Durotomy- and Irrigation-Related Serious Adverse Events During Spinal Endoscopy: Illustrative Case Series and International Surgeon Survey.

BACKGROUND: Durotomy during endoscopic spine surgery can cause a patient's neurological or cardiovascular status to deteriorate unexpectedly intra- or postoperatively. There is currently limited literature regarding appropriate fluid management strategies, irrigation-related risk factors, and clinical consequences of incidental durotomy during spinal endoscopy, and no validated irrigation protocol exists for endoscopic spine surgery. Thus, the present article sought to (1) describe 3 cases of durotomy, (2) investigate standard epidural pressure measurements, and (3) survey endoscopic spine surgeons on the incidence of adverse effects believed to result from durotomy. MATERIALS AND METHODS: The authors first reviewed clinical outcomes and analyzed complications in 3 patients with intraoperatively recognized incidental durotomy. Second, the authors conducted a small case series with intraoperative epidural pressure measurements during gravity-assisted irrigated video endoscopy of the lumbar spine. Measurements were conducted on 12 patients with a transducer assembly that was introduced through the endoscopic working channel of the RIWOSpine Panoview Plus and Vertebris endoscope to the decompression site in the spine. Third, the authors conducted a retrospective, multiple-choice survey of endoscopic spine surgeons to better understand the frequency and seriousness of problems they attributed to irrigation fluid escaping from the surgical decompression site into the spinal canal and neural axis. Descriptive and correlative statistical analyses were performed on the surgeons' responses. RESULTS: In the first part of this study, durotomy-related complications during irrigated spinal endoscopy were observed in 3 patients. Postoperative head computed tomographic (CT) images revealed massive blood in the intracranial subarachnoid space, the basal cisterns, the III and IV ventricle, and the lateral ventricles characteristic of an arterial fisher grade IV subarachnoid hemorrhage, and hydrocephalus without evidence of aneurysms or angiomas. Two additional patients developed intraoperative seizures, cardiac arrhythmia, and hypotension. The head CT image in 1 of these 2 patients had intracranial air entrapment.In the second part, epidural pressure measurements in 12 patients who underwent uneventful routine lumbar interlaminar decompression for L4-L5 and L5-S1 disc herniation showed an average epidural pressure of 24.5 mm Hg.In the third part, the online survey was accessed by 766 spine surgeons worldwide and had a response rate of 43.6%. Irrigation-related problems were reported by 38% of responding surgeons. Only 11.8% used irrigation pumps, with 90% running the pump above 40 mm Hg. Headaches (4.5%) and neck pain (4.9%) were observed by nearly a 10th (9.4%) of surgeons. Seizures in combination with headaches, neck and abdominal pain, soft tissue edema, and nerve root injury were reported by another 5 surgeons. One surgeon reported a delirious patient. Another 14 surgeons thought that they had patients with neurological deficits ranging from nerve root injury to cauda equina syndrome related to irrigation fluid. Autonomic dysreflexia associated with hypertension was attributed by 19 of the 244 responding surgeons to the noxious stimulus of escaped irrigation fluid that migrated from the decompression site in the spinal canal. Two of these 19 surgeons reported 1 case associated with a recognized incidental durotomy and another with postoperative paralysis. CONCLUSIONS: Patients should be educated preoperatively about the risk of irrigated spinal endoscopy. Although rare, intracranial blood, hydrocephalus, headaches, neck pain, seizures, and more severe complications, including life-threatening autonomic dysreflexia with hypertension, may arise if irrigation fluid enters the spinal canal or the dural sac and migrates from the endoscopic site along the neural axis rostrally. Experienced endoscopic spine surgeons suspect a correlation between durotomy and irrigation-related extra- and intradural pressure equalization that could be problematic if associated with high volumes of irrigation fluid LEVEL OF EVIDENCE: 3.

Personalized Interventional Surgery of the Lumbar Spine: A Perspective on Minimally Invasive and Neuroendoscopic Decompression for Spinal Stenosis.

Pain generator-based lumbar spinal decompression surgery is the backbone of modern spine care. In contrast to traditional image-based medical necessity criteria for spinal surgery, assessing the severity of neural element encroachment, instability, and deformity, staged management of common painful degenerative lumbar spine conditions is likely to be more durable and cost-effective. Targeting validated pain generators can be accomplished with simplified decompression procedures associated with lower perioperative complications and long-term revision rates. In this perspective article, the authors summarize the current concepts of successful management of spinal stenosis patients with modern transforaminal endoscopic and translaminar minimally invasive spinal surgery techniques. They represent the consensus statements of 14 international surgeon societies, who have worked in collaborative teams in an open peer-review model based on a systematic review of the existing literature and grading the strength of its clinical evidence. The authors found that personalized clinical care protocols for lumbar spinal stenosis rooted in validated pain generators can successfully treat most patients with sciatica-type back and leg pain including those who fail to meet traditional image-based medical necessity criteria for surgery since nearly half of the surgically treated pain generators are not shown on the preoperative MRI scan. Common pain generators in the lumbar spine include (a) an inflamed disc, (b) an inflamed nerve, (c) a hypervascular scar, (d) a hypertrophied superior articular process (SAP) and ligamentum flavum, (e) a tender capsule, (f) an impacting facet margin, (g) a superior foraminal facet osteophyte and cyst, (h) a superior foraminal ligament impingement, (i) a hidden shoulder osteophyte. The position of the key opinion authors of the perspective article is that further clinical research will continue to validate pain generator-based treatment protocols for lumbar spinal stenosis. The endoscopic technology platform enables spine surgeons to directly visualize pain generators, forming the basis for more simplified targeted surgical pain management therapies. Limitations of this care model are dictated by appropriate patient selection and mastering the learning curve of modern MIS procedures. Decompensated deformity and instability will likely continue to be treated with open corrective surgery. Vertically integrated outpatient spine care programs are the most suitable setting for executing such pain generator-focused programs.

