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Background: Traditional surgical treatment for symptomatic cervical degenerative disc disease is anterior cervical discectomy and fusion (ACDF), yet the increased risk of adjacent segment degeneration (ASD) requiring additional surgery exists and may result in limiting long-term surgical success when it occurs. Disc arthroplasty can preserve or restore physiologic range of motion (ROM), decreasing adjacent level stress and subsequent surgery. For patients with multilevel pathology requiring at least a 1-level fusion, interest is growing in anterior cervical hybrid (ACH) surgery as a partial motion-preserving procedure to decrease the adjacent level burden. This radiographic study compares postoperative superior adjacent segment motion between ACH and ACDF. Secondarily, total global motion, construct motion, inferior adjacent segment motion, and sagittal alignment parameters were compared. Methods: This is a single-center, multi-surgeon, retrospective cohort study of 2- and 3-level ACH and ACDF cases between 2013 and 2021. Degrees of motion were analyzed on flexion/extension views using Cobb angles to measure global (C2-C7) construct and adjacent segment lordosis. Neutral lateral X-rays were analyzed for alignment parameters, including global lordosis, cervical sagittal vertical axis (cSVA), and T1 slope (T1S). Differences were determined by independent t-test and Fisher's exact test. Results: Of 100 patients, 38% were 2-level cases (47% ACH, 53% ACDF) and 62% were 3-level cases: (52% ACH, 48% ACDF). Postoperatively, superior adjacent segment motion increased with ACDF and decreased with ACH (-1.3°±5.3° ACH, 1.6°±4.6° ACDF, P=0.005). Postoperatively, the ACH group had greater ROM across the construct (16.3°±8.7° ACH, 4.7°±3.3° ACDF, P<0.001) and total global ROM (38.0°±12.8° ACH, 28.0°±11.1° ACDF, P<0.001). ACH resulted in a significant reduction of motion loss across the construct (-10.0°±11.7° ACH, -18.1°±10.8° ACDF, P<0.001). Postoperative alignment restoration was similar between both cohorts (-2.61°±8.36° ACH, 0.04°±12.24° ACDF, P=0.21). Conclusions: Compared to ACDF, hybrid constructs partially preserved motion across operative levels and had greater postoperative global ROM without increasing superior adjacent segment mobility or sacrificing alignment restoration. This supports the consideration of ACH in patients with multilevel degenerative cervical pathology requiring at least a 1-level fusion and suggests a propensity for long-term success by reducing the superior adjacent segment burden.
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Introduction: Our research group is conducting three large randomized placebo-controlled trials of medicinal cannabis for cancer symptoms. All participants are invited to take part in a posttrial surveillance study. Methods: Participants were given the manufacturers dosing instructions and liberty to titrate to effect. Data were collected on symptoms (Edmonton Symptom Assessment Scale [ESAS] score), perceived benefits, adverse effects, satisfaction with the product, and dose/frequency. Results: Twenty-six percent of eligible participants consented to take part in the surveillance study. Most participants changed their self-titrated dose at least once. Pain, sleep, and mood were the most frequently cited symptoms which improved. Fatigue, nausea, and cognitive impairment were the most frequently mentioned adverse effects. Conclusion: Participants felt confident making changes to their medicinal cannabis dose within the limits suggested by the manufacturer of each product. A number of benefits and adverse effects were ascribed to the product. Benefits were similar to those described in previous studies.
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Marihuana Medicinal , Neoplasias , Cuidados Paliativos , Humanos , Marihuana Medicinal/uso terapéutico , Marihuana Medicinal/efectos adversos , Masculino , Femenino , Neoplasias/tratamiento farmacológico , Persona de Mediana Edad , Australia , Anciano , Adulto , Anciano de 80 o más AñosRESUMEN
Accurate screw placement is critical to avoid vascular or neurologic complications during spine surgery and to maximize fixation for fusion and deformity correction. Computer-assisted navigation, robotic-guided spine surgery, and augmented reality surgical navigation are currently available technologies that have been developed to improve screw placement accuracy. The advent of multiple generations of new technologies within the past 3 decades has presented surgeons with a diverse array of choices when it comes to pedicle screw placement. Considerations for patient safety and optimal outcomes must be paramount when selecting a technology.
