% in the form of adjacent segment disease in 13.3%, arthrodesis in 13.3%, and fusion failure in 6.7%. Conclusion This study shows that TLIF is an effective procedure in surgical management of DS. The TLIF gives better results regarding reduction of low back pain and leg pain, as well as reduction in ODI score in early follow-ups and similar results in late follow-ups.

Canadian Spine SocietyPresentation CPSS1: Spinal insufficiency fracture in the geriatric pediatric spinePresentation CPSS2: The clinical significance of tether breakages in anterior vertebral body growth modulation: a 2-year postoperative analysisPresentation CPSS3: Anterior vertebral body growth modulation for idiopathic scoliosis: early, mid-term and late complicationsPresentation CPSS4: Ovine model of congenital chest wall and spine deformity with alterations of respiratory mechanics: follow-up from

Canadian Spine SocietyPresentation CPSS1: Spinal insufficiency fracture in the geriatric pediatric spinePresentation CPSS2: The clinical significance of tether breakages in anterior vertebral body growth modulation: a 2-year postoperative analysisPresentation CPSS3: Anterior vertebral body growth modulation for idiopathic scoliosis: early, mid-term and late complicationsPresentation CPSS4: Ovine model of congenital chest wall and spine deformity with alterations of respiratory mechanics: follow-up from

Comparison of Outcomes of Oblique Lateral Interbody Fusion with Percutaneous Posterior Fixation in Lateral Position and Minimally Invasive Transforaminal Lumbar Interbody Fusion for Degenerative Spondylolisthesis.

Study DesignSingle-center retrospective study.PurposeTo compare the physical function and quality of life (QOL) parameters of two minimally invasive surgical (MIS) procedures: oblique lateral interbody fusion with percutaneous posterior fixation in lateral position (OLIF-LPF) and minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) for single-level degenerative spondylolisthesis (DS). Overview of LiteratureTo date, many options for the surgical treatment of lumbar DS and reports have described the effectiveness of minimally invasive lateral access surgery and MIS-TLIF. However, there is still a paucity of comparative data regarding the physical function and QOL outcomes of OLIF and MIS-TLIF.MethodsEighty-six patients were enrolled in this study (group O: OLIF-LPF, n=38; group T: MIS-TLIF, n=48). We evaluated the operation time, estimated blood loss (EBL), postoperative laboratory data, preoperative and postoperative radiographic parameters, overall functional outcome with the Japanese Orthopedic Association Back Pain Evaluation Questionnaire (JOABPEQ) effectiveness rate, and Visual Analog Scale (VAS) score for low back pain, leg pain, and leg numbness.ResultsNo statistical differences in operation time, EBL, and C-reactive protein level, 5 days postoperatively, between groups O and T. With respect to radiological outcome, preoperative and postoperative disc height change was significantly greater in group O than in group T (3.8 vs. 1.8 mm, p<0.05). Both groups showed postoperative improvements in the clinical outcome scores of all JOABPEQ domains, but the effectiveness rate increase in the psychological domain was significantly higher in group O than in group T (47.1% vs. 14.6%, p<0.05). No differences in the preoperative and postoperative VAS score change were noted between the two groups in any of the items.ConclusionsThe changes in physical function and QOL parameters after OLIF-LPF and MIS-TLIF were almost equivalent; however, OLIF-LPF had significant superiority in the psychological domain.

Decompression alone for the treatment of degenerative lumbar spondylolisthesis

The purpose of this chapter is to present decompression surgery alone as a reasonable consideration in the treatment of degenerative spondylolisthesis with spinal stenosis. This procedure may be better than laminectomy and fusion in select patients. We review and highlight several clinical scenarios in which this might be the case. Recently published studies have advocated this treatment approach for particular patient profiles. Several surgical techniques and patient characteristics favorable for decompression alone are discussed.