Endoscopic Posterior Cervical Decompression for Ossified Posterior Longitudinal Ligament: A Technical Note.

BACKGROUND: Ossification of the posterior longitudinal ligament (OPLL) may cause cervical myelopathy. In its multilevel form, it may not be easy to manage. Minimally invasive endoscopic posterior cervical decompression may be an alternative to traditional laminectomy surgery. METHODS: Thirteen patients with multilevel OPLL and symptomatic cervical myelopathy were treated with endoscopic spine surgery from January 2019 to June 2020. In this consecutive observational cohort study, pre- and postoperative Japanese Orthopaedic Association (JOA) score and Neck Disability Index (NDI) were analyzed at a final follow-up of 2 years postoperatively. RESULTS: There were 13 patients consisting of 3 women and 10 men. The patient's average age was 51.15 years. At the final 2-year follow-up, the JOA score improved from a preoperative value of 10.85 ± 2.91 to 14.77 ± 2.13 postoperatively (P < 0.001). The corresponding NDI scores decreased from 26.61 ± 12.88 to 11.12 ± 10.85 (P < 0.001). There were no infections, wound complications, or reoperations. CONCLUSION: Direct posterior endoscopic decompression for multilevel OPLL is feasible in symptomatic patients when executed at a high skill level. While 2-year outcomes were encouraging and on par with historic data obtained with traditional laminectomy, future studies will need to show whether any long-term shortcomings exist.

The Changing Environment in Postgraduate Education in Orthopedic Surgery and Neurosurgery and Its Impact on Technology-Driven Targeted Interventional and Surgical Pain Management: Perspectives from Europe, Latin America, Asia, and The United States.

Personalized care models are dominating modern medicine. These models are rooted in teaching future physicians the skill set to keep up with innovation. In orthopedic surgery and neurosurgery, education is increasingly influenced by augmented reality, simulation, navigation, robotics, and in some cases, artificial intelligence. The postpandemic learning environment has also changed, emphasizing online learning and skill- and competency-based teaching models incorporating clinical and bench-top research. Attempts to improve work-life balance and minimize physician burnout have led to work-hour restrictions in postgraduate training programs. These restrictions have made it particularly challenging for orthopedic and neurosurgery residents to acquire the knowledge and skill set to meet the requirements for certification. The fast-paced flow of information and the rapid implementation of innovation require higher efficiencies in the modern postgraduate training environment. However, what is taught typically lags several years behind. Examples include minimally invasive tissue-sparing techniques through tubular small-bladed retractor systems, robotic and navigation, endoscopic, patient-specific implants made possible by advances in imaging technology and 3D printing, and regenerative strategies. Currently, the traditional roles of mentee and mentor are being redefined. The future orthopedic surgeons and neurosurgeons involved in personalized surgical pain management will need to be versed in several disciplines ranging from bioengineering, basic research, computer, social and health sciences, clinical study, trial design, public health policy development, and economic accountability. Solutions to the fast-paced innovation cycle in orthopedic surgery and neurosurgery include adaptive learning skills to seize opportunities for innovation with execution and implementation by facilitating translational research and clinical program development across traditional boundaries between clinical and nonclinical specialties. Preparing the future generation of surgeons to have the aptitude to keep up with the rapid technological advances is challenging for postgraduate residency programs and accreditation agencies. However, implementing clinical protocol change when the entrepreneur-investigator surgeon substantiates it with high-grade clinical evidence is at the heart of personalized surgical pain management.

Clinical Consequences of Incidental Durotomy during Full-Endoscopic Lumbar Decompression Surgery in Relation to Intraoperative Epidural Pressure Measurements.

Background: Seizures, neurological deficits, bradycardia, and, in the worst cases, cardiac arrest may occur following incidental durotomy during routine lumbar endoscopy. Therefore, we set out to measure the intraoperative epidural pressure during lumbar endoscopic decompression surgery. Methods: We conducted a retrospective observational cohort study to obtain intraoperative epidural measurements with an epidural catheter-pressure transducer assembly through the spinal endoscope on 15 patients who underwent lumbar endoscopic decompression of symptomatic lumbar herniated discs and spinal stenosis. The endoscopic interlaminar technique was employed. Results: There were six (40.0%) female and nine (60.0%) male patients aged 49.0667 ± 11.31034, ranging from 36 to 72 years, with an average follow-up of 35.15 ± 12.48 months. Three of the fifteen patients had seizures with durotomy and one of these three had intracranial air on their postoperative brain CT. Another patient developed spinal headaches and diplopia on postoperative day one when her deteriorating neurological function was investigated with a brain computed tomography (CT) scan, showing an intraventricular hemorrhage consistent with a Fisher Grade IV subarachnoid hemorrhage. A CT angiogram did not show any abnormalities. Pressure recordings in the epidural space in nine patients ranged from 20 to 29 mm Hg with a mean of 24.33 mm Hg. Conclusion: Most incidental durotomies encountered during lumbar interlaminar endoscopy can be managed without formal repair and supportive care measures. The intradural spread of irrigation fluid and intraoperatively used drugs and air entrapment through an unrecognized durotomy should be suspected if patients deteriorate in the recovery room. Ascending paralysis may cause nausea, vomiting, upper and lower motor neuron symptoms, cranial nerve palsies, hypotension, bradycardia, and respiratory and cardiac arrest. The recovery team should be prepared to manage these complications.

Identification of the Magna Radicular Artery Entry Foramen and Adamkiewicz System: Patient Selection for Open versus Full-Endoscopic Thoracic Spinal Decompression Surgery.

BACKGROUND: Casually cauterizing the radicular magna during routine thoracic discectomy may have dire consequences. METHODS: We performed a retrospective observational cohort study on patients scheduled for decompression of symptomatic thoracic herniated discs and spinal stenosis who underwent a preoperative computed tomography angiography (CTA) to assess the surgical risks by anatomically defining the foraminal entry level of the magna radicularis artery into the thoracic spinal cord and its relationship to the surgical level. RESULTS: Fifteen patients aged 58.53 ± 19.57, ranging from 31 to 89 years, with an average follow-up of 30.13 ± 13.42 months, were enrolled in this observational cohort study. The mean preoperative VAS for axial back pain was VAS of 8.53 ± 2.06 and reduced to a postoperative VAS of 1.60 ± 0.92 (p < 0.0001) at the final follow-up. The Adamkiewicz was most frequently found at T10/11 (15.4%), T11/12 (23.1%), and T9/10 (30.8%). There were eight patients where the painful pathology was found far from the AKA foraminal entry-level (type 1), three patients with near location (type 2), and another four patients needing decompression at the foraminal (type 3) entry-level. In five of the fifteen patients, the magna radicularis entered the spinal canal on the ventral surface of the exiting nerve root through the neuroforamen at the surgical level requiring a change of surgical strategy to prevent injury to this important contributor to the spinal cord's blood supply. CONCLUSIONS: The authors recommend stratifying patients according to the proximity of the magna radicularis artery to the compressive pathology with CTA to assess the surgical risk with targeted thoracic discectomy methods.

Joint International SILACO, SICCMII, ISASS Symposium as a Model for a Collaborative Framework to Create Literature on Advances in Spine Surgery, Patient Care, and Policy.

International collaborations can be the key to overcoming innovation implementation hurdles. The authors report on a joint symposium between the International Society For The Advancement of Spine Surgery (ISASS) and La Sociedad Iberolatinoamerica de Columna (SILACO), and La Sociedad Interamericana de Cirurgia de columna de Minima invasión (SICCMII) aimed at improving joint surgeon education programs. The symposium highlighted that patient-related spine care issues are similar across geographical, cultural, and language barriers. The sustainability of such programs depends on funding and mutually respectful relationships orchestrated by multi-lingual leaders who will bridge gaps created by geographical, cultural, and language barriers to effectively develop clinical research content focused on advancing surgeon education and improving patient outcomes across the Americas.

A Proposed Personalized Spine Care Protocol (SpineScreen) to Treat Visualized Pain Generators: An Illustrative Study Comparing Clinical Outcomes and Postoperative Reoperations between Targeted Endoscopic Lumbar Decompression Surgery, Minimally Invasive TLIF and Open Laminectomy.

Background: Endoscopically visualized spine surgery has become an essential tool that aids in identifying and treating anatomical spine pathologies that are not well demonstrated by traditional advanced imaging, including MRI. These pathologies may be visualized during endoscopic lumbar decompression (ELD) and categorized into primary pain generators (PPG). Identifying these PPGs provides crucial information for a successful outcome with ELD and forms the basis for our proposed personalized spine care protocol (SpineScreen). Methods: a prospective study of 412 patients from 7 endoscopic practices consisting of 207 (50.2%) males and 205 (49.8%) females with an average age of 63.67 years and an average follow-up of 69.27 months was performed to compare the durability of targeted ELD based on validated primary pain generators versus image-based open lumbar laminectomy, and minimally invasive lumbar transforaminal interbody fusion (TLIF) using Kaplan-Meier median survival calculations. The serial time was determined as the interval between index surgery and when patients were censored for additional interventional and surgical treatments for low back-related symptoms. A control group was recruited from patients referred for a surgical consultation but declined interventional and surgical treatment and continued on medical care. Control group patients were censored when they crossed over into any surgical or interventional treatment group. Results: of the 412 study patients, 206 underwent ELD (50.0%), 61 laminectomy (14.8%), and 78 (18.9%) TLIF. There were 67 patients in the control group (16.3% of 412 patients). The most common surgical levels were L4/5 (41.3%), L5/S1 (25.0%), and L4-S1 (16.3%). At two-year f/u, excellent and good Macnab outcomes were reported by 346 of the 412 study patients (84.0%). The VAS leg pain score reduction was 4.250 ± 1.691 (p < 0.001). No other treatment during the available follow-up was required in 60.7% (125/206) of the ELD, 39.9% (31/78) of the TLIF, and 19.7% (12/61 of the laminectomy patients. In control patients, only 15 of the 67 (22.4%) control patients continued with conservative care until final follow-up, all of which had fair and poor functional Macnab outcomes. In patients with Excellent Macnab outcomes, the median durability was 62 months in ELD, 43 in TLIF, and 31 months in laminectomy patients (p < 0.001). The overall survival time in control patients was eight months with a standard error of 0.942, a lower boundary of 6.154, and an upper boundary of 9.846 months. In patients with excellent Macnab outcomes, the median durability was 62 months in ELD, 43 in TLIF, and 31 months in laminectomy patients versus control patients at seven months (p < 0.001). The most common new-onset symptom for censoring was dysesthesia ELD (9.4%; 20/206), axial back pain in TLIF (25.6%;20/78), and recurrent pain in laminectomy (65.6%; 40/61) patients (p < 0.001). Transforaminal epidural steroid injections were tried in 11.7% (24/206) of ELD, 23.1% (18/78) of TLIF, and 36.1% (22/61) of the laminectomy patients. The secondary fusion rate among ELD patients was 8.8% (18/206). Among TLIF patients, the most common additional treatments were revision fusion (19.2%; 15/78) and multilevel rhizotomy (10.3%; 8/78). Common follow-up procedures in laminectomy patients included revision laminectomy (16.4%; 10/61), revision ELD (11.5%; 7/61), and multilevel rhizotomy (11.5%; 7/61). Control patients crossed over into ELD (13.4%), TLIF (13.4%), laminectomy (10.4%) and interventional treatment (40.3%) arms at high rates. Most control patients treated with spinal injections (55.5%) had excellent and good functional outcomes versus 40.7% with fair and poor (3.7%), respectively. The control patients (93.3%) who remained in medical management without surgery or interventional care (14/67) had the worst functional outcomes and were rated as fair and poor. Conclusions: clinical outcomes were more favorable with lumbar surgeries than with non-surgical control groups. Of the control patients, the crossover rate into interventional and surgical care was 40.3% and 37.2%, respectively. There are longer symptom-free intervals after targeted ELD than with TLIF or laminectomy. Additional intervention and surgical treatments are more often needed to manage new-onset postoperative symptoms in TLIF- and laminectomy compared to ELD patients. Few ELD patients will require fusion in the future. Considering the rising cost of surgical spine care, we offer SpineScreen as a simplified and less costly alternative to traditional image-based care models by focusing on primary pain generators rather than image-based criteria derived from the preoperative lumbar MRI scan.

Differential Agnostic Effect Size Analysis of Lumbar Stenosis Surgeries.

STUDY DESIGN: A meta-analysis of 89 randomized prospective, prospective, and retrospective studies on spinal endoscopic surgery outcomes. OBJECTIVE: The study aimed to provide familiar Oswestry Disability Index (ODI), visual analog scale (VAS) back, and VAS leg effect size (ES) data following endoscopic decompression for sciatica-type back and leg pain due to lumbar herniated disc, foraminal, or lateral recess spinal stenosis. BACKGROUND: Higher-grade objective clinical outcome ES data are more suitable than lower-grade clinical evidence, including cross-sectional retrospective study outcomes or expert opinion to underpin the ongoing debate on whether or not to replace some of the traditional open and with other forms of minimally invasive spinal decompression surgeries such as the endoscopic technique. METHODS: A systematic search of PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials from 1 January 2000 to 31 December 2019 identified 89 eligible studies on lumbar endoscopic decompression surgery enrolling 23,290 patient samples using the ODI and VAS for back and leg pain used for the ES calculation. RESULTS: There was an overall mean overall reduction of ODI of 46.25 (SD 6.10), VAS back decrease of 3.29 (SD 0.65), and VAS leg reduction of 5.77 (SD 0.66), respectively. Reference tables of familiar ODI, VAS back, and VAS leg show no significant impact of study design, follow-up, or patients' age on ES observed with these outcome instruments. There was no correlation of ES with long-term follow-up (P = 0.091). Spinal endoscopy produced an overall ODI ES of 0.92 extrapolated from 81 studies totaling 12,710 patient samples. Provided study comparisons to tubular retractor microdiscectomy and open laminectomy showed an ODI ES of 0.9 (2895 patients pooled from 16 studies) and 0.93 (1188 patients pooled from 5 studies). The corresponding VAS leg ES were 0.92 (12,631 endoscopy patients pooled from 81 studies), 0.92 (2348 microdiscectomy patients pooled from 15 studies), and 0.89 (1188 open laminectomy patients pooled from 5 studies). CONCLUSION: Successful clinical outcomes can be achieved with various lumbar surgeries. ESs with endoscopic spinal surgery are on par with those found with open laminectomy and microsurgical decompression. CLINICAL RELEVANCE: This article is a meta-analysis on the benefit overlap between lumbar endoscopy, microsurgical decompression, laminectomy, and lumbar decompression fusion.

A Differential Clinical Benefit Examination of Full Lumbar Endoscopy vs Interspinous Process Spacers in the Treatment of Spinal Stenosis: An Effect Size Meta-Analysis of Clinical Outcomes.

STUDY DESIGN: A design-agnostic standardized effect meta-analysis of 48 randomized, prospective, and retrospective studies on clinical outcomes with spinal endoscopic and interspinous process spacer (IPS) surgery. OBJECTIVE: The study aimed to provide reference set of Oswestry Disability Index (ODI) and visual analog scale (VAS) effect size data for back and leg pain following endoscopic and IPS decompression for lumbar herniated disc, foraminal, or lateral recess spinal stenosis. BACKGROUND: Mechanical low back pain following endoscopic transforaminal decompression may be more reliably reduced by simultaneous posterior column stabilization with IPS. METHODS: A systematic search of the PubMed, EMBASE, Web of Science, and the Cochrane Central Register of Controlled Trials from 1 January 2000 to 2 April 2020, identified 880 eligible endoscopy and 362 IPS studies varying in design and metrics. The authors compared calculated standardized effect sizes (Cohen's d) for extracted ODI, VAS-back, and VAS-leg data. RESULTS: The pooled standardized effect size combining the ODI, VAS-back, and VAS-leg data for the total sample of 19862 data sets from the 30 endoscopy and 18 IPS was 0.877 (95% CI = 0.857-0.898). When stratified by surgery, the combined effect sizes were 0.877 (95% CI = 0.849-0.905) for endoscopic decompression and 0.863 (95% CI = 0.796-0.930; P = 0.056) for IPS implantation. The ODI effect sizes calculated on 6462 samples with directly visualized endoscopic decompression were 0.917 (95% CI = 0.891-0.943) versus 0.798 (95% CI = 0.713-0.883; P < 0.001) with indirect IPS decompression (P < 0.001). The VAS-back effect sizes calculated on 3672 samples were 0.661 (95% CI = 0.585-0.738) for endoscopy and 0.784 (95% CI: 0.644-0.923; P = 0.187) for IPS. The VAS-leg effect sizes calculated on 7890 samples were 0.885 (95% CI = 0.852-0.917) for endoscopic decompression and 0.851 (95% CI = 0.767-0.935; P = 0.427). CONCLUSION: Lumbar IPS implantation produces larger reduction in low back pain than spinal endoscopy. On the basis of this meta-analysis, the combination of lumbar transforaminal endoscopy with simultaneous IPS has merits and should be formally investigated in higher grade clinical studies. CLINICAL RELEVANCE: Meta-analysis on the added clinical benefit of combining lumbar endoscopic decompression with an interspinous process spacer.