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Realidad Aumentada , Tornillos Pediculares , Procedimientos Quirúrgicos Robotizados , Fusión Vertebral , Cirugía Asistida por Computador , Humanos , Columna VertebralRESUMEN
STUDY DESIGN: Delphi method. OBJECTIVE: To gain consensus on the following questions: (1) When should anticoagulation/antiplatelet (AC/AP) medication be stopped before elective spine surgery?; (2) When should AC/AP medication be restarted after elective spine surgery?; (3) When, how, and in whom should venous thromboembolism (VTE) chemoprophylaxis be started after elective spinal surgery? SUMMARY OF BACKGROUND DATA: VTE can lead to significant morbidity after adult spine surgery, yet postoperative VTE prophylaxis practices vary considerably. The management of preoperative AC/AP medication is similarly heterogeneous. MATERIALS AND METHODS: Delphi method of consensus development consisting of three rounds (January 26, 2021, to June 21, 2021). RESULTS: Twenty-one spine surgeons were invited, and 20 surgeons completed all rounds of questioning. Consensus (>70% agreement) was achieved in 26/27 items. Group consensus stated that preoperative Direct Oral Anticoagulants should be stopped two days before surgery, warfarin stopped five days before surgery, and all remaining AC/AP medication and aspirin should be stopped seven days before surgery. For restarting AC/AP medication postoperatively, consensus was achieved for low-risk/medium-risk/high-risk patients in 5/5 risk factors (VTE history/cardiac/ambulation status/anterior approach/operation). The low/medium/high thresholds were POD7/POD5/POD2, respectively. For VTE chemoprophylaxis, consensus was achieved for low-risk/medium-risk/high-risk patients in 12/13 risk factors (age/BMI/VTE history/cardiac/cancer/hormone therapy/operation/anterior approach/staged separate days/staged same days/operative time/transfusion). The one area that did not gain consensus was same-day staged surgery. The low-threshold/medium-threshold/high-threshold ranges were postoperative day 5 (POD5) or none/POD3-4/POD1-2, respectively. Additional VTE chemoprophylaxis considerations that gained consensus were POD1 defined as the morning after surgery regardless of operating finishing time, enoxaparin as the medication of choice, and standardized, rather than weight-based, dose given once per day. CONCLUSIONS: In the first known Delphi study to address anticoagulation/antiplatelet recommendations for elective spine surgery (preoperatively and postoperatively); our Delphi consensus recommendations from 20 spine surgeons achieved consensus on 26/27 items. These results will potentially help standardize the management of preoperative AC/AP medication and VTE chemoprophylaxis after adult elective spine surgery.
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Tromboembolia Venosa , Adulto , Humanos , Tromboembolia Venosa/etiología , Complicaciones Posoperatorias/etiología , Anticoagulantes/uso terapéutico , Columna Vertebral/cirugía , Inhibidores de Agregación Plaquetaria , Factores de RiesgoRESUMEN
STUDY DESIGN: Prospective cohort study. OBJECTIVES: In spine surgery, accurate screw guidance is critical to achieving satisfactory fixation. Augmented reality (AR) is a novel technology to assist in screw placement and has shown promising results in early studies. This study aims to provide our early experience evaluating safety and efficacy with an Food and Drug Administration-approved head-mounted (head-mounted device augmented reality (HMD-AR)) device. METHODS: Consecutive adult patients undergoing AR-assisted thoracolumbar fusion between October 2020 and August 2021 with 2 -week follow-up were included. Preoperative, intraoperative, and postoperative data were collected to include demographics, complications, revision surgeries, and AR performance. Intraoperative 3D imaging was used to assess screw accuracy using the Gertzbein-Robbins (G-R) grading scale. RESULTS: Thirty-two patients (40.6% male) were included with a total of 222 screws executed using HMD-AR. Intraoperatively, 4 (1.8%) were deemed misplaced and revised using AR or freehand. The remaining 218 (98.2%) screws were placed accurately. There were no intraoperative adverse events or complications, and AR was not abandoned in any case. Of the 208 AR-placed screws with 3D imaging confirmation, 97.1% were considered clinically accurate (91.8% Grade A, 5.3% Grade B). There were no early postoperative surgical complications or revision surgeries during the 2 -week follow-up. CONCLUSIONS: This early experience study reports an overall G-R accuracy of 97.1% across 218 AR-guided screws with no intra or early postoperative complications. This shows that HMD-AR-assisted spine surgery is a safe and accurate tool for pedicle, cortical, and pelvic fixation. Larger studies are needed to continue to support this compelling evolution in spine surgery.
