Obesity increases the odds of intervertebral disc herniation and spinal stenosis; an MRI study of 1634 low back pain patients.

PURPOSE: The objective of this study was to examine the relationships between BMI and intervertebral disc degeneration (DD), disc herniation (DH) and spinal stenosis (SS) using a large, prospectively recruited and heterogeneous patient population. METHODS: Patients were recruited through the European Genodisc Study. An experienced radiologist scored MRI images for DD, DH and SS. Multivariate linear and logistic regression analyses were used to model the relationship between these variables and BMI with adjustment for patient and MRI confounders. RESULTS: We analysed 1684 patients with a mean age of 51 years and BMI of 27.2 kg/m2.The mean DD score was 2.6 (out of 5) with greater DD severity with increasing age (R2 = 0.44). In the fully adjusted model, a 10-year increase in age and a 5 kg/m2 increase in BMI were associated, respectively, with a 0.31-unit [95% CI 0.29,0.34] and 0.04-unit [CI 0.01,0.07] increase in degeneration. Age (OR 1.23 [CI 1.06,1.43]) and BMI (OR 2.60 [CI 2.28,2.96]) were positively associated with SS. For DH, age was a negative predictor (OR 0.70 [CI 0.64,0.76]) but for BMI (OR 1.19 [CI 1.07,1.33]), the association was positive. BMI was the strongest predictor of all three features in the upper lumbar spine. CONCLUSIONS: While an increase in BMI was associated with only a slight increase in DD, it was a stronger predictor for DH and SS, particularly in the upper lumbar discs, suggesting weight loss could be a useful strategy for helping prevent disorders associated with these pathologies.

Factors predicting the transition from acute to persistent pain in people with 'sciatica': the FORECAST longitudinal prognostic factor cohort study protocol.

INTRODUCTION: Sciatica is a common condition and is associated with higher levels of pain, disability, poorer quality of life, and increased use of health resources compared with low back pain alone. Although many patients recover, a third develop persistent sciatica symptoms. It remains unclear, why some patients develop persistent sciatica as none of the traditionally considered clinical parameters (eg, symptom severity, routine MRI) are consistent prognostic factors.The FORECAST study (factors predicting the transition from acute to persistent pain in people with 'sciatica') will take a different approach by exploring mechanism-based subgroups in patients with sciatica and investigate whether a mechanism-based approach can identify factors that predict pain persistence in patients with sciatica. METHODS AND ANALYSIS: We will perform a prospective longitudinal cohort study including 180 people with acute/subacute sciatica. N=168 healthy participants will provide normative data. A detailed set of variables will be assessed within 3 months after sciatica onset. This will include self-reported sensory and psychosocial profiles, quantitative sensory testing, blood inflammatory markers and advanced neuroimaging. We will determine outcome with the Sciatica Bothersomeness Index and a Numerical Pain Rating Scale for leg pain severity at 3 and 12 months.We will use principal component analysis followed by clustering methods to identify subgroups. Univariate associations and machine learning methods optimised for high dimensional small data sets will be used to identify the most powerful predictors and model selection/accuracy.The results will provide crucial information about the pathophysiological drivers of sciatica symptoms and may identify prognostic factors of pain persistence. ETHICS AND DISSEMINATION: The FORECAST study has received ethical approval (South Central Oxford C, 18/SC/0263). The dissemination strategy will be guided by our patient and public engagement activities and will include peer-reviewed publications, conference presentations, social media and podcasts. TRIAL REGISTRATION NUMBER: ISRCTN18170726; Pre-results.

Automated measurement of size of spinal curve in population-based cohorts: Validation of a method based on total body dual energy X-ray absorptiometry scans.

BACKGROUND: Scoliosis is spinal curvature that may progress to require surgical stabilisation. Risk factors for progression are little understood due to lack of population-based research, since radiographs cannot be performed on entire populations due to high levels of radiation. To help address this, we have previously developed and validated a method for quantification of spinal curvature from total body dual energy X-ray absorptiometry (DXA) scans. The purpose of this study was to automate this quantification of spinal curve size from DXA scans using machine learning techniques. METHODS: To develop the automation of curve size, we utilised manually annotated scans from 7298 participants from the Avon Longitudinal Study of Parents and Children (ALSPAC) at age 9 and 5122 at age 15. To validate the automation we assessed (1) agreement between manual vs automation using the Bland-Altman limits of agreement, (2) reliability by calculating the coefficient of variation, and (3) clinical validity by running the automation on 4969 non-annotated scans at age 18 to assess the associations with physical activity, body composition, adipocyte function and backpain compared to previous literature. RESULTS: The mean difference between manual vs automated readings was less than one degree, and 90.4 % of manual vs automated readings fell within 10°. The coefficient of variation was 25.4 %. Clinical validation showed the expected relationships between curve size and physical activity, adipocyte function, height and weight. CONCLUSION: We have developed a reasonably accurate and valid automated method for quantifying spinal curvature from DXA scans for research purposes.