El papel de la publicación tradicional de pruebas clínicas en la era de las modernas plataformas mediáticas / Theroleoftraditionalpublishingofclinicalevidenceintheageofmodernsocialmediaplatforms

Las redes sociales han revolucionado el uso de Internet. Según el Informe Digital de Estadísticas Globales de abril de 2022, hay unos 4.650 millones de usuarios de redes sociales en todo el mundo. 1 Este número equivale al 58,7 % de la población mundial, muchos de los cuales utilizan las redes sociales como principal fuente de información. ), youtube (2,2 mil millones), WhatsApp (2 mil millones), Instagram (2 mil millones), TikTok (1 mil millones), Snapchat (538 millones ), Pinterest (444 millones), Reddit (430 millones), Linkedin (250 millones) y Twitter (217 millones). Los cirujanos que están subiendo de rango son usuarios ávidos de las plataformas modernas de redes sociales o, al menos, son conscientes de ellos.

Socialmediahaverevolutionizedtheuseoftheinternet.Accord-ingtotheDigital2022AprilGlobalStatshotReport,therearesome4.65billionsocialmediausersworldwide.1Thisnumberistheequivalentto58.7%oftheglobalpopulation,manyofwhomareusingsocialmediaasaprimarysourceofinformation.Accordingtotheactiveusernumbers,themostpopularsocialmediaplatformsin2022areFacebook(2.9billion),youtube(2.2billion),WhatsApp(2billion),Instagram(2billion),TikTok(1billion),Snapchat(538million),Pinterest(444million),Reddit(430million),Linkedin(250million),andTwitter(217million).1SocialmediaisnotjustaU.S.phenomenonwhere84%ofAmericanshaveatleastoneoftheabove-listedsocialmediaaccounts.Thereareover1billionsocialmediausersinChina,despite415millionofitscitizenshavingnointernetaccess.1Mostyoungergenerationsoforthopedicsur-geonscominguptheranksareeitheravidusersofmodernsocialmediaplatformsorareatleastawareofthem

Rompiendo el efecto ''techo de cristal'' en la generación de evidencia clínica de alto nivel en ortopedia y traumatología / Breaking the "glass ceiling" effect in the generation of high-level clinical evidence in orthopedics and traumatology

Introduction: In clinical studies involving common orthopedic problems and traumatic injuries, randomization methods are difficult to orchestrate. The lack of high-level clinical evidence based on prospective, randomized, double-blind studies is often cited as a major reason for rejecting proposed therapeutic advances in orthopedic surgery. Materials and methods: This opinion document summarizes the limitations of clinical trials in surgical subspecialties. A consensus is presented about how the practicing orthopedic surgeon can produce high-quality clinical evidence and thus make changes to their clinical practice protocols. Results: This literature review revealed that level of evidence classifications vary among surgical subspecialties. Research in orthopedics and traumatology is primarily directed toward diagnosis, preferred treatment, and economic decision analysis, while other prognostic classifications are preferred in other areas, such as plastic surgery. In orthopedics, double-blind controlled studies are rare and often impractical or even unethical. Crossover between randomized surgical trials of study groups is more common. Other difficulties in surgical trials range from: lack of organizational and financial support, institutional approval or ethics committee and registration requirements for clinical trials, and to insufficient time outside of an already busy clinical program to dedicate to this laborious task. uncompensated task. Conclusion: Orthopedic surgery is a subspecialty based on experience and skill. Many innovations begin with enterprising surgeons reporting opinion reports or retrospective cohort studies, many of which are biased. Prospective observational cohort studies with consistent results may offer higher grade clinical evidence than poorly executed randomized trials.

Dural Tears During Lumbar Spinal Endoscopy: Surgeon Skill, Training, Incidence, Risk Factors, and Management.

BACKGROUND: Incidental dural tears during lumbar endoscopy can be challenging to manage. There is limited literature on their appropriate management, risk factors, and the clinical consequences of this typically uncommon complication. MATERIALS AND METHODS: To improve the statistical power of studying durotomy with lumbar endoscopy, we performed a retrospective survey study among endoscopic spine surgeons by email and chat groups on social media networks, including WhatsApp and WeChat. Descriptive and correlative statistics were done on the surgeons' recorded responses to multiple-choice questions. Surgeons were asked about their clinical experience with spinal endoscopy, training background, the types of lumbar endoscopic decompression they perform by approach, the decompression instruments they use, and incidental durotomy incidence with routine lumbar endoscopy. RESULTS: There were 689 dural tears in 64 470 lumbar endoscopies, resulting in an incidental durotomy incidence of 1.07%. Seventy percent of the durotomies were reported by 20.4% of the surgeons. Eliminating these 19 outlier surgeons yielded an adjusted durotomy rate of 0.32. Endoscopic stenosis decompression (54.8%; P < .0001), rather than endoscopic discectomy (44.1%; 41/93), was significantly more associated with durotomy. Medium-sized dural tears (1-10 mm) were the most common (52.2%; 48/93). Small pinhole durotomies (less than 1 mm) were the second most common type (46.7%; 43/93). Rootlet herniations were seen by 46.2% (43/93) of responding surgeons. The posterior dural sac injury during the interlaminar approach (57%; 53/93) occurred more frequently than traversing nerve-root injuries (31.2%) or anterior dural sac (23.7%; 22/93). Exiting nerve-root injuries (10.8%;10/93) were less common. Over half of surgeons did not attempt any repair or closure (52.2%; 47/90). Forty percent (36/90) used sealants. Only 7.8% (7/90) of surgeons attempted an endoscopic repair or sutures (11.1%; 10/90). DuralSeal was the most commonly used brand of commercially available sealant used (42.7%; 35/82). However, other sealants such as Tisseal (15.9%; 13/82), Evicel (2.4%2/82), and additional no-brand sealants (38; 32/82) were also used. Nearly half of the patients (48.3%; 43/89) were treated with 24-48 hours of bed rest. The majority of participating surgeons (64%; 57/89) reported that the long-term outcome was unaffected. Only 18% of surgeons reported having seen the development of a postoperative cerebrospinal fluid (CSF)-fistula (18%;16/89). However, the absolute incidence of CSF fistula was only 0.025% (16/64 470). Severe radiculopathy with dysesthesia; sensory loss; and motor weakness in association with an incidental durotomy were reported by 12.4% (11/89), 3.4% (3/89), and 2.2% (2/89) of surgeons, respectively. CONCLUSIONS: The incidence of dural tears with lumbar endoscopy is about 1%. The incidence of durotomy is higher with the use of power drills and the interlaminar approach. Stenosis decompression that typically requires the more aggressive use of these power instruments has a slightly higher incidence of dural tears than does endoscopic decompression for a herniated disc. Most dural tears are small and can be successfully managed with mechanical compression with Gelfoam and sealants. Two-thirds of patients with incidental dural tears had an entirely uneventful postoperative course. The remaining one-third of patients may develop a persistent CSF leak, radiculopathy with dysesthesia, sensory loss, or motor function loss. Patients should be educated preoperatively and reassured. LEVEL OF EVIDENCE: 3.

Durability of Endoscopes Used During Routine Lumbar Endoscopy: An Analysis of Use Patterns, Common Failure Modes, Impact on Patient Care, and Contingency Plans.

BACKGROUND: Successful implementation of endoscopic spinal surgery programs hinges on reliable performance and case cost similar to traditional decompression surgeries of the lumbar spine. MATERIALS AND METHODS: To improve the statistical power of studying the durability of endoscopes with routine lumbar endoscopy, the authors performed a retrospective survey study among endoscopic spine surgeons by email and chat groups on social media networks WhatsApp and WeChat. Descriptive and correlative statistics were done on the surgeon's responses recorded in multiple-choice questions. Surgeons were asked about their clinical experience with spinal endoscopy, training background, the types of lumbar endoscopic decompression they perform by approach, their preferred decompression instruments, and their experience with endoscopic equipment failure. RESULTS: A total of 485 surgeons responded, of whom 85 submitted a valid survey recording, rendering a completion rate of 27.1%. These 85 respondents reported a case volume of 12,650 lumbar endoscopies within the past year and, to date, had performed a total of 120,150 spinal endoscopies over their collective career years. The majority of respondents performed endoscopic surgery for herniated disc (65.9%) vs spinal stenosis (34.1%) in a hospital setting, preferentially employing the transforaminal (76.5%), interlaminar (51.8%), and unilateral biportal endoscopic (UBE; 15.3%) approach technique. The most commonly used endoscopic spine systems were Wolf/Riwo Spine (38.8%), Joimax (36.5%), Storz (24.7%), unspecified Chinese brand (22.4%), Maxmore (15.3%), Spinendos (12.9%), Elliquence (10.6%), unspecified Korean brand (7.1%), and asap Endosystems GmbH (2.4%). The most frequent failure mode of the endoscope reported by survey respondents was a blurry image (71.8%), followed by the loss of focus (21.2%), the loss of illumination of the surgical site (18.8%), and the failure of the irrigation/suction system integrated into the endoscope (4.7%). Most respondents thought they had problems with the lens (67.1%), the fiberglass light conductor (23.5%), the prism (16.5%), or the rod system (4.7%). Motorized high-speed power burrs and hand reamers and trephines were the reported favorite decompression tools that were presumably associated with the endoscope's failure. The majority of respondents (49.5%) performed up to 50 endoscopies before the endoscope had to be either exchanged or repaired. Another 15.3% of respondents reported their endoscope lasted between 101 and 200 cases and only 12.9% reported more than 300 cases. Besides abuse during surgery (25.9%), bad handling by staff was the most common suspected reason (45.9%), followed by the wrong sterilization technique (21.2%). Some 23.5% of respondents noted that the endoscope failed during their surgery. In that case, 66.3% asked for a replacement endoscope, and 36.1% completed the surgery with the broken endoscope. However, 10.8% stopped and another 6% of respondents woke the patient up and rescheduled the surgery to complete the decompression at another time. CONCLUSIONS: Spinal endoscopes used during routine lumbar decompression surgeries for herniated disc and spinal stenosis have an estimated life cycle between 50 and 100 surgeries. Abusive use by surgeons, mishandling by staff, and deviation for prescribed cleaning and sterilization protocols may substantially shorten the life cycle. Contingency protocols should be in place to readily replace a broken spinal endoscope during surgery. More comprehensive implementation of endoscopic spine surgery techniques will hinge on technology advancements to make these hightech surgical instruments more resistant to the stress of daily use and abuse of expanded clinical indications' for surgery. The regulatory burden on endoscope makers is likely to increase, calling for increased reimbursement for facilities to cover the added expense for capital equipment purchase, disposables, and the endoscopic spine surgery program's maintenance. LEVEL OF EVIDENCE: 3. CLINICAL RELEVANCE: End user surgeon survey study.

Feasibility of Deep Learning Algorithms for Reporting in Routine Spine Magnetic Resonance Imaging.

BACKGROUND: Artificial intelligence is gaining traction in automated medical imaging analysis. Development of more accurate magnetic resonance imaging (MRI) predictors of successful clinical outcomes is necessary to better define indications for surgery, improve clinical outcomes with targeted minimally invasive and endoscopic procedures, and realize cost savings by avoiding more invasive spine care. OBJECTIVE: To demonstrate the ability for deep learning neural network models to identify features in MRI DICOM datasets that represent varying intensities or severities of common spinal pathologies and injuries and to demonstrate the feasibility of generating automated verbal MRI reports comparable to those produced by reading radiologists. METHODS: A 3-dimensional (3D) anatomical model of the lumbar spine was fitted to each of the patient's MRIs by a team of technicians. MRI T1, T2, sagittal, axial, and transverse reconstruction image series were used to train segmentation models by the intersection of the 3D model through these image sequences. Class definitions were extracted from the radiologist report for the central canal: (0) no disc bulge/protrusion/canal stenosis, (1) disc bulge without canal stenosis, (2) disc bulge resulting in canal stenosis, and (3) disc herniation/protrusion/extrusion resulting in canal stenosis. Both the left and right neural foramina were assessed with either (0) neural foraminal stenosis absent, or (1) neural foramina stenosis present. Reporting criteria for the pathologies at each disc level and, when available, the grading of severity were extracted, and a natural language processing model was used to generate a verbal and written report. These data were then used to train a set of very deep convolutional neural network models, optimizing for minimal binary cross-entropy for each classification. RESULTS: The initial prediction validation of the implemented deep learning algorithm was done on 20% of the dataset, which was not used for artificial intelligence training. Of the 17,800 total disc locations for which MRI images and radiology reports were available, 14,720 were used to train the model, and 3560 were used to validate against. The convergence of validation accuracy achieved with the deep learning algorithm for the foraminal stenosis detector was 81% (sensitivity = 72.4.4%, specificity = 83.1%) after 25 complete iterations through the entire training dataset (epoch). The accuracy was 86.2% (sensitivity = 91.1%, specificity = 82.5%) for the central stenosis detector and 85.2% (sensitivity = 81.8%, specificity = 87.4%) for the disc herniation detector. CONCLUSIONS: Deep learning algorithms may be used for routine reporting in spine MRI. There was a minimal disparity among accuracy, sensitivity, and specificity, indicating that the data were not overfitted to the training set. We concluded that variability in the training data tends to reduce overfitting and overtraining as the deep neural network models learn to focus on the common pathologies. Future studies should demonstrate the accuracy of deep neural network models and the predictive value of favorable clinical outcomes with intervention and surgery. LEVEL OF EVIDENCE: 3. CLINICAL RELEVANCE: Feasibility, clinical teaching, and evaluation study.

Artificial Intelligence Comparison of the Radiologist Report With Endoscopic Predictors of Successful Transforaminal Decompression for Painful Conditions of the Lumber Spine: Application of Deep Learning Algorithm Interpretation of Routine Lumbar Magnetic Resonance Imaging Scan.

BACKGROUND: Identifying pain generators in multilevel lumbar degenerative disc disease is not trivial but is crucial for lasting symptom relief with the targeted endoscopic spinal decompression surgery. Artificial intelligence (AI) applications of deep learning neural networks to the analysis of routine lumbar MRI scans could help the primary care and endoscopic specialist physician to compare the radiologist's report with a review of endoscopic clinical outcomes. OBJECTIVE: To analyze and compare the probability of predicting successful outcome with lumbar spinal endoscopy by using the radiologist's MRI grading and interpretation of the radiologic image with a novel AI deep learning neural network (Multus Radbot™) as independent prognosticators. METHODS: The location and severity of foraminal stenosis were analyzed using comparative ordinal grading by the radiologist, and a contiguous grading by the AI network in patients suffering from lateral recess and foraminal stenosis due to lumbar herniated disc. The compressive pathology definitions were extracted from the radiologist lumbar MRI reports from 65 patients with a total of 383 levels for the central canal - (0) no disc bulge/protrusion/canal stenosis, (1) disc bulge without canal stenosis, (2) disc bulge resulting in canal stenosis, and (3) disc herniation/protrusion/extrusion resulting in canal stenosis. Both neural foramina were assessed with either - (0) neural foraminal stenosis absent, or (1) neural foramina are stenosis present. Reporting criteria for the pathologies at each disc level and, when available, the grading of severity were extracted and assigned into two categories: "Normal," and "Stenosis." Clinical outcomes were graded using dichotomized modified Macnab criteria considering Excellent and Good results as "Improved," and Fair and Poor outcomes as "Not Improved." Binary logistic regression analysis was used to predict the probability of the AI- and radiologist grading of stenosis at the 88 foraminal decompression sites to result in "Improved" outcomes. RESULTS: The average age of the 65 patients was 62.7 +/- 12.7 years. They consisted of 51 (54.3%) males and 43 (45.7%) females. At an average final follow-up of 57.4 +/- 12.57, Macnab outcome analysis showed that 86.4% of the 88 foraminal decompressions resulted in Excellent and Good (Improved) clinical outcomes. The stenosis grading by the radiologist showed an average severity score of 4.71 +/- 2.626, and the average AI severity grading was 5.65 +/- 3.73. Logit regression probability analysis of the two independent prognosticators showed that both the grading by the radiologist (86.2%; odds ratio 1.264) and the AI grading (86.4%; odds ratio 1.267) were nearly equally predictive of a successful outcome with the endoscopic decompression. CONCLUSIONS: Deep learning algorithms are capable of identifying lumbar foraminal compression due to herniated disc. The treatment outcome was correlated to the decompression of the directly visualized corresponding pathology during the lumbar endoscopy. This research should be extended to other validated pain generators in the lumbar spine. LEVEL OF EVIDENCE: 3. CLINICAL RELEVANCE: Validity, clinical teaching, evaluation study.

Reliability Analysis of Deep Learning Algorithms for Reporting of Routine Lumbar MRI Scans.

BACKGROUND: Artificial intelligence could provide more accurate magnetic resonance imaging (MRI) predictors of successful clinical outcomes in targeted spine care. OBJECTIVE: To analyze the level of agreement between lumbar MRI reports created by a deep learning neural network (RadBot) and the radiologists' MRI reading. METHODS: The compressive pathology definitions were extracted from the radiologist lumbar MRI reports from 65 patients with a total of 383 levels for the central canal: (0) no disc bulge/protrusion/canal stenosis, (1) disc bulge without canal stenosis, (2) disc bulge resulting in canal stenosis, and (3) disc herniation/protrusion/extrusion resulting in canal stenosis. For both, neural foramina were assessed with either (0) neural foraminal stenosis absent or (1) neural foramina stenosis present. Reporting criteria for the pathologies at each disc level and, when available, the grading of severity were extracted, and the Natural Language Processing model was used to generate a verbal and written report. The RadBot report was analyzed similarly as the MRI report by the radiologist. MRI reports were investigated by dichotomizing the data into 2 categories: normal and stenosis. The quality of the RadBot test was assessed by determining its sensitivity, specificity, and positive and negative predictive value as well as its reliability with the calculation of the Cronbach alpha and Cohen kappa using the radiologist MRI report as a gold standard. RESULTS: The authors found a RadBot sensitivity of 73.3%, a specificity of 88.4%, a positive predictive value of 80.3%, and a negative predictive value of 83.7%. The reliability analysis revealed the Cronbach alpha as 0.772. The highest individual values of the Cronbach alpha were 0.629 and 0.681 when compared to the MRI report by the radiologist, rending values of 0.566 and 0.688, respectively. Analysis of interobserver reliability rendered an overall kappa for the RadBot of 0.627. Analysis of receiver operating characteristics (ROC) showed a value of 0.808 for the area under the ROC curve. CONCLUSIONS: Deep learning algorithms, when used for routine reporting in lumbar spine MRI, showed excellent quality as a diagnostic test that can distinguish the presence of neural element compression (stenosis) at a statistically significant level (P < .0001) from a random event distribution. This research should be extended to validated and directly visualized pain generators to improve the accuracy and prognostic value of the routine lumbar MRI scan for favorable clinical outcomes with intervention and surgery. LEVEL OF EVIDENCE: 3. CLINICAL RELEVANCE: Validity, clinical teaching, and evaluation study.

Transforaminal Endoscopic Discectomy Combined With an Interspinous Process Distraction System for Spinal Stenosis.

BACKGROUND: The combination of the percutaneous transforaminal endoscopic decompression (PTED) with an interspinous process distraction system (IPS) may offer additional benefit in the treatment of spinal stenosis in patients who have failed nonsurgical treatment. METHODS: We retrospectively reviewed the medical records of 33 patients diagnosed with lumbar stenosis and radiculopathy and treated them with transforaminal endoscopic lumbar decompression between 2013 and 2017. Primary outcome measures were modified Macnab as well as preoperative and postoperative visual analog scale (VAS) criteria and the Oswestry Disability Index (ODI). Only patients with a minimum follow-up of 2 years were included. RESULTS: A total of 28 patients were treated with a combination of PTED and percutaneous IPS (group A), and 5 patients were treated with PTED and mini-open IPS (group B). In group A patients, there was a 4.48 reduction in the VAS score. The ODI changed from 50.25 preoperatively to 18.2 postoperatively, and excellent and good Macnab outcomes were obtained in 78% of patients. In group B patients, the mean VAS reduction was 5.2 points. The ODI changed from 44.34 preoperatively to 14.62 postoperatively, and 80% of group B patients achieved excellent and good Macnab outcomes. No complications related to PTED or IPS were observed throughout the 2-year follow-up. CONCLUSIONS: The addition of IPS to the PTED procedure in select patients may offer additional benefits to patients being treated for lumbar lateral stenosis and foraminal stenosis with low-grade spondylolisthesis. LEVEL OF EVIDENCE: 3. CLINICAL RELEVANCE: Feasibility study.

Feasibility of Using Intraoperative Neuromonitoring in the Prophylaxis of Dysesthesia in Transforaminal Endoscopic Discectomies of the Lumbar Spine.

(1) Background: Postoperative nerve root injury with dysesthesia is the most frequent sequela following lumbar endoscopic transforaminal discectomy. At times, it may be accompanied by transient and rarely by permanent motor weakness. The authors hypothesized that direct compression of the exiting nerve root and its dorsal root ganglion (DRG) by manipulating the working cannula or endoscopic instruments may play a role. (2) Objective: To assess whether intraoperative neurophysiological monitoring can help prevent nerve root injury by identifying neurophysiological events during the initial placement of the endoscopic working cannula and the directly visualized video endoscopic procedure. (3) Methods: The authors performed a retrospective chart review of 65 (35 female and 30 male) patients who underwent transforaminal endoscopic decompression for failed non-operative treatment of lumbar disc herniation from 2012 to 2020. The patients' age ranged from 22 to 86 years, with an average of 51.75 years. Patients in the experimental group (32 patients) had intraoperative neurophysiological monitoring recordings using sensory evoked (SSEP), and transcranial motor evoked potentials (TCEP), those in the control group (32 patients) did not. The SSEP and TCMEP data were analyzed and correlated to the postoperative course, including dysesthesia and clinical outcomes using modified Macnab criteria, Oswestry disability index (ODI), visual analog scale (VAS) for leg and back pain. (4) Results: The surgical levels were L4/L5 in 44.6%, L5/S1 in 23.1%, and L3/L4 in 9.2%. Of the 65 patients, 56.9% (37/65) had surgery on the left, 36.9% (24/65) on the right, and the remaining 6.2% (4/65) underwent bilateral decompression. Postoperative dysesthesia occurred in 2 patients in the experimental and six patients in the control group. In the experimental neuromonitoring group, there was electrodiagnostic evidence of compression of the exiting nerve root's DRG in 24 (72.7%) of the 32 patients after initial transforaminal placement of the working cannula. A 5% or more decrease and a 50% or more decrease in amplitude of SSEPs and TCEPs recordings of the exiting nerve root were resolved by repositioning the working cannula or by pausing the root manipulation until recovery to baseline, which typically occurred within an average of 1.15 min. In 15 of the 24 patients with such latency and amplitude changes, a foraminoplasty was performed before advancing the endoscopic working cannula via the transforaminal approach into the neuroforamen to avoid an impeding nerve root injury and postoperative dysesthesia. (5) Conclusion: Neuromonitoring enabled the intraoperative diagnosis of DRG compression during the initial transforaminal placement of the endoscopic working cannula. Future studies with more statistical power will have to investigate whether employing neuromonitoring to avoid intraoperative compression of the exiting nerve root is predictive of lower postoperative dysesthesia rates in patients undergoing videoendoscopic transforaminal discectomy.