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STUDY DESIGN: Biomechanical Study. OBJECTIVE: The search for optimal spinal alignment has led to the development of sophisticated formulas and software for preoperative planning. However, preoperative plans are not always appropriately executed since rod contouring during surgery is often subjective and estimated by the surgeon. We aimed to assess whether rods contoured to specific angles with a French rod bender using a template guide will be more accurate than rods contoured without a template. METHODS: Ten experienced spine surgeons were requested to contour two 125 × 5.5 mm Ti64 rods to 40°, 60° and 80° without templates and then 2 more rods using 2D metallic templates with the same angles. Rod angles were then measured for accuracy and compared. RESULTS: Average angles for rods bent without a template to 40°, 60° and 80° were 60.2°, 78.9° and 97.5°, respectively. Without a template, rods were overbent by a mean of 18.9°. When using templates of 40°, 60° and 80°, mean bend angles were 41.5°, 59.1° and 78.7°, respectively, with an average underbend of 0.2°. Differences between the template and non-template groups for each target angle were all significant (p < 0.001). CONCLUSIONS: Without the template, surgeons tend to overbend rods compared to the desired angle, while surgeons improved markedly with a template guide. This tendency to overbend could have significant impact on patient outcomes and risk of proximal junctional failure and warrants further research to better enable surgeons to more accurately execute preoperative alignment plans.
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STUDY DESIGN: Retrospective observational cohort. OBJECTIVES: We sought to evaluate the impact of ESR on in-hospital and 90-day postoperative opioid consumption, length of stay, urinary catheter removal and postoperative ambulation after lumbar fusion for degenerative conditions. METHODS: We evaluated patients undergoing lumbar fusion surgery at a single, multi-surgeon center in the transition period prior to (N = 174) and after (N = 116) adoption of ESR, comparing in-hospital and 90-day postoperative opioid consumption. Regression analysis was used to control for confounders. Secondary analysis was preformed to evaluate the association between ESR and length of stay, urinary catheter removal and ambulation after surgery. RESULTS: Mean age study participants was 52.6 years with 62 (47%) females. Demographic characteristics were similar between the Pre-ESR and ESR groups. ESR patients had better 3-month pain scores, ambulated earlier, had urinary catheters removed earlier and decreased in-hospital opioid consumption compared to Pre-ESR patients. There was no difference in 90-day opioid consumption between the 2 groups. Regression analysis showed that ESR was strongly associated with in-hospital opioid consumption, accounting for 30% of the variability in Morphine Milligram Equivalents (MME). In-hospital opioid consumption was also associated with preoperative pain scores, number of surgical levels, and insurance type (private vs government). Pre-op pain sores were associated with 90-day opioid consumption. Secondary analysis showed that ESR was associated with a shorter length of stay and earlier ambulation. CONCLUSIONS: This study showed ESR has the potential to improve recovery after lumbar fusion for degenerative conditions with reduced in-hospital opioid consumption and improved postoperative pain scores.
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Background: The opioid epidemic in the US has led prescribers to reevaluate postoperative pain control particularly in the field of spine surgery, where postoperative analgesia requirements and consumption have historically been high. There is a need to mitigate the quantity of unused pills after surgery by adjusting prescribing practices. Achieving the balance of pain control after surgery without overprescribing opioids may be accomplished by developing a modified approach to prescribing practices; however, there is a need to first understand the opioid requirements of the modern spine surgery patient with respect to their elective spine surgery. Therefore, the primary aim of this study was to determine the percentage of opioids not utilized at 90-days after elective spine surgery. Secondary aims were to identify differences in the percentage of unused opioids between surgical subgroups and preoperative opioid status, to determine factors associated with opioid utilization, and to estimate the distribution of opioids consumed to control pain up to the 90th percentile in each surgical subgroup. Methods: In this prospective, observational cohort study, adults undergoing elective spine surgery at a multi-surgeon, single center were prospectively enrolled and divided into subgroups: anterior cervical, lumbar decompression, and short-segment lumbar fusion. Prescribed MMEs were identified from prescriptions, consumed MMEs were obtained from pill counts, and the percent leftover was calculated. Distributions of MMEs consumed were analyzed to compare utilization between preoperative opioid users or non-users within each surgical subgroup. Results: Of 117 patients, 41.9% were preoperative opioid users. The percentage of unused opioids by surgical subgroup was: 45.4% cervical, 57.3% lumbar decompression, and 37.4% lumbar fusion (p=0.066). The percentage of unused opioids by preoperative opioid exposure was greater in the opioid non-users (58.0%) than users (28.4%, p<0.001)). Regression analysis showed that surgical subgroup and preoperative opioid exposure were associated with leftover opioids. Conclusions: At 90-days, the percentage of unused opioids was over 45% in this cohort of elective spine surgery patients and was nearly double in the group without preoperative opioid exposure. These results suggest the modern elective spine surgery patient is using less opioids than prescribed, supporting the conclusion that the number of MMEs prescribed can be reduced to minimize quantities of leftover pills available for diversion, without sacrificing the priority of appropriate postoperative pain control.
