Polytomous Rasch Analyses of Surgeons' Decision-Making on Choice of Procedure in Endoscopic Lumbar Spinal Stenosis Decompression Surgeries.

BACKGROUND: With the growing prevalence of lumbar spinal stenosis, endoscopic surgery, which incorporates techniques such as transforaminal, interlaminar, and unilateral biportal (UBE) endoscopy, is increasingly considered. However, the patient selection criteria are debated among spine surgeons. OBJECTIVE: This study used a polytomous Rasch analysis to evaluate the factors influencing surgeon decision-making in selecting patients for endoscopic surgical treatment of lumbar spinal stenosis. METHODS: A comprehensive survey was distributed to a representative sample of 296 spine surgeons. Questions encompassed various patient-related and clinical factors, and responses were captured on a logit scale graphically displaying person-item maps and category probability curves for each test item. Using a Rasch analysis, the data were subsequently analyzed to determine the latent traits influencing decision-making. RESULTS: The Rasch analysis revealed that surgeons' preferences for transforaminal, interlaminar, and UBE techniques were easily influenced by comfort level and experience with the endoscopic procedure and patient-related factors. Harder-to-agree items included technological aspects, favorable clinical outcomes, and postoperative functional recovery and rehabilitation. Descriptive statistics suggested interlaminar as the best endoscopic spinal stenosis decompression technique. However, logit person-item analysis integral to the Rasch methodology showed highest intensity for transforaminal followed by interlaminar endoscopic lumbar stenosis decompression. The UBE technique was the hardest to agree on with a disordered person-item analysis and thresholds in category probability curve plots. CONCLUSION: Surgeon decision-making in selecting patients for endoscopic surgery for lumbar spinal stenosis is multifaceted. While the framework of clinical guidelines remains paramount, on-the-ground experience-based factors significantly influence surgeons' selection of patients for endoscopic lumbar spinal stenosis surgeries. The Rasch methodology allows for a more granular psychometric evaluation of surgeon decision-making and accounts better for years-long experience that may be lost in standardized clinical guideline development. This new approach to assessing spine surgeons' thought processes may improve the implementation of evidence-based protocol change dictated by technological advances was endorsed by the Interamerican Society for Minimally Invasive Spine Surgery (SICCMI), the International Society for Minimal Intervention in Spinal Surgery (ISMISS), the Mexican Spine Society (AMCICO), the Brazilian Spine Society (SBC), the Society for Minimally Invasive Spine Surgery (SMISS), the Korean Minimally Invasive Spine Society (KOMISS), and the International Society for the Advancement of Spine Surgery (ISASS).

Comparative Analysis of Learning Curve, Complexity, Psychological Stress, and Work Relative Value Units for CPT 62380 Endoscopic Lumbar Spinal Decompression vs Traditional Lumbar Spine Surgeries: A Paired Rasch Survey Study.

BACKGROUND: Effective 1 January 2017, single-level endoscopic lumbar discectomy received a Category I Current Procedural Terminology (CPT) code 62380. However, no work relative value units (RVUs) are currently assigned to the procedure. An international team of endoscopic spine surgeons conducted a study, endorsed by several spine societies, analyzing the learning curve, difficulty, psychological intensity, and estimated work RVUs of endoscopic lumbar spinal decompression compared with other common lumbar spine surgeries. METHODS: A survey comparing CPT 62380 to 10 other comparator CPT codes reflective of common spine surgeries was developed to assess the work RVUs in terms of learning curve, difficulty, psychological intensity, and work effort using a paired Rasch method. RESULTS: The survey was sent to 542 spine specialists. Of 322 respondents, 150 completed the survey for a 43.1% completion rate. Rasch analysis of the submitted responses statistically corroborated common knowledge that the learning curve with lumbar endoscopic spinal surgery is steeper and more complex than with traditional translaminar lumbar decompression surgeries. It also showed that the psychological stress and mental and work effort with the lumbar endoscopic decompression surgery were perceived to be higher by responding spine surgeons compared with posterior comparator decompression and fusion surgeries and even posterior interbody and posterolateral fusion surgeries. The regression analysis of work effort vs procedural difficulty showed the real-world evaluation of the lumbar endoscopic decompression surgery described in CPT code 62380 with a calculated work RVU of 18.2464. CONCLUSION: The Rasch analysis suggested the valuation for the endoscopic lumbar decompression surgery should be higher than for standard lumbar surgeries: 111.1% of the laminectomy with exploration and/or decompression of spinal cord and/or cauda equina (CPT 63005), 118.71% of the laminectomy code (CPT 63047), which includes foraminotomy and facetectomy, 152.1% of the hemilaminectomy code (CPT 63030), and 259.55% of the interlaminar or interspinous process stabilization/distraction without decompression code (CPT 22869). This research methodology was endorsed by the Interamerican Society for Minimally Invasive Spine Surgery (SICCMI), the Mexican Society of Spinal Surgeons (AMCICO), the International Society For Minimally Invasive Spine Surgery (ISMISS), the Brazilian Spine Society (SBC), the Society for Minimally Invasive Spine Surgery (SMISS), the Korean Minimally Invasive Spine Surgery (KOMISS), and the International Society for the Advancement of Spine Surgery (ISASS). CLINICAL RELEVANCE: This study provides an updated reimbursement recommendation for endoscopic spine surgery. LEVEL OF EVIDENCE: Level 3.

Randomized Clinical Trials and Observational Tribulations: Providing Clinical Evidence for Personalized Surgical Pain Management Care Models.

Proving clinical superiority of personalized care models in interventional and surgical pain management is challenging. The apparent difficulties may arise from the inability to standardize complex surgical procedures that often involve multiple steps. Ensuring the surgery is performed the same way every time is nearly impossible. Confounding factors, such as the variability of the patient population and selection bias regarding comorbidities and anatomical variations are also difficult to control for. Small sample sizes in study groups comparing iterations of a surgical protocol may amplify bias. It is essentially impossible to conceal the surgical treatment from the surgeon and the operating team. Restrictive inclusion and exclusion criteria may distort the study population to no longer reflect patients seen in daily practice. Hindsight bias is introduced by the inability to effectively blind patient group allocation, which affects clinical result interpretation, particularly if the outcome is already known to the investigators when the outcome analysis is performed (often a long time after the intervention). Randomization is equally problematic, as many patients want to avoid being randomly assigned to a study group, particularly if they perceive their surgeon to be unsure of which treatment will likely render the best clinical outcome for them. Ethical concerns may also exist if the study involves additional and unnecessary risks. Lastly, surgical trials are costly, especially if the tested interventions are complex and require long-term follow-up to assess their benefit. Traditional clinical testing of personalized surgical pain management treatments may be more challenging because individualized solutions tailored to each patient's pain generator can vary extensively. However, high-grade evidence is needed to prompt a protocol change and break with traditional image-based criteria for treatment. In this article, the authors review issues in surgical trials and offer practical solutions.

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.

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.

Pain Relief After Allogenic Stem Cell Disc Therapy.