External validation of the deep learning system "SpineNet" for grading radiological features of degeneration on MRIs of the lumbar spine.

BACKGROUND: Magnetic resonance imaging (MRI) is used to detect degenerative changes of the lumbar spine. SpineNet (SN), a computer vision-based system, performs an automated analysis of degenerative features in MRI scans aiming to provide high accuracy, consistency and objectivity. This study evaluated SN's ratings compared with those of an expert radiologist. METHOD: MRIs of 882 patients (mean age, 72 ± 8.8 years) with degenerative spinal disorders from two previous trials carried out in our spine center between 2011 and 2019, were analyzed by an expert radiologist. Lumbar segments (L1/2-L5/S1) were graded for Pfirrmann Grades (PG), Spondylolisthesis (SL) and Central Canal Stenosis (CCS). SN's analysis for the equivalent parameters was generated. Agreement between methods was analyzed using kappa (κ), Spearman correlation (ρ) and Lin's concordance correlation (ρc) coefficients and class average accuracy (CAA). RESULTS: 4410 lumbar segments were analyzed. κ statistics showed moderate to substantial agreement in PG between the radiologist and SN depending on spinal level (range κ 0.63-0.77, all levels together 0.72; range CAA 45-68%, all levels 55%), slight to substantial agreement for SL (range κ 0.07-0.60, all levels 0.63; range CAA 47-57%, all levels 56%) and CCS (range κ 0.17-0.57, all levels 0.60; range CAA 35-41%, all levels 43%). SN tended to record more pathological features in PG than did the radiologist whereas the contrary was the case for CCS. SL showed an even distribution between methods. CONCLUSION: SN is a robust and reliable tool with the ability to grade degenerative features such as PG, SL or CCS in lumbar MRIs with moderate to substantial agreement compared to the current gold-standard, the radiologist. It is a valuable alternative for analyzing MRIs from large cohorts for diagnostic and research purposes.

Consensus on a standardised treatment pathway algorithm for lumbar spinal stenosis: an international Delphi study.

BACKGROUND: Lumbar spinal stenosis (LSS) is a common degenerative spinal condition in older adults associated with disability, diminished quality of life, and substantial healthcare costs. Individual symptoms and needs vary. With sparse and sometimes inconsistent evidence to guide clinical decision-making, variable clinical care may lead to unsatisfactory patient outcomes and inefficient use of healthcare resources. METHODS: A three-phase modified Delphi study comprising four consensus rounds was conducted on behalf of the International Taskforce for the Diagnosis and Management of LSS to develop a treatment algorithm based on multi-professional international expert consensus. Participants with expertise in the assessment and management of people with LSS were invited using an international distribution process used for two previous Delphi studies led by the Taskforce. Separate treatment pathways for patients with different symptom types and severity were developed and incorporated into a proposed treatment algorithm through consensus rounds 1 to 3. Agreement with the proposed algorithm was evaluated in the final consensus round. RESULTS: The final algorithm combines stratified and stepped approaches. When indicated, immediate investigation and surgery is advocated. Otherwise, a stepped approach is suggested when self-directed care is unsatisfactory. This starts with tailored rehabilitation, then more complex multidisciplinary care, investigations and surgery options if needed. Treatment options in each step depend on clinical phenotype and symptom severity. Treatment response guides pathway entrance and exit points. Of 397 study participants, 86% rated their agreement ≥ 4 for the proposed algorithm on a 0-6 scale, of which 22% completely agreed. Only 7% disagreed. Over 70% of participants felt that the algorithm would be useful for clinicians in public healthcare (both primary care and specialist settings) and in private healthcare settings, and that a simplified version would help patients in shared decision-making. CONCLUSIONS: International and multi-professional agreement was achieved for a proposed LSS treatment algorithm developed through expert consensus. The algorithm advocates different pathway options depending on clinical indications. It is not intended as a treatment protocol and will require evaluation against current care for clinical and cost-effectiveness. It may, however, serve as a clinical guide until evidence is sufficient to inform a fully stratified care model.

The Clinical Effectiveness of a Physiