Indication For Spine Surgery Research Articles

Five-Year Longitudinal Follow-Up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction

BackgroundAdults with refractory, mechanical chronic low back pain associated with impaired neuromuscular control of the lumbar multifidus muscle have few treatment options that provide long-term clinical benefit. This study hypothesized that restorative neurostimulation, a rehabilitative treatment that activates the lumbar multifidus muscles to overcome underlying dysfunction, is safe and provides relevant and durable clinical benefit to patients with this specific etiology. Materials and MethodsIn this prospective five-year longitudinal follow-up of the ReActiv8-B pivotal trial, participants (N = 204) had activity-limiting, moderate-to-severe, refractory, mechanical chronic low back pain, a positive prone instability test result indicating impaired multifidus muscle control, and no indications for spine surgery. Low back pain intensity (10-cm visual analog scale [VAS]), disability (Oswestry Disability Index), and quality of life (EuroQol’s “EQ-5D-5L” index) were compared with baseline and following the intent-to-treat principle, with a supporting mixed-effects model for repeated measures that accounted for missing data. ResultsAt five years (n = 126), low back pain VAS had improved from 7.3 to 2.4 cm (−4.9; 95% CI, −5.3 to −4.5 cm; p < 0.0001), and 71.8% of participants had a reduction of ≥50%. The Oswestry Disability Index improved from 39.1 to 16.5 (−22.7; 95% CI, −25.4 to −20.8; p < 0.0001), and 61.1% of participants had reduction of ≥20 points. The EQ-5D-5L index improved from 0.585 to 0.807 (0.231; 95% CI, 0.195–0.267; p < 0.0001). Although the mixed-effects model attenuated completed-case results, conclusions and statistical significance were maintained. Of 52 subjects who were on opioids at baseline and had a five-year visit, 46% discontinued, and 23% decreased intake. The safety profile compared favorably with neurostimulator treatments for other types of back pain. No lead migrations were observed. ConclusionOver a five-year period, restorative neurostimulation provided clinically substantial and durable benefits with a favorable safety profile in patients with refractory chronic low back pain associated with multifidus muscle dysfunction. Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is NCT02577354; registration date: October 15, 2016; principal investigator: Christopher Gilligan, MD, Brigham and Women’s Hospital, Boston, MA, USA. The study was conducted in Australia (Broadmeadow, New South Wales; Noosa Heads, Queensland; Welland, South Australia; Clayton, Victoria), Belgium (Sint-Niklaas; Wilrijk), The Netherlands (Rotterdam), UK (Leeds, London, Middlesbrough), and USA (La Jolla, CA; Santa Monica, CA; Aurora, CO; Carmel, IN; Indianapolis, IN; Kansas City, KS; Boston, MA; Royal Oak, MI; Durham, NC; Winston-Salem, NC; Cleveland, OH; Providence, RI; Spartanburg, SC; Spokane, WA; Charleston, WV).

Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction

BackgroundRestorative neurostimulation is a rehabilitative treatment for patients with refractory chronic low back pain (CLBP) associated with dysfunction of the lumbar multifidus muscle resulting in impaired neuromuscular control. The ReActiv8-B randomized, sham-controlled trial provided evidence of the effectiveness and safety of an implanted, restorative neurostimulator. The two-year analysis previously published in this journal demonstrated accrual of clinical benefits and long-term durability. ObjectiveEvaluation of three-year effectiveness and safety in patients with refractory, disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. Materials and MethodsProspective, observational follow-up of the 204 implanted trial participants. Low back pain visual analog scale (VAS), Oswestry Disability Index (ODI), EuroQol quality of life survey, and opioid intake were assessed at baseline, six months, and one, two, and three years after activation. The mixed-effects model repeated measures approach was used to provide implicit imputations of missing data for continuous outcomes and multiple imputation for proportion estimates. ResultsData were collected from 133 participants, and 16 patients missed their three-year follow-up because of coronavirus disease restrictions but remain available for future follow-up. A total of 62% of participants had a ≥ 70% VAS reduction, and 67% reported CLBP resolution (VAS ≤ 2.5cm); 63% had a reduction in ODI of ≥ 20 points; 83% had improvements of ≥ 50% in VAS and/or ≥ 20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 71% (36/51) participants on opioids at baseline had voluntarily discontinued (49%) or reduced (22%) opioid intake. The attenuation of effectiveness in the imputed (N = 204) analyses was relatively small and did not affect the statistical significance and clinical relevance of these results. The safety profile remains favorable, and no lead migrations have been observed to date. ConclusionAt three years, 83% of participants experienced clinically substantial improvements in pain, disability, or both. The results confirm the long-term effectiveness, durability, and safety of restorative neurostimulation in patients with disabling CLBP associated with multifidus muscle dysfunction. Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is NCT02577354.

Indication for spinal surgery: associated factors and regional differences in Germany

BackgroundRising surgery rates have raised questions about the indications for spinal surgery. The study investigated patient-level and regional factors associated with spinal surgery for patients with spinal diseases.MethodsWe undertook a cohort study based on routine healthcare data from Germany of 18.4 million patients within 60.9 million episodes of two patient-years before a possible spinal surgery in the time period 2008 to 2016. Using a Poisson model, the effects of a broad range of patient-related (sociodemographic, morbidity, social status), disease- and healthcare-related (physicians’ specialty, conservative treatments) and regional variables were analyzed.ResultsThere was substantial regional heterogeneity in the occurrence of spinal surgery which decreased by only one quarter when controlling for the various determinants assessed. Previous musculoskeletal and mental health disorders as well as physical therapy were associated with a lower probability of surgery in the fully-adjusted model. Prescriptions for pain medication and consultations of specialists were associated with a higher probability of surgery. However, the specific severity of the vertebral diseases could not be taken into account in the analysis. Furthermore, a substantial proportion of patients with surgery did not receive a consultation with an outpatient specialist (29.5%), preoperative diagnostics (37.0%) or physical therapy (48.3%) before hospital admission.ConclusionThis large study on spinal diseases in Germany highlights important patterns in medical care of spinal diseases and their association with the probability of spinal surgery. However, only a relatively small proportion of the regional heterogeneity in spinal surgery could be explained by the extensive consideration of confounders, which suggests the relevance of other unmeasured factors like physicians’ preferences.

The effectiveness of percutaneous endoscopic decompression compared with open decompression and fusion for lumbar spinal stenosis: protocol for a multicenter, prospective, cohort study

BackgroundLumbar spinal stenosis (LSS) is one of the most frequent indications for spine surgery. Open decompression and fusion surgery was the most common treatment and used to be regarded as the golden standard treatment for LSS. In recent years, percutaneous endoscopic decompression surgery was also used for LSS. However, the effectiveness and safety of percutaneous endoscopic decompression in the treatment of LSS have not been supported by high-level evidence. Our aim is to 1) compare the effectiveness of percutaneous endoscopic decompression surgery and open decompression and fusion for the treatment of LSS. 2) Investigate the prognosis risk factors for LSS. 3) Evaluate the influence of percutaneous endoscopic decompression for the stability of operative level, and degeneration of adjacent level.MethodsIt’s a prospective, multicenter cohort study. The study is performed at 4 centers in Beijing. This study plans to enroll 600 LSS patients (300 patients in the percutaneous endoscopic decompression group, and 300 patients in the open decompression and fusion group). The demographic variables, healthcare variables, symptom related variables, clinical assessment (Visual analogue score (VAS), Oswestry disability index (ODI), Japanese Orthopaedic Association score (JOA)), and radiological assessment (dynamic X-ray, CT, MRI) will be collected at baseline visit. Patients will follow up at 3, 6, 12 months. The primary outcome is the difference of improvement of ODI between baseline and 12-month follow-up between the two groups. The secondary outcome is the score changes of preoperative and postoperative VAS, the recovery rate of JOA, MacNab criteria, patient satisfaction, degeneration grade of adjacent level, ROM of operative level and adjacent level, complication rate.DiscussionIn this study, we propose to conduct a prospective registry study to address the major controversies of LSS decompression under percutaneous spinal endoscopy, and investigate the clinical efficacy and safety of percutaneous endoscopic decompression and open decompression in the treatment of LSS.Trial registrationThis study has been registered on clinicaltrials.gov in January 15, 2020 (NCT04254757). (SPIRIT 2a).

Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two-Year Results of the ReActiv8-B Pivotal Trial

BackgroundImpaired neuromuscular control and degeneration of the multifidus muscle have been linked to the development of refractory chronic low back pain (CLBP). An implantable restorative-neurostimulator system can override the underlying multifidus inhibition by eliciting episodic, isolated contractions. The ReActiv8-B randomized, active-sham-controlled trial provided effectiveness and safety evidence for this system, and all participants received therapeutic stimulation from four months onward. ObjectiveThis study aimed to evaluate the two-year effectiveness of this restorative neurostimulator in patients with disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. Materials and MethodsOpen-label follow-up of 204 participants implanted with a restorative neurostimulation system (ReActiv8, Mainstay Medical, Dublin, Ireland) was performed. Pain intensity (visual analog scale [VAS]), disability (Oswestry disability index [ODI]), quality-of-life (EQ-5D-5L), and opioid intake were assessed at baseline, six months, one year, and two years after activation. ResultsAt two years (n = 156), the proportion of participants with ≥50% CLBP relief was 71%, and 65% reported CLBP resolution (VAS ≤ 2.5 cm); 61% had a reduction in ODI of ≥20 points, 76% had improvements of ≥50% in VAS and/or ≥20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 87% of participants had continued device use during the second year for a median of 43% of the maximum duration, and 60% (34 of 57) had voluntarily discontinued (39%) or reduced (21%) opioid intake. ConclusionsAt two years, 76% of participants experienced substantial, clinically meaningful improvements in pain, disability, or both. These results provide evidence of long-term effectiveness and durability of restorative neurostimulation in patients with disabling CLBP, secondary to multifidus muscle dysfunction. Clinical Trial RegistrationThe study is registered on clinicaltrials.gov with identifier NCT02577354.

P78. Socioeconomic and community disparities in presenting physical functionality and mental distress characteristics of patients undergoing spine surgery

<h3>BACKGROUND CONTEXT</h3> Timeliness of care, providers' ability to identify and treat a problem, is one of the Institute of Medicine's six key priorities. When timeliness is compromised, patients experience greater distress and incur higher treatment expenses. Black patients and low-income patients are more likely to never get care when compared to their White and high-income counterparts. <h3>PURPOSE</h3> To examine the effect of socioeconomic disparities on functional and mental health impairment upon indication for spine surgery. To discern the impact of presenting physical impairment on 90D postop, patient reported outcomes. <h3>STUDY DESIGN/SETTING</h3> This prospective study was conducted within the University of Pennsylvania Health System (UPHS), a tertiary care, referral center. <h3>PATIENT SAMPLE</h3> Inclusion criteria included patients (N=855) who were 18 years or older and visited a clinician within UPHS for spinal surgery between November 1, 2018 and August 1, 2019. Patients must have had a self-reported, Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) score, a PROMIS Global Mental Health (GPH) score, and a Visual Analog Scale (VAS) pain score at the time of presentation as well as PROMIS GPH and GMH scores at 90D postop. <h3>OUTCOME MEASURES</h3> (1-3) Preop VAS pain score; PROMIS GPH score; PROMIS GMH score; (4-5) 90D postop PROMIS GPH, GMH scores. <h3>METHODS</h3> Higher PROMIS scores indicate a better, health-related quality of life/functionality and higher VAS scores indicate greater subjective pain. Chi Square analysis, one-way analysis of variance (ANOVA), and Kruskal-Wallis analyses were utilized as appropriate with Bonferroni's and Dunn's post-hoc tests for multiple comparisons. A multivariable linear regression model was constructed to quantify the degree to which a patient's presenting PROMIS Global Physical Health (GPH) score was related to clinical predictors. <h3>RESULTS</h3> The cohort was stratified into socioeconomic (SES) quartiles based on the median household income of a patient's zip code. The highest SES White patients had mental health PROMIS scores that were 21.4% higher, or improved, when compared to the lowest SES White patients (P<0.0001), and the highest SES Black/African-American patients had median mental health PROMIS scores that were 30% higher than the lowest SES Black/African-American patients (P=0.0049). When compared to the highest quartile of PROMIS GPH Scores (GPH =14+), patients who reported GPH scores in the lowest quartile (Score= 1-8), resided in communities where the median household income was 26% lower (P<0.0001) and had 10.7% higher population per primary care provider (P=0.0031). Additionally, at 90D postop, patients who reported initial GPH scores in the lowest quartile reported postop GMH scores that were 36.8%(P<0.0001) worse and GPH(P<0.0001) scores 37.5% worse when compared to highest quartile of presenting PROMIS GPH Scores (GPH =14+). Black/African-American Race (B = -1.011, P=0.012), lower access to health care within a zip code (B = -1.616, P<0.0001), and low SES patients (B = -1.504, P=0.001) were independent drivers of worsened presenting PROMIS GPH Scores. <h3>CONCLUSIONS</h3> Our findings endorse the notion that Black/African-American patients and socioeconomically disadvantaged patients may present with more severe baseline pathology due, in part, to structural barriers such as inadequate access to care which in turn, adversely affect their postoperative trajectories. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

P68. Racial disparities in presenting physical functionality and mental distress characteristics of patients undergoing spine surgery