BACKGROUND: Treatment of intermediate-stage painful degenerative disc disease is controversial, with few reliable options. Allogenic mesenchymal stem cells (MSCs)are an alternative to autologous stem cell transplantation. Allogeneic MSCs in the treatment of discogenic low back pain have some practical advantages, ranging from availability to ease of treatment in a procedure-room setting. OBJECTIVES: To assess the efficacy and safety of allogenic MSC injection into painful lumbar intervertebral discs and associated clinical outcomes. STUDY DESIGN: Retrospective observational cohort study. SETTING: Private practice. METHODS: There were 33 patients: 15 women and 18 men with an average age of 47.6 years. The patients' average follow-up was 26.88 months Patients were treated with intradiscal injection of approximately 5 million allogeneic polyclonal MSCs in 1% hyaluronic acid derived from immunoselected umbilical cord stem cells. Patients were monitored for adverse event reactions. Clinical outcomes were assessed with reductions in the reported Visual Analog Scale (VAS) for back pain, the Oswestry Disability Index (ODI) scores, and the use of the modified Macnab criteria. RESULTS: No patient required any additional treatments for low back pain stemming from the level treated with MSC injections. At a 2-year follow-up, the average VAS low back score reduction was 6.565 ± 1.619 and 38.333 ± 14.865 for the ODI (P < 0.001). Reported Macnab outcomes were excellent in 11 patients (33.3%), good in 19 (57.6%), and fair in 3 (9.1%). LIMITATIONS: Our observational study is limited by patient selection, hindsight bias, and low patient numbers. CONCLUSION: The results of our feasibility study suggest that the injection of allogeneic MSCs to treat patients with painful intermediate-stage degenerative disc disease has merit. No adverse reactions were observed. The authors recommend further study in a randomized prospective study setting with a placebo control group or a natural history study group of patients to solidify this research.

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.

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.

Surgery for lumbar disc herniation: open x minimally invasive technique / Cirurgia de hérnia discal lombar: técnica aberta x minimamente invasiva / Cirugía de hernia discal lumbar: técnica abierta x mínimamente invasiva

ABSTRACT Objective: In Brazil, there are no studies comparing endoscopic treatment of lumbar disc herniation with the conventional open technique in SUS (Unified Health System) with regard to hospitalization time and complications occurring within one year, which is the objective of this study. Methods: A survey of 32 surgeries performed in 2019 (11 open and 21 endoscopic) to evaluate pain parameters before and after surgery (VAS), days of hospitalization, and complications. The data were submitted to statistical analysis (ANOVA) using the Kruskal-Wallis test. Results: Fourteen patients were female and eighteen were male, with a mean age of 41.35 years (p> 0.05 between sexes). The pre- and postoperative VAS for pain radiating to the lower limb were similar between the groups: 8.5 ± 0.82 with the open technique and 8.19 ± 1.15 with endoscopic technique. In both groups there was an improvement in the pain pattern with a significant reduction in the VAS (p < 0.05) and there was no statistical relevance between the groups in terms of pain improvement. There was statistical relevance between the groups in the comparison of days of hospitalization required, with the group submitted to endoscopic surgery having a lower number of days. The complications reported were compatible with those found in the literature (postoperative dysesthesia, new herniation). Conclusions: The endoscopic technique resulted in an important reduction in the number of days of hospitalization, a factor with a high impact on the costs of any surgical procedure, which can be a determining factor in the feasibility of minimally invasive techniques. Level of evidence IV; Therapeutic Study.

RESUMO Objetivos: No Brasil, não há estudos que comparem o tratamento endoscópico de hérnia de disco lombar no SUS (Sistema Único de Saúde) com a técnica aberta convencional, no que diz respeito aos resultados com relação ao tempo de internação e complicações ocorridas em um ano, o que vem a ser o objetivo deste estudo. Métodos: Levantamento de 32 cirurgias realizadas em 2019 (11 por via aberta e 21 por via endoscópica) para avaliar os parâmetros de dor antes e depois da cirurgia (EVA), dias de internação e complicações. Os dados foram submetidos à análise estatística (ANOVA) com o teste de Kruskal-Wallis. Resultados: Catorze pacientes eram do sexo feminino e 18 do sexo masculino, com média de idade de 41,35 anos (p > 0,05 para os dois sexos). A EVA de dor irradiada para o membro inferior no pré e pós-operatório foi semelhante entre os grupos: 8,5 ± 0,82 com a técnica aberta e 8,19 ± 1,15 com a técnica endoscópica. Em ambos os grupos houve melhora do padrão de dor com redução significativa da EVA (p < 0,05) e não houve relevância estatística entre os grupos quanto à melhora do dor. Na comparação das diárias de internação necessárias houve relevância estatística entre os grupos, sendo que o grupo submetido à endoscopia teve número menor de diárias. As complicações relatadas são compatíveis com as encontradas na literatura (disestesia pós-operatória, nova herniação). Conclusões: A técnica endoscópica resultou em redução importante do número de dias de internação, fator com alto impacto nos custos de qualquer procedimento cirúrgico, que pode ser determinante para viabilizar técnicas minimamente invasivas. Nível de evidência IV; Estudo Terapêutico.

RESUMEN Objetivos: En Brasil, no hay estudios que comparen el tratamiento endoscópico de hernia de disco lumbar en el SUS (Sistema Único de Salud) con la técnica abierta convencional, en lo que refiere a los resultados con relación al tiempo de internación y complicaciones ocurridas en un año, lo que viene a ser el objetivo de este estudio. Métodos: Levantamiento de 32 cirugías realizadas en 2019 (once por vía abierta y veintiuna por vía endoscópica) para evaluar los parámetros de dolor antes y después de la cirugía (EVA), días de internación y complicaciones. Los datos fueron sometidos a análisis estadístico (ANOVA) con el test de Kruskal-Wallis. Resultados: Catorce pacientes eran del sexo femenino y dieciocho del sexo masculino con promedio de edad de 41,35 años (p>0,05 para los dos sexos). La EVA de dolor irradiado para el miembro inferior en el pre y postoperatorio fue semejante entre los grupos: 8,5±0,82 con la técnica abierta y 8,19±1,15 con la técnica endoscópica. En ambos grupos hubo mejoras del patrón de dolor con reducción significativa de la EVA (p<0,05) y no hubo relevancia estadística entre los grupos cuanto a la mejora del dolor. En la comparación de los días de internación necesarios hubo relevancia estadística entre los grupos, siendo que el grupo sometido a la endoscopia tuvo número menor de días de internación. Las complicaciones relatadas son compatibles con las encontradas en la literatura (disestesia postoperatoria, nueva herniación). Conclusiones: La técnica endoscópica resultó en reducción importante del número de días de internación, factor con alto impacto en los costos de cualquier procedimiento quirúrgico, que puede ser determinante para viabilizar técnicas mínimamente invasivas. Nivel de evidencia IV; Estudio Terapéutico.

Indication and Contraindication of Endoscopic Transforaminal Lumbar Decompression.

BACKGROUND: The indications and contraindications to the endoscopic transforaminal approach for lumbar spinal stenosis are not well defined. METHODS: We performed a Kaplan-Meier durability survival analysis of patients with the following types of spinal stenosis: type I, central canal; type II, lateral recess; type III, foraminal; and type IV, extraforaminal. The 304 patients comprised 140 men and 164 women, with an average age of 51.68 ± 15.78 years. The average follow-up was 45.3 years (range, 18-90 years). The primary clinical outcome measures were the Oswestry Disability Index, visual analog scale, and the modified Macnab criteria. RESULTS: Of 304 study patients, 70 had type I (23.0%) stenosis, 42 type II (13.7%), 151 type III (49.7%), and 41 type IV (13.5%). Excellent outcomes were obtained in 114 patients (37.5%), good in 152 (50.0%), fair in 33 (10.9%), and poor in 5 (1.6%). Kaplan-Meier durability analysis of the clinical treatment benefit with the endoscopic transforaminal decompression surgery showed statistically significance differences (P < 0.0001) on log-rank (Mantel-Cox) χ2 testing between the estimated median (50% percentile) survival times of type I (28 months), type II (53 months), type III (32 months), and type IV (66 months). CONCLUSIONS: We recommend stratifying patients based on the underlying compressive disease and the skill level of the endoscopic spine surgeon to decide preoperatively whether more difficult central or complex foraminal stenotic lesions should be considered for alternative endoscopic approaches.

Endoscopic Transforaminal Lumbar Interbody Fusion With a Single Oblique PEEK Cage and Posterior Supplemental Fixation.

BACKGROUND: To demonstrate the feasibility of an endoscopically assisted minimally invasive surgery transforaminal lumbar interbody fusion (MIS-TLIF) and to study clinical outcomes with the use of a static oblique bullet-shaped cannulated poly-ether-ether-ketone (PEEK) lumbar interbody fusion cage in conjunction with platelet enriched plasma infused allograft cancellous chips and posterior supplemental fixation. METHODS: In this retrospective study of 43 patients who underwent endoscopically assisted MIS-TLIF for spondylolisthesis (53.5%) and stenosis (46.3%), the Oswestry Disability Index, the visual analog scale (VAS) for back and leg pain, and the modified Macnab criteria were used as primary clinical outcome measures. Clinical outcomes were cross-tabulated against fusion grade using the Bridwell classification of interbody fusion. RESULTS: The majority of patients (90.7%) had excellent (8/43; 18.6%) and good (31/43; 72.1%) Macnab outcomes. There were significant VAS back score reductions from an average preoperative values of 8.9070 to a postoperative VAS score of 3.8605, and a score of 2.7674 at final follow-up (P < .0001). The reductions in the VAS leg scores were also significant from preoperative score of 5.58 to a postoperative value of 2.16, and a final follow-up score of 1.67 (P < .0001); the Oswestry Disability Index score went from a preoperative value of 54.4 to 23.3 postoperatively and 18.5 at the final follow-up (P < .0001). The vast majority of patients (92.9%) with Bridwell grade I fusion had excellent and good Macnab outcomes (P = .027). CONCLUSIONS: The authors recommend the use of an endoscope as an adjunct to MIS-TLIF, a minimally invasive spinal surgery technique in which many surgeons may be well versed and have a great deal of experience. Clinical outcomes with the endoscopic interbody fusion procedure with a static PEEK cage in conjunction with platelet-enriched bone allograft were favorable. LEVEL OF EVIDENCE: 3. CLINICAL RELEVANCE: Feasibility study.

Dysethesia due to irritation of the dorsal root ganglion following lumbar transforaminal endoscopy: Analysis of frequency and contributing factors.

BACKGROUND: New onset of acute dysethetic leg pain due to irritation of the dorsal root ganglion (DRG) following uneventful recovery from an expertly executed lumbar transforaminal endoscopic decompression is a common problem. Its incidence and relation to any risk factors that could be mitigated preoperatively are not well understood. METHODS: We performed a multicenter frequency analysis of DRG irritation dysesthesia in 451 patients who underwent lumbar transforaminal endoscopic decompression for herniated disc and foraminal stenosis. The 451 patients consisted of 250 men and 201 women with an average age of 55.77 ± 15.6 years. The average follow-up of 47.16 months. The primary clinical outcome measures were the modified Macnab criteria. Chi-square testing was employed to analyze statistically significant associations between increased dysesthesia rates, preoperative diagnosis, the surgical level(s), and surgeon technique. RESULTS: At final follow-up, Excellent (183/451; 40.6 %) and Good (195/451; 43.2 %) Macnab outcomes were observed in the majority of patients (378/451; 83.8 %). The majority of study patients (354; 78.5 %) had an entirely uneventful postoperative recovery without any DRG irritation, but 21.5 % of patients were treated for it in the immediate postoperative recovery period with supportive care measures including activity modification, transforaminal epidural steroid injections, non-steroidal anti-inflammatories, gabapentin, or pregabalin. There was no statistically significant difference in dysesthesia rates between lumbar levels from L1 to S1, or between single (DRG rate 21.8 %) or two-level (DRG rate 20.2 %) endoscopic decompression (p = 0.742). A statistically significantly higher incidence of postoperative dysesthesia was observed in patients who underwent decompression for foraminal stenosis (38/103; 27 %), and recurrent herniated disc (7/10; 41.2 %; p = 0.039). There were also statistically significant variations in dysesthesia rates between the seven participating clinical study sites ranging from 11.6%-33% (p = 0.002). Unrelenting postoperative dysesthetic leg pain due to DRG irritation was statistically associated with less favorable long-term clinical outcomes with DRG rates as high as 45 % in patients with a Fair and 61.3 % in patients with Poor Macnab outcomes (p < 0.0001). CONCLUSIONS: Postoperative dysesthesia following transforaminal endoscopic decompression should be expected in one-fifth of patients. There was no predilection for any lumbar level. Foraminal stenosis and recurrent herniated disc surgery are risk factors for higher dysesthesia rates. There was a statistically significant variation of dysesthesia rates between participating centers suggesting that the surgeon skill level is of significance. Severe postoperative dysesthesia may be a predictor of Fair of Poor long-term Macnab outcomes.

Transforaminal endoscopic decompression and uninstrumented allograft lumbar interbody fusion: A feasibility study in patients with end-stage vacuum degenerative disc disease.

OBJECTIVE: The authors investigated the feasibility of a transforaminal endoscopic decompression and un-instrumented lumbar interbody fusion procedures with cancellous bone allograft in patients painful with end-stage degenerative vacuum disc disease. PATIENTS & METHODS: Twenty-nine patients who underwent endoscopic transforaminal foraminal and lateral recess decompression and direct intraoperative endoscopic visualization of a painful, hollow collapsed, rigid intervertebral disc space were grafted with cancellous allograft chips. In addition to the radiographic assessment of fusion, patients were followed for a minimum of 2 years postoperatively, and clinical outcomes were evaluated with VAS, ODI, and modified MacNab criteria. RESULTS: At the final follow, mean VAS and ODI scores reduced from 7.34 ± 1.63 and 50.03 ± 10.64 preoperatively to 1.62 ± 1.741 and 6.69 ± 4.294 postoperatively (p < 0.0001). Excellent and Good clinical outcomes, according to Macnab criteria, were obtained in 34.5 % and 62.1 % of patients, respectively. Only one patient had minimal improvement from "Poor" preoperatively to "Fair" postoperatively. This female patient was treated for lumbar disc herniation L5/S1 and had an incomplete fusion at the final follow up. Computed tomography assessment of interbody fusion at the last follow-up showed successful fusion in 91.4 % of patients. CONCLUSIONS: Un-instrumented interbody fusion by packing a hollow interspace with cancellous bone allograft chips can be considered as an adjunct to endoscopic foraminal and lateral recess decompression in select patients with validated painful, collapsed, and rigid motion segments. It can be safely done in an outpatient setting at a low burden to patients.

Patient selection protocols for endoscopic transforaminal, interlaminar, and translaminar decompression of lumbar spinal stenosis.

BACKGROUND: The indications of different endoscopic and endoscopically assisted translaminar approaches for lumbar spinal stenosis are not well-defined, and validated protocols for the use of the transforaminal over the interlaminar approach are lacking. METHODS: We performed a retrospective study employing an image-based patient stratification protocol of stenosis location (type I-central canal, type II-lateral recess, type III-foraminal, type IV-extraforaminal) and clinical outcomes on 249 patients consisting of 137 (55%) men and 112 (45%) women with an average age of 56.03±16.8 years who underwent endoscopic surgery for symptomatic spinal stenosis from January 2013 to February 2019. The average follow-up of 38.27±27.9 months. The primary clinical outcome measures were the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS), and modified Macnab criteria. RESULTS: The frequency of stenosis configuration in decreasing order was as follows: type I-121/249; 48.6%, type III-104/249; 41.8%, type II-15/249; 6%, and type IV-9/249; 3.6%. The transforaminal approach (137/249; 55.0%) was used in most type II to IV lesions followed by the interlaminar approach (78/249; 31.3%), and the full endoscopic approach (12/249; 4.8%), and the endoscopically assisted translaminar approach (8/249; 3.2%) which was exclusively used for type I lesions. Macnab outcomes analysis showed Excellent in 47 patients (18.9%), Good in 178 (71.5%), Fair in 18 (7.2%) and Poor in 6 (2.4%), respectively. Paired two-tailed t-test showed statistically significant VAS (5.46±2.1; P<0.0001) and ODI (37.1±16.9; P<0.0001) reductions as a result of the endoscopic decompression surgery. Cross-tabulation of the Macnab outcomes versus the endoscopic approach and surgical technique confirmed beneficial association of the approach selection with Excellent (P=0.001) and Good (P<0.0001) outcomes with statistically significance. CONCLUSIONS: This study suggests that in the hands of skilled endoscopic spines surgeon use of an image-based stenosis location protocol may contribute to obtaining Excellent and Good clinical outcomes in a high percentage (93%) of patients suffering from lumbar stenosis related radiculopathy. Additional comparative studies should examine the prognostic value of choosing the endoscopic approach on the basis of the proposed four-type stenosis protocol by correlating its impact on outcomes with preoperative diagnostic injections and intraoperative direct visualization of symptomatic pain generators under local anesthesia and sedation.

Surgeon training and clinical implementation of spinal endoscopy in routine practice: results of a global survey.

BACKGROUND: Training of spine surgeons may impact the availability of contemporary minimally invasive spinal surgery (MIS) to patients and drive spine surgeons' clinical decision-making when applying minimally invasive spinal surgery techniques (MISST) to the treatment of common degenerative conditions of the lumbar spine. Training requirements and implementation of privileges vary in different parts of the world. The purpose of this study was to analyze the training in relation to practice patterns of surgeons who perform lumbar endoscopic spinal surgery the world over. METHODS: The authors solicited responses to an online survey sent to spine surgeons by email, and chat groups in social media networks including Facebook, WeChat, WhatsApp, and Linkedin. Surgeons were asked the following questions: (I) please indicate your training? (II) What type of MISST spinal surgery do you perform? (III) How would you rate your experience in MIS lumbar spinal surgery and what percentage of your practice is MISST? And (IV) which avenue did you use to train for the MISST you currently employ in your clinical practice today? Descriptive statistics were applied to count responses and cross-tabulated them to the surgeon's training. Pearson Chi-square measures, kappa statistics, and linear regression analysis of agreement or disagreement were performed by analyzing the distribution of variances using statistical package SPSS version 25.0. RESULTS: A total of 430 surgeons accessed the survey. The completion rate was 67.4%. Analyzing the responses of 292 surveys submitted by 97 neurosurgeons (33.2%), 161 orthopaedic surgeons (55.1%), and 34 surgeons of other postgraduate training (11.6%) showed that only 14% (41/292) of surgeons had completed a fellowship. Surgeons rated their skill level 33.5% of the time as master and experienced surgeon, and 35.6% of the time as novice or surgeon with some experience. There were more master (64.6% versus 29.2%) and experienced (52% versus 40%) surgeons amongst orthopaedic surgeons than amongst neurosurgeons at a statistically significant level (P=0.11). There were near twice as many orthopaedic surgeons (54.3%) using endoscopic procedures in the lumbar spine as their favorite MISST than neurosurgeons (35.4%; P=0.096). Endoscopic spine surgeons' main sources of knowledge acquisition were (I) learning in small meetings (57.3%), (II) attending workshops (63.1%), and (III) national and international conferences (59.8%). CONCLUSIONS: The majority of spine surgeons reported more than half of their cases employing MISST at a high skill level. Very few MISST surgeons are fellowship trained but attend workshops and various meetings suggesting that many of them are self-thought. Orthopaedic surgeons were more likely to implement endoscopic spinal surgery into the routine clinical practice. As endoscopic spine surgery gains more traction and patient demand, minimal adequate training will be part of the ongoing debate.