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Introduction: Degenerative disc disease is a common cause of chronic low back pain. Surgical intervention is an invasive treatment associated with high costs. There is growing interest in regenerative medicine as a less invasive but direct disc treatment for chronic discogenic low back pain. Objective: To evaluate clinical improvement of primary discogenic low back pain with intradiscal injection of autologous bone marrow aspirate concentrate (BMAC). Study Design. Prospective cohort study. Setting. Single, multiphysician center. Patients. 32 adult patients undergoing intradiscal injection of autologous BMAC for the treatment of primary discogenic low back pain. Interventions. Intradiscal injection of autologous BMAC. Main Outcome Measures. Primary outcome measure is visual analog back pain scale (VAS back pain). Secondary outcome measures include ODI, VAS leg pain, and EQ-5D-5L scores. Outcomes were compared from baseline to 1 year. Results: Thirty-two patients (56.3% male) with a mean age of 45.9 years were enrolled, giving 92 treated levels. Mean VAS back and leg pain scores improved from 5.4 to 3.0 (p < 0.001) and 2.8 to 1.3 (p = 0.005), respectively. Mean ODI scores decreased from 33.5 to 21.1 (p < 0.001), and EQ-5D-5L scores improved from 0.69 to 0.78 (p = 0.001). Using established MCID values, 59.4% had clinically significant improvement in VAS back pain, 43.8% in VAS leg pain, and 56.3% in ODI scores. Conclusion: Intradiscal injection of autologous BMAC significantly improved low back pain, disability, and quality of life at one year. This study suggests that intradiscal BMAC has the potential to be an effective nonsurgical treatment for chronic discogenic low back pain.
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Minimally invasive spine surgery reduces tissue dissection and retraction, decreasing the morbidity associated with traditional open spine surgery by decreasing blood loss, blood transfusion, complications, and pain. One of the key challenges with a minimally invasive approach is achieving consistent posterior fusion. Although advantageous in all fusion surgeries, solid posterior fusion is particularly important in spinal deformity, revisions, and fusions without anterior column support. A minimally invasive surgical approach accomplished without sacrificing the quality of the posterior fusion has the potential to decrease both short- and long-term complications compared to the traditional open techniques. Innovations in navigated and robotic-assisted spine surgery continue to address this need. In this article, we will outline the feasibility of achieving posterior facet fusion using the Mazor X Stealth Edition Robotic Guidance System.
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Background: Although a growing amount of literature that suggests robots are safe and can achieve comparable outcomes to conventional techniques, much of this literature is limited by small sample sizes and single-surgeon or single center series. Furthermore, it is unclear what the impact of robotic technology has made on operative and clinical outcomes over time. This is the first and largest multicenter study to examine the trends in outcomes and complications after robot-assisted spine surgery over a 5-year period. Methods: Adult (≥18 years old) patients who underwent spine surgery with robot-assistance between 2015 and 2019 at four unique spine centers. The robotic systems used included the Mazor Renaissance, Mazor X, and Mazor Stealth Edition. Patients with incomplete data were excluded from this study. The minimum follow-up was 90 days. Results: A total of 722 adult patients were included (117 Renaissance, 477 X, 128 Stealth). Most patient and operative factors (e.g., sex, tobacco status, total instrumented levels, and pelvic fixation,) were similar across the years. Mean ± standard deviation Charlson comorbidity index (CCI) was 1.5±1.5. The most commonly reported diagnoses included high grade spondylolisthesis (40.6%), degenerative disc disease (18.4%), and degenerative scoliosis (17.6%). Mean (standard deviation) number of instrumented levels was 3.8±3.4. From 2015 to 2019, average robot time per screw improved from 7.2 to 5.5 minutes (P=0.004, R2=0.649). Average fluoroscopy time per screw improved from 15.2 to 9.4 seconds (P=0.002). Rates of both intraoperative screw exchange for misplaced screw (2015-2016: 2.7%, 2019: 0.8%, P=0.0115, R2=0.1316) and robot abandonment (2015-2016: 7.1%, 2019: 1.1%, P=0.011, R2=0.215) improved significantly over time. The incidence of other intraoperative complications (e.g., dural tear, loss of motor/sensory function, blood transfusion) remained consistently low, but similar throughout the years. The length of stay (LOS) decreased by nearly 1 day from 2015 to 2019 (P=0.007, R2=0.779). 90-day reoperation rates did not change significantly. Conclusions: At four institutions among seven surgeons, we demonstrate robot screw accuracy, reliability, operative efficiency, and radiation exposure improved significantly from 2015 to 2019. 90-day complication rates remained low and LOS decreased significantly with time. These findings further validate continued usage of robot-assisted spine surgery and the path toward improved value-based care.
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The study design is retrospective, multi-surgeon, single-center review. The objective is to evaluate complication rates, revision rates, and accuracy grading for robotic-guided S2 alar-iliac (S2AI) screws. Sixty-five consecutive patients underwent S2AI fixation (118 screws) as part of a posterior spine fusion using robotic-guidance. Screws were placed percutaneously in 14 cases and 51 were placed in an open fashion by three board-certified spine surgeons using the Mazor core technology robotic systems (Mazor X, n = 42; Mazor XSE, n = 23). Medical charts were retrospectively reviewed for revisions and complications. All patients were followed for 90 days or greater. Postoperative CT scans were obtained in 22 of the 51 patients, allowing for 46 screws to be reviewed by an independent neuroradiologist who graded the screws for accuracy. There were no intraoperative or postoperative complications associated with S2AI screw placement. There were no revisions found to be related to the S2AI screw placement. All 46 screws evaluated with postoperative CT scans were reported as being at the highest level of accuracy, grade A, with a breach distance of 0 mm (no breach). The robotic-guided technique for S2AI screw placement is a reliable method to achieving pelvic fixation with low complication and revision rates. In addition, a high degree of accuracy can be achieved without relying on visible and tactile landmarks needed for the freehand technique or the additional radiation associated with fluoroscopic-guidance.
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Procedimientos Quirúrgicos Robotizados , Sacro , Tornillos Óseos , Humanos , Ilion/cirugía , Estudios Retrospectivos , Procedimientos Quirúrgicos Robotizados/métodos , Sacro/cirugíaRESUMEN
OBJECTIVE: Robotics is a major area for research and development in spine surgery. The high accuracy of robot-assisted placement of thoracolumbar pedicle screws is documented in the literature. The authors present the largest case series to date evaluating 90-day complication, revision, and readmission rates for robot-assisted spine surgery using the current generation of robotic guidance systems. METHODS: An analysis of a retrospective, multicenter database of open and minimally invasive thoracolumbar instrumented fusion surgeries using the Mazor X or Mazor X Stealth Edition robotic guidance systems was performed. Patients 18 years of age or older and undergoing primary or revision surgery for degenerative spinal conditions were included. Descriptive statistics were used to calculate rates of malpositioned screws requiring revision, as well as overall complication, revision, and readmission rates within 90 days. RESULTS: In total, 799 surgical cases (Mazor X: 48.81%; Mazor X Stealth Edition: 51.19%) were evaluated, involving robot-assisted placement of 4838 pedicle screws. The overall intraoperative complication rate was 3.13%. No intraoperative implant-related complications were encountered. Postoperatively, 129 patients suffered a total of 146 complications by 90 days, representing an incidence of 16.1%. The rate of an unrecognized malpositioned screw resulting in a new postoperative radiculopathy requiring revision surgery was 0.63% (5 cases). Medical and pain-related complications unrelated to hardware placement accounted for the bulk of postoperative complications within 90 days. The overall surgical revision rate at 90 days was 6.63% with 7 implant-related revisions, representing an implant-related revision rate of 0.88%. The 90-day readmission rate was 7.13% with 2 implant-related readmissions, representing an implant-related readmission rate of 0.25% of cases. CONCLUSIONS: The results of this multicenter case series and literature review suggest current-generation robotic guidance systems are associated with low rates of intraoperative and postoperative implant-related complications, revisions, and readmissions at 90 days. Future outcomes-based studies are necessary to evaluate complication, revision, and readmission rates compared to conventional surgery.
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PURPOSE: Retrospective observational cohort study of primary adult spinal deformity (ASD) surgery during the transitional period prior to and after the implementation of Enhanced Surgical Recovery (ESR) at a single center. We sought to determine if ESR reduces in-hospital and 90-day post-operative opioid consumption for ASD surgery. METHODS: We evaluated patients undergoing primary ASD surgery in the transition period prior to (N = 29) and after (N = 56) adoption of ESR, comparing in-hospital and 90-day post-operative opioid consumption. Regression analysis was used to control for confounders including age, number of surgical levels, surgical approach, staged vs same-day surgery, insurance type and pre-op opioid use. RESULTS: Mean age of the cohort was 53 years with 57 (60%) females. Regression analysis showed that pre-operative opioid use and number of levels fused were associated with higher in-hospital and 90-day post-operative opioid consumption, while use of ESR was associated with lower in-hospital and 90-day post-operative opioid consumption. Secondary analysis showed that patients on ESR ambulated earlier (0.6 days vs 1.1, p = 0.028) and had their urinary catheter removed earlier (2.7 days vs 3.9, p = 0.006) compared to non-ESR patients. CONCLUSIONS: ESR was associated with a significantly decreased in-hospital and 90-day post-operative opioid consumption and earlier mobilization with earlier urinary catheter removal in patients undergoing primary ASD surgery. These results demonstrate ESR's potential to improve outcomes in ASD perioperative care. LEVEL OF EVIDENCE: 3.
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Analgésicos Opioides , Recuperación Mejorada Después de la Cirugía , Adulto , Analgésicos Opioides/uso terapéutico , Estudios de Cohortes , Femenino , Hospitales , Humanos , Persona de Mediana Edad , Procedimientos Neuroquirúrgicos , Estudios RetrospectivosRESUMEN
STUDY DESIGN: Multicenter cohort. OBJECTIVE: To compare the robot time/screw, radiation exposure, robot abandonment, screw accuracy, and 90-day outcomes between robot-assisted percutaneous and robot-assisted open approach for short lumbar fusion (1- and 2-level). SUMMARY OF BACKGROUND DATA: There is conflicting literature on the superiority of robot-assisted minimally invasive spine surgery to open techniques. A large, multicenter study is needed to further elucidate the outcomes and complications between these two approaches. METHODS: We included adult patients (≥18 yrs old) who underwent robot-assisted short lumbar fusion surgery from 2015 to 2019 at four independent institutions. A propensity score matching algorithm was employed to control for the potential selection bias between percutaneous and open surgery. The minimum follow-up was 90âdays after the index surgery. RESULTS: After propensity score matching, 310 patients remained. The mean (standard deviation) Charlson comorbidity index was 1.6 (1.5) and 53% of patients were female. The most common diagnoses included high-grade spondylolisthesis (grade >2) (48%), degenerative disc disease (22%), and spinal stenosis (25%), and the mean number of instrumented levels was 1.5(0.5). The operative time was longer in the open (198âmin) versus the percutaneous group (167âmin, P valueâ=â0.007). However, the robot time/screw was similar between cohorts (P valueâ>â0.05). The fluoroscopy time/ screw for percutaneous (14.4âs) was longer than the open group (10.1âs, P valueâ=â0.021). The rates for screw exchange and robot abandonment were similar between groups (P valueâ>â0.05). The estimated blood loss (open: 146âmL vs. percutaneous: 61.3âmL, P valueâ<â0.001) and transfusion rate (open: 3.9% vs. percutaneous: 0%, P valueâ=â0.013) were greater for the open group. The 90-day complication rate and mean length of stay were not different between cohorts (P valueâ>â0.05). CONCLUSION: Percutaneous robot-assisted spine surgery may increase radiation exposure, but can achieve a shorter operative time and lower risk for intraoperative blood loss for short-lumbar fusion. Percutaneous approaches do not appear to have an advantage for other short-term postoperative outcomes. Future multicenter studies on longer fusion surgeries and the inclusion of patient-reported outcomes are needed.Level of Evidence: 3.
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Tornillos Pediculares , Exposición a la Radiación , Robótica , Fusión Vertebral , Adulto , Femenino , Humanos , Vértebras Lumbares/diagnóstico por imagen , Vértebras Lumbares/cirugía , Procedimientos Quirúrgicos Mínimamente Invasivos , Fusión Vertebral/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND CONTEXT: Robot-assisted spine surgery continues to rapidly develop as evidenced by the growing literature in recent years. In addition to demonstrating excellent pedicle screw accuracy, early studies have explored the impact of robot-assisted spine surgery on reducing radiation time, length of hospital stay, operative time, and perioperative complications in comparison to conventional freehand technique. Recently, the Mazor X Stealth Edition was introduced in 2018. This robotic system integrates Medtronic's Stealth navigation technology into the Mazor X platform, which was introduced in 2016. It is unclear what the impact of these advancements have made on clinical outcomes. PURPOSE: To compare the outcomes and complications between the most recent iterations of the Mazor Robot systems: Mazor X and Mazor X Stealth Edition. STUDY DESIGN: Multicenter cohort PATIENT SAMPLE: Among four different institutions, we included adult (≥18 years old) patients who underwent robot-assisted spine surgery with either the Mazor X (non-navigated robot) or Stealth (navigated robot) platforms. OUTCOME MEASURES: Primary outcomes included robot time per screw, fluoroscopic radiation time, screw accuracy, robot abandonment, and clinical outcomes with a minimum 90 day follow up. METHODS: A one-to-one propensity-score matching algorithm based on perioperative factors (e.g. demographics, comorbidities, primary diagnosis, open vs. percutaneous instrumentation, prior spine surgery, instrumented levels, pelvic fixation, interbody fusion, number of planned robot screws) was employed to control for the potential selection bias between the two robotic systems. Chi-square/fisher exact test and t-test/ANOVA were used for categorical and continuous variables, respectively. RESULTS: From a total of 646 patients, a total of 372 adult patients were included in this study (X: 186, Stealth: 186) after propensity score matching. The mean number of instrumented levels was 4.3. The mean number of planned robot screws was 7.8. Similar total operative time and robot time per screw occurred between cohorts (p>0.05). However, Stealth achieved significantly shorter fluoroscopic radiation time per screw (Stealth: 7.2 seconds vs. X: 10.4 seconds, p<.001) than X. The screw accuracy for both robots was excellent (Stealth: 99.6% vs. X: 99.1%, p=0.120). In addition, Stealth achieved a significantly lower robot abandonment rate (Stealth: 0% vs. X: 2.2%, p=0.044). Furthermore, a lower blood transfusion rate was observed for Stealth than X (Stealth: 4.3% vs. X: 10.8%, p=0.018). Non-robot related complications such as dura tear, motor/sensory deficits, return to the operating room during same admission, and length of stay was similar between robots (p>0.05). The 90-day complication rates were low and similar between robot cohorts (Stealth: 5.4% vs. X: 3.8%, p=0.456). CONCLUSION: In this multicenter study, both robot systems achieved excellent screw accuracy and low robot time per screw. However, using Stealth led to significantly less fluoroscopic radiation time, lower robot abandonment rates, and reduced blood transfusion rates than Mazor X. Other factors including length of stay, and 90-day complications were similar.
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Tornillos Pediculares , Procedimientos Quirúrgicos Robotizados , Robótica , Fusión Vertebral , Adolescente , Adulto , Humanos , Columna Vertebral/cirugíaRESUMEN
BACKGROUND: Robot-assisted platforms in spine surgery have rapidly developed into an attractive technology for both the surgeon and patient. Although current literature is promising, more clinical data is needed. The purpose of this paper is to determine the effect of robot-related complications on clinical outcomes METHODS: This multicenter study included adult (≥18 years old) patients who underwent robot-assisted lumbar fusion surgery from 2012-2019. The minimum follow-up was 1 year after surgery. Both bivariate and multivariate analyses were performed to determine if robot-related factors were associated with reoperation within 1 year after primary surgery. RESULTS: A total of 320 patients were included in this study. The mean (standard deviation) Charlson Comorbidity Index was 1.2 (1.2) and 52.5% of patients were female. Intraoperative robot complications occurred in 3.4% of patients and included intraoperative exchange of screw (0.9%), robot abandonment (2.5%), and return to the operating room for screw exchange (1.3%). The 1-year reoperation rate was 4.4%. Robot factors, including robot time per screw, open vs. percutaneous, and robot system, were not statistically different between those who required revision surgery and those who did not (P>0.05). Patients with robot complications were more likely to have prolonged length of hospital stay and blood transfusion, but were not at higher risk for 1-year reoperations. The most common reasons for reoperation were wound complications (2.2%) and persistent symptoms due to inadequate decompression (1.5%). In the multivariate analysis, robot related factors and complications were not independent risk factors for 1-year reoperations. CONCLUSION: This is the largest multicenter study to focus on robot-assisted lumbar fusion outcomes. Our findings demonstrate that 1-year reoperation rates are low and do not appear to be influenced by robot-related factors and complications; however, robot-related complications may increase the risk for greater blood loss requiring a blood transfusion and longer length of stay.
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Artrodesis/efectos adversos , Vértebras Lumbares/cirugía , Reoperación , Procedimientos Quirúrgicos Robotizados/efectos adversos , Fusión Vertebral/efectos adversos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Artrodesis/métodos , Transfusión Sanguínea/estadística & datos numéricos , Femenino , Humanos , Complicaciones Intraoperatorias/epidemiología , Complicaciones Intraoperatorias/etiología , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Riesgo , Factores de Riesgo , Procedimientos Quirúrgicos Robotizados/métodos , Fusión Vertebral/métodos , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
STUDY DESIGN: Prospective, multicenter, partially randomized. OBJECTIVE: Assess rates of complications, revision surgery, and radiation between Mazor robotic-guidance (RG) and fluoro-guidance (FG). SUMMARY OF BACKGROUND DATA: Minimally invasive surgery MIS ReFRESH is the first study designed to compare RG and FG techniques in adult minimally invasive surgery (MIS) lumbar fusions. METHODS: Primary endpoints were analyzed at 1âyear follow-up. Analysis of variables through Cox logistic regression and a Kaplan-Meier Survival Curve of surgical complications. RESULTS: Nine sites enrolled 485 patients: 374 (RG arm) and 111 (FG arm). 93.2% of patients had more than 1âyear f/u. There were no differences for sex, Charlson Comorbidity Index, diabetes, or tumor. Mean age of RG patients was 59.0 versus 62.5 for FG (Pâ=â0.009) and body mass index (BMI) was 31.2 versus 28.1 (P< 0.001). Percentage of smokers was almost double in the RG (15.2% vs. 7.2%, Pâ=â0.029). Surgical time was similar (skin-to-skin time/no. of screws) at 24.9 minutes RG and 22.9 FG (Pâ=â0.550). Fluoroscopy during surgery/no. of screws was 15.5âseconds RG versus 35.4âseconds FG, (15 seconds average reduction). Fluoroscopy time during instrumentation/no. of screws was 3.6âseconds RG versus 17.8âseconds FG showing an 80% average reduction of fluoro time/screw in RG (Pâ<â0.001). Within 1âyear follow-up, there were 39 (10.4%) surgical complications RG versus 39 (35.1%) FG, and 8 (2.1%) revisions RG versus 7 (6.3%) FG. Cox regression analysis including age, sex, BMI, CCI, and no. of screws, demonstrated that the hazard ratio (HR) for complication was 5.8 times higher FG versus RG (95% CI: 3.5-9.6, Pâ<â0.001). HR for revision surgery was 11.0 times higher FG versus RG cases (95% CI 2.9-41.2, Pâ<â0.001). CONCLUSION: Mazor robotic-guidance was found to have a 5.8 times lower risk of a surgical complication and 11.0 times lower risk for revision surgery. Surgical time was similar between groups and robotic-guidance reduced fluoro time per screw by 80% (approximately 1âmin/case).Level of Evidence: 2.
Asunto(s)
Tornillos Pediculares , Procedimientos Quirúrgicos Robotizados , Fusión Vertebral , Adulto , Fluoroscopía , Humanos , Vértebras Lumbares , Procedimientos Quirúrgicos Mínimamente Invasivos , Estudios Prospectivos , Estudios Retrospectivos , Procedimientos Quirúrgicos Robotizados/efectos adversos , Fusión Vertebral/efectos adversosRESUMEN
Studies evaluating robotic guidance in lumbar fusion are limited primarily to evaluation of screw accuracy and perioperative complications. This is the first study to evaluate granular differences in short and long-term complication and revision rate profiles between robotic (RG) fluoroscopic (FG) guidance for minimally invasive short-segment lumbar fusions. A retrospective analysis of a prospective, multi-center database was performed. Complications were subdivided into surgical (further subcategorized into adjacent segment disease, new-onset back pain, radiculopathy, motor-deficit, hardware failure, pseudoarthrosis), wound, and medical complications. Complication and revision rates were compared between RG and FG groups cumulatively at 30, 90 days, and 1 year. 374 RG and 111 FG procedures were performed. RG was associated with an 86.25, 83.20, and 69.42% cumulative reduction in complication rate at 30, 90 days, and 1 year, respectively, compared to FG (p < 0.001). At all follow-up points, new-onset radiculopathy and medical complications were most prevalent in both groups. The greatest reductions in complication rates were seen for new-onset back pain (88.13%; p = 0.001) and wound complications (95.05%; p < 0.001) at 30 days, new-onset motor deficits (90.11%; p = 0.004) and wound complications (85.16%; p < 0.001) at 90 days, and new-onset motor deficits (85.16%; p = 0.002), wound (85.16%; p < 0.001), and medical complications (75.72%; p < 0.001) at 1 year. RG was associated with a 92.58% (p = 0.002) reduction in revision rate at 90 days and a 66.08% (p = 0.026) reduction at 1 year. RG was associated with significant reductions in postoperative complication rates at all follow-up time points and significant reductions in revision rates at 90 days and 1 year.
Asunto(s)
Tornillos Pediculares , Procedimientos Quirúrgicos Robotizados , Fusión Vertebral , Humanos , Vértebras Lumbares/cirugía , Estudios Prospectivos , Estudios Retrospectivos , Procedimientos Quirúrgicos Robotizados/métodos , Fusión Vertebral/efectos adversosRESUMEN
Robotic-assisted spine surgery has a number of potential advantages, including more precise pre-operative planning, a high degree of accuracy in screw placement, and significantly reduced radiation exposure to the surgical team. While the current primary goal of these systems is to improve the safety of spine surgery by increasing screw accuracy, there are a number of technical errors that may increase the risk of screw malposition. Given the learning curve associated with this technology, it is important for the surgeon to have a thorough understanding of all required steps. In this article, we will demonstrate the setup and workflow of a combined navigation and robotic spine surgery platform using the Mazor X Stealth Edition (MXSE) system to place cortical-based trajectory (CBT) screws, including a review of all technical tips and pearls to efficiently perform this procedure with minimal risk of screw malposition. In this article, we will review surgical planning, operating room setup, robotic arm mounting, registration, and CBT screw placement using the MXSE system.