<h3>BACKGROUND CONTEXT</h3> When considering severity of presentation, patient-reported outcomes (PROs) have become increasingly emphasized in orthopedic surgery as surrogates for quality of care. Additionally, PROs provide insight into the severity of an illness or injury and its impact on a patient's life and may also be predictors of treatment outcomes and patient satisfaction. The literature suggests that Black and other minority patients undergoing spine surgery are more likely to present with lower baseline PROs (bodily pain, physical functioning), worse symptom severity, and greater pain compared to white patients. <h3>PURPOSE</h3> To examine racial disparities in functional and mental health impairment, measured by PROMIS scores for mental health and physical impairment, upon indication for spine surgery. <h3>STUDY DESIGN/SETTING</h3> Retrospective Chart Review of patient reported scores on presentation for spinal surgery. <h3>PATIENT SAMPLE</h3> Patients between November 2018 and August 2019 who received 1-2 segment cervical decompression and fusion, 1-2 segment cervical or thoracic laminotomy, 1-2 segment lumbar laminotomy, 1-2 level lumbar interbody fusion, or arthrodesis to correct long, spinal deformity but limited to 8 segments or fewer. <h3>OUTCOME MEASURES</h3> Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) score, a PROMIS Global Mental Health (GPH) score, and a Visual Analog Scale (VAS) pain score at the time of presentation. <h3>METHODS</h3> Chi Square analysis, one-way analysis of variance (ANOVA), and Kruskal-Wallis analyses were used to determine if race, socioeconomic status of a patient's community, and procedure type had an effect on the degree of physical impairment, overall pain, or mental distress of a presenting patient. Bonferroni-corrected post hoc t tests and Dunn's post hoc nonparametric test for multiple comparisons were conducted after obtaining significant ANOVA, or Kruskal-Wallis results, respectively. <h3>RESULTS</h3> The overall study sample predominantly self-identified as racially White (73.5%), and males comprised 49.8% of the total cohort. At the time of presentation for spine surgery, patients presented with an average Visual Analog Scale (VAS) pain score of 5.84 (95% C.I: 5.66-6.03), a median PROMIS mental health score of 12 (IQR: 9-15), and a median PROMIS physical health score of 11 (IQR: 8-13). Notably, there was no difference in the presenting pain score by the Visual Analog Scale among patients who underwent the five different procedures (PANOVA = 0.9749) When compared to White patients undergoing the same procedure, Black/African-American patients had median VAS pain scores that were 16.7% higher, indicating greater pain, among those undergoing cervical decompression and fusion (P= 0.047) as well as lumbar interbody fusion (P=0.0167). Black/African-American patients had median VAS pain scores that were 60% higher among those undergoing cervical/thoracic laminotomy (P=0.0005), lumbar laminotomy (P<0.0001), and arthrodesis for spinal deformity (P=0.0012) when compared to White patients undergoing the same procedure. Additionally, Black/African-American patients had lower median PROMIS mental scores among those undergoing cervical/thoracic laminotomy (P=0.0012), lumbar laminotomy (P=0.0195), and lumbar interbody fusion (P=0.0208). Black/African-American patients had lower median PROMIS physical scores among those undergoing cervical decompression and fusion (P=0.0028), cervical or thoracic laminotomy (P=0.0024), lumbar laminotomy (P<0.0001), lumbar interbody fusion (P=0.0100), and arthrodesis to correct long, spinal deformity (P=0.0261). <h3>CONCLUSIONS</h3> These findings suggest that racial disparities exist in patients' presentation for spine surgery. Likely causes include disparities in household income, characteristics of a patient's neighborhood, and a patient's access to health care. Our findings refute any notions or misconceptions held by both medical professionals and laypersons that Black/African-American patients are more immune to pain and impairment when compared to White patients. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Durability of the Therapeutic Effect of Restorative Neurostimulation for Refractory Chronic Low Back Pain

ObjectivesThe purpose of the ongoing follow‐up of ReActiv8‐A clinical trial is to document the longitudinal benefits of episodic stimulation of the dorsal ramus medial branch and consequent contraction of the lumbar multifidus in patients with refractory mechanical chronic low back pain (CLBP). We report the four‐year outcomes of this trial.Materials and MethodsReActiv8‐A is a prospective, single‐arm trial performed at nine sites in the United Kingdom, Belgium, and Australia. Eligible patients had disabling CLBP (low back pain Numeric Rating Scale [NRS] ≥6; Oswestry Disability Index [ODI] ≥25), no indications for spine surgery or spinal cord stimulation, and failed conventional management including at least physical therapy and medications for low back pain. Fourteen days postimplantation, stimulation parameters were programmed to elicit strong, smooth contractions of the multifidus, and participants were given instructions to activate the device for 30‐min stimulation‐sessions twice daily. Annual follow‐up through four years included collection of NRS, ODI, and European Quality of Life Score on Five Dimensions (EQ‐5D). Background on mechanisms, trial design, and one‐year outcomes were previously described.ResultsAt baseline (N = 53) (mean ± SD) age was 44 ± 10 years; duration of back pain was 14 ± 11 years, NRS was 6.8 ± 0.8, ODI 44.9 ± 10.1, and EQ‐5D 0.434 ± 0.185. Mean improvements from baseline were statistically significant (p < 0.001) and clinically meaningful for all follow‐ups. Patients completing year 4 follow‐up, reported mean (±standard error of the mean) NRS: 3.2 ± 0.4, ODI: 23.0 ± 3.2, and EQ‐5D: 0.721 ± 0.035. Moreover, 73% of participants had a clinically meaningful improvement of ≥2 points on NRS, 76% of ≥10 points on ODI, and 62.5% had a clinically meaningful improvement in both NRS and ODI and 97% were (very) satisfied with treatment.ConclusionsIn participants with disabling intractable CLBP who receive long‐term restorative neurostimulation, treatment satisfaction remains high and improvements in pain, disability, and quality‐of‐life are clinically meaningful and durable through four years.

176. Thoracolumbar interfascial plane (TLIP) block and intrathecal fentanyl injection results in an opioid-free peri- and postoperative recovery and early ambulation after percutaneous lumbar spine surgery

BACKGROUND CONTEXT Open lumbar spine fusion surgery usually requires opioid analgesia for several weeks during the postoperative recovery period. Recently, a facet-sparing, full percutaneous transforaminal lumbar interbody fusion (TLIF) has been introduced that uses an endoscopic cannula for placement of an interbody cage in combination with percutaneous transpedicular screws and rods. The Thoraco-Lumbar Interfascial Plain (TLIP) block is a novel, ultrasound-guided local anesthesia technique that targets the sensory component of the dorsal rami of the thoracolumbar nerves. PURPOSE We aim to evaluate the efficacy in avoiding post-operative opioid analgesics and allowing early patient ambulation of a novel inter-disciplinary, spine surgery protocol that combines a perioperative TLIP block, intrathecal fentanyl injection and percutaneous TLIF spine surgery. STUDY DESIGN/SETTING Prospective, nonrandomized sequential case series study. PATIENT SAMPLE A total of 15 consecutive patients underwent TLIP combined with percutaneous TLIF spine surgery between 2018 and 2019. Indication for spine surgery was degenerative disk disease of the lumbar spine with or without spondylolisthesis up to grade 2 and foraminal stenosis. OUTCOME MEASURES Pre- and postoperative visual analogic scale (VAS) for lumbar back and leg pain were quantitatively assessed (range 0 to 10) immediately, at 6 and at 12 hours after surgery and at time of hospital discharge. Oswestry Disability Index (ODI) scores (range 0 to 50) were assessed preoperatively and at time of hospital discharge. The time of first post-operative patient ambulation was registered. Significance between pre- and postoperative scores were analyzed with student's paired t-test. METHODS Intrathecal fentanyl 25 mcgr was administered to the patient in sitting position and ultrasound-guided bilateral TLIP was performed in prone position with bupivacaine 0.25% and dexamethasone 8mgrs (20ml each side) by the anesthesia team. All patients were operated on under general anesthesia (protocol: propofol 2.0-3.0 mcg/ml (TCI) following BIS, ketamine 0.15 mg/Kg/h, rocuronium 0.4 mg/Kg). Percutaneous TLIF was performed by inserting an expandable interbody implant using the facet-sparing, trans-Kambin approach with an endoscopic cannula and complemented with a percutaneous posterior fixation consisting of transpedicular screws and rods. Postoperative analgesia included NSAIDs, acetaminophen and a manually patient-controlled oral sublingual 15 mcgr sufentanil microtablet analgesic system (Zalviso®), while its use was monitored. RESULTS Fifteen patients with a mean age of 64.1 years (range, 34 to 82 years) were evaluated. A median of two levels (range, 1 to 4 levels) per patient were instrumented and a median of one interbody cage (range, 1 to 2 cages) was placed in the lumbar spine. No intravenous fentanyl administration was necessary during surgery. The median time of surgery was 3.5 hours. Mean preoperative VAS scores for lumbar back and leg pain were 6.3 and 5.8, respectively. Mean postoperative VAS back scores at 0h, 6h, 12h and at discharge improved to 1.2, 1.8, 2.4 and 2.7 (P CONCLUSIONS The combination of perioperative TLIP, intrathecal fentanyl injection and percutaneous TLIF surgery prevents peri- and postoperative opioid administration and improves the quality of peri- and postoperative analgesia, allowing early patient ambulation and fast hospital discharge. This interdisciplinary analgesia protocol is a promising solution to avoid opioid analgesia in spine surgery and could be particularly interesting in the context of an outpatient spine surgery setting. FDA DEVICE/DRUG STATUS Fentanyl (Approved for this indication), Zalviso (Approved for this indication), Bupivacaine (Approved for this indication), Globus RISE (Approved for this indication)

Improvement in functional gait parameters following corrective thoracolumbar surgery in children affected by Mucopolysaccharidosis 1 (Hurler syndrome)

ObjectiveThoracolumbar kyphosis is a common indication for spinal surgery in children with Mucopolysaccharidosis. Functional outcome of spinal surgical intervention has never been published in patients with this rare disease. We present a cohort of patients with Mucopolysaccharidosis 1(Hurler syndrome) who underwent thoraco-lumbar spinal deformity correction and functional outcome assessed by pre-operative and post-operative gait analysis. This study represents the first attempt at presenting a functional assessment of surgical outcome in any Mucopolysaccharidosis subtype.MethodsA retrospective analysis of prospectively collected data was carried out from 11 children diagnosed with this subtype of Mucopolysaccharidosis. All patients underwent thoracolumbar kyphosis correction between the years 2013 to 2016. Gait assessment was performed using GAITRite™ electronic walkway pre-operatively and post-operatively within 9 to 24 months from the index surgery. Walking distance, cadence and gait velocity were the three spatio-temporal parameters analysed. Wilcoxon signed rank test was used to analyse the data and P-Value ≤0.05 was deemed significant.ResultsThere was a statistically significant improvement in walking distance in 9 out of 11 patient post-operatively with a mean increase of 232.06 cms (P = 0.05). There was marginal improvement in cadence by 6.33 steps/min post-operatively (P-value 0.79). Gait velocity also showed a marginal increase by 8.73 cms/sec post-operatively (P-value 0.32).ConclusionThe results of our study suggest that correction of thoracolumbar kyphosis in children with Mucopolysaccharidosis 1 resulted in a significant improvement of walking distance with a trend towards improved gait in the other parameters. Post-operative change in cadence was not statistically significant suggesting that physiological maturation of gait had minimal effect in the specified post-operative assessment timeframe. This study emphasizes that outcomes of spinal surgery in children with Mucopolysaccharidosis 1 should be determined by functional measures aiming to maintain or improve quality of life.

Psychological factors outmatched morphological markers in predicting limitations in activities of daily living and participation in patients with lumbar stenosis

BackgroundRecent demographic changes have led to a large population of older adults, many of whom experience degenerative disc diseases. Degenerative lumbar spinal stenosis (DLSS) is associated with considerable discomfort and limitations in activities of daily living (ADL). Symptomatic DLSS is one of the most frequent indications for spinal surgery. The aim of this study was to identify sociodemographic variables, morphological markers, depression as well as fear of movement that predict ADL performance and participation in social life in patients with DLSS.MethodsSixty-seven patients with DLSS (mean age 62.5 years [11.7], 50.7% females) participated in the study. Predictor variables were age, gender, duration of disease, three morphological markers (severity of the lumbar stenosis, the number of affected segments and presence of spondylolisthesis) as well as self-reported depression and fear of movement. Dependent variables were pain interference with the performance of ADLs, ADLs and participation in social life. Correlations between predictor and dependent variables were calculated before stepwise, linear regression analyses. Only significant correlations were included in the linear regression analyses.ResultsVariance explained by the predictor variables ranged between 12% (R2 = .12; pain interference-physical) and 40% (R2 = .40; ADL requiring lower extremity functioning; participation). Depression and fear of movement were the most powerful predictors for all dependent variables. Among the morphological markers only stenosis severity contributed to the prediction of ADLs requiring lower extremity functioning.ConclusionDepression and fear of movement were more important predictors of the execution of ADLs and participation in social life compared to morphological markers. Elevated depressive symptoms and fear of movement might indicate limited adaptation and coping regarding the disease and its consequences. Early monitoring of these predictors should therefore be conducted in every spine centre. Future studies should investigate whether psychological screening or a preoperative psychological consultation helps to avoid operations and enables better patient outcomes.

Managing spine surgery referrals: The consultation of neurosurgery and its nuances

IntroductionSpinal disorders, particularly low back pain, are among the most common reasons for general practitioner (GP) consultation and can sometimes be a source of professional friction. Despite their frequency and published guidelines, many patients are still mistakenly referred by their GP to specialists for spinal surgery consultation which can create colleague relationship problems, suboptimal or unnessary delayed care, as well as the financial implications for patients. PurposeTo assess the management of GP lumbar spine referrals made to 4 neurosurgeons from 3 neurosurgical teams specialized in spinal surgery. MethodsAll patient's medical records relating to 672 primary consultants over a period of two months (January and February 2015) at three institutions were retrospectively reviewed. Medical referral letters, clinical evidence and imaging data were analyzed and the patients were classified according the accuracy of surgical assessment. The final decisions of the surgeons were also considered. ResultsOf the 672 patients analyzed, 198 (29.5%) were considered unsuitable for surgical assessment: no spinal pathology=10.6%, no surgical conditions=35.4%, suboptimal medical treatment=31.3%, suboptimal radiology=18.2% and asymptomatic patients=4.5%. ConclusionUnnecessary referrals to our consultation centers highlight the gap between the reason for the consultation and the indications for spinal surgery. Compliance with the guidelines, the creation of effective multidisciplinary teams, as well as the “hands on” involvement of surgeons in primary and continuing education of physicians are the best basis for a reduction in inappropriate referrals and effective patient care management.

Targeting the cause, not just the symptoms: A new treatment for chronic low back pain – results of the ReActiv8-A trial

Introduction: For many people with chronic low back pain (CLBP), the root cause of the persistence of pain is disruption in control of the key muscles that stabilize the lumbar spine, particularly the lumbar multifidus. A feasibility study demonstrated that stimulation of the L2 medial branch to elicit episodic repetitive smooth contractions of the lumbar multifidi facilitated recovery from CLBP. Purpose: ReActiv8-A is a prospective single arm clinical trial designed to evaluate a new implantable neurostimulation stimulation system (ReActiv8® by Mainstay Medical). Materials and methods: Ten centers in Australia and Europe enrolled 92 subjects, of whom 47 proceeded to ReActiv8 implant and 46 reached the 90 day follow up. Key inclusion criteria included disabling CLBP (low back pain NRS ≥ 6) despite a minimum of 90 days of medical management including at least physical therapy and drugs, no prior spine surgery, and no indications for spine surgery or spinal cord stimulation. After the treatment activation visit, subjects were asked to administer two 30-min stimulation sessions per day for a minimum of 90 days. At baseline, average duration of CLBP was 13.8 ± 10.3 years; average age was 43.9 ± 10.7 years. The majority of subjects (70%) were regularly taking opioids at baseline, and many were taking NSAIDS. The population had attempted all or most available treatments for their CLBP. Results: At the 90 day follow up, 63% of subjects reported a ≥2 point improvement on single day NRS for average low back pain with a mean improvement of 2.3 ± 0.3 (33%) compared to baseline of 6.7 ± 0.2 (n = 46; p < 0.0001), and at 180 days it was 58% with a mean improvement of 2.1 ± 0.4 (30%) (n = 45, p < 0.0001). The proportion of subjects with a clinically important improvement in disability (≥10 point reduction in ODI) at 90 days was 57% with a mean improvement of 14.8 ± 2.3 (33%) compared to baseline of 46.4 ± 1.8 (n = 46, p < 0.0001), and at 180 days it was 60% with a mean improvement of 12.4 ± 2.4 (30%) compared to baseline of 45.2 ± 2.1 (n = 45, p < 0.0001). Conclusion: These results show that subjects with disabling CLBP implanted with ReActiv8, experienced a clinically important, statistically significant and lasting improvement in their low back pain, related disability and quality of life.

Predictive factors for homologous transfusion during paediatric scoliosis surgery

IntroductionBlood saving strategies during paediatric spinal surgery often include recombinant erythropoietin (rEPO) and antifibrinolytic therapy (AFT). The goal of this study was to investigate additional preventive factors involved in the risk of blood transfusion. MethodsThis prospective study was designed with the aim of identifying factors associated with the perioperative (defined as the intraoperative and the first postoperative day) probability of homologous red cell transfusion during scoliosis surgery in children operated during a one year period in our institution. The predictors analysed were: age, weight less than the 3rd percentile (W<3P), indication for spinal surgery (idiopathic or neuromuscular), Cobb's angle, ASA status, preoperative haemoglobin, number of levels fused, duration of surgery, intraoperative fluid intakes, sacral fusion and thoracoplasty. Statistical analyses were performed using a multivariate logistic regression model. ResultsOne hundred and forty-seven patients were included in the analysis. Multivariate analysis found the following variables to be independent predictors for an increased risk of homologous blood transfusion: W<3P, neuromuscular scoliosis and duration of surgery>255minutes. ROC analysis for the latter model found an area under the curve of 0.9 (95% confidence interval: 0.8–0.97). The accuracy of the model was 92.3% (97.4% for non-transfusion and 69.2% for transfusion). Multivariate sensitivity analysis excluding patients with no preoperative administration of EPO found similar results. ConclusionThe current results indicate that optimising nutritional status might prevent allogenic blood transfusion and requires further investigation.

Waiting for lumbar spinal stenosis surgery: Suffering, resources to cope and expectations

During recent decades, lumbar spinal stenosis (LSS) has become the most common indication for spine surgery, a change that coincides with a higher worldwide prevalence of overweight and obesity. Thus, surgical treatment of LSS in the overweight and obese population is common and increasing in scope.The overall aim of this thesis was to investigate whether body mass index (BMI) is related to the development of LSS, and whether BMI is linked to outcome after surgery for LSS. We further evaluated whether there are specific experiences of LSS from a patient perspective.Data were obtained for all patients registered in the Swedish Spine Register who had undergone surgery for LSS between January 1, 2006 and June 30, 2008. After adjusting for differences in baseline characteristics, patients with obesity showed both poorer results after surgery and a higher rate of dissatisfaction than patients with normal weight (odds ratio 1.73; 95% confidence interval, CI, 1.36-2.19).Furthermore, patients with obesity in the cohort reported modest weight loss at follow-up (2.0 kg; 95% CI, 1.5-2.4), and only 8% reported a clinical important weight loss 2 years after surgery.Our analysis of 389,132 construction workers, showed that overweight (incidence rate ratio, IRR 1.68; 95% CI, 1.54-1.83) and obesity (IRR 2.18; 95% CI, 1.87-2.53) were associated with an increased future risk in developing LSS when compared with patients with normal weight.To gain insight into the patients' perspective of LSS, we performed interviews with 18 patients who were on a waiting list for LSS surgery. The transcripts, analyzed with content analysis, revealed that living with LSS is a physical, mental and social challenge in which resources to cope with the condition are of major importance.In summary, obesity is associated with poorer results after surgery, and patients with obesity report modest weight loss during follow-up. In addition, obesity is associated with an increased risk to develop LSS. Our findings revealed that being a patient with LSS, naturally involves considerable suffering and pain, but it also implies being a person with his or her own resources who is able to cope with these adverse conditions.

Indications for Spine Surgery

Retrospective analysis of Medicare claims linked to a multicenter clinical trial. The Spine Patient Outcomes Research Trial (SPORT) provided a unique opportunity to examine the validity of a claims-based algorithm for grouping patients by surgical indication. SPORT enrolled patients for lumbar disc herniation, spinal stenosis, and degenerative spondylolisthesis. We compared the surgical indication derived from Medicare claims with that provided by SPORT surgeons, the "gold standard." Administrative data are frequently used to report procedure rates, surgical safety outcomes, and costs in the management of spinal surgery. However, the accuracy of using diagnosis codes to classify patients by surgical indication has not been examined. Medicare claims were link to beneficiaries enrolled in SPORT. The sensitivity and specificity of 3 claims-based approaches to group patients on the basis of surgical indications were examined: (1) using the first listed diagnosis; (2) using all diagnoses independently; and (3) using a diagnosis hierarchy on the basis of the support for fusion surgery. Medicare claims were obtained from 376 SPORT participants, including 21 with disc herniation, 183 with spinal stenosis, and 172 with degenerative spondylolisthesis. The hierarchical coding algorithm was the most accurate approach for classifying patients by surgical indication, with sensitivities of 76.2%, 88.1%, and 84.3% for disc herniation, spinal stenosis, and degenerative spondylolisthesis cohorts, respectively. The specificity was 98.3% for disc herniation, 83.2% for spinal stenosis, and 90.7% for degenerative spondylolisthesis. Misclassifications were primarily due to codes attributing more complex pathology to the case. Standardized approaches for using claims data to group patients accurately by surgical indications have widespread interest. We found that a hierarchical coding approach correctly classified more than 90% of spine patients into their respective SPORT cohorts. Therefore, claims data seem to be a reasonably valid approach to classifying patients by surgical indication. 3.

Patterns of spine surgeries at Mulago Hospital

Background: Spine surgery is a specialised area of orthopaedics that is still in its formative stages in Africa. It may be done to relieve symptoms, or stabilise the spine to allow rehabilitation of patients. This review analyses spine surgeries done in the period 2005-2009 in a National Referral Hospital. Objectives: Patterns of spine surgeries. Design: A retrospective review of patients who underwent spine surgeries. Setting: Mulago National Referral Hospital, Uganda. Methods: Data was collected from theatre logs and the patient files retrieved for perusal. The data was then analysed. Results: Spine surgeries have been increasing in number over the years with a marked increase in 2009. Male patients were predominantly due to trauma while females were usually due to degenerative causes. Conclusion: Trauma especially that caused by road traffic accidents needs a holistic approach to adequately manage. There is need to facilitate surgeons with training and equipment so that their output may increase. Trauma still predominates as an indication for spine surgery. Outcome may be affected by delays in referral to the spine unit. The spine surgeon is increasingly being called upon to managed degenerative and developmental conditions. East African Orthopaedic JournalVol. 4: March 2010

Is there an indication for spine surgery in the treatment of chronic back pain or deformities?

Is there an indication for spine surgery in the treatment of chronic back pain or deformities?

Interspinous implant in lumbar spinal stenosis: a prospective cohort

Lumbar spinal stenosis is a narrowing of spinal canal or neural foramina producing root ischaemia and neurogenic claudication[1–3]. Both the neural canal and foramen are narrowed with the spine in extension and opened in flexion. Patients are usually sixty years or over and present with unilateral or bilateral leg pain with or without back pain. The pain is worse on walking and if the patient is upright and relieved by sitting or bending forward[1–3]. With increasingly ageing population this is a common problem and difficult to deal with as many of the elderly patients have associated co-morbidities making them unsuitable for conventional decompressive surgery[4, 5]. Although lumbar spinal stenosis is one of the most frequent indications for spinal surgery in patients over 65 years of age[7], deciding the most appropriate procedure is a challenge to the clinicians. X-STOP interspinous implant is a titanium device. It was developed to prevent extension and also increase the dimension of spinal canal and neural foramina[5]. We are reporting the clinical outcome and patient satisfaction following indirect decompression with X-STOP.

Clinical skills in spinal assessment and management

The clinical skills in spinal assessment and management course was produced by the Raven Department of Education at the Royal College of Surgeons. Its aim is to teach trainees to assess and initially manage patients presenting with spinal conditions in the emergency department, outpatient, and ward settings. Courses are held twice a year, usually at the college but sometimes at other venues. This course is specifically aimed at orthopaedic and neurosurgical trainees at specialty trainee 2 level and above, but is also suitable for anyone who is likely to have a day to day commitment to the care of patients who have had a spinal injury or who need elective or emergency spinal surgery. Indications for spinal surgery are expanding, as illustrated by the recent guidance from the National Institute for Health and Clinical Excellence on management of metastatic spinal cord compression.1 The ageing of the population means that increasing numbers of people need decompression for stenosis, often combined with correction of degenerative scoliosis. It is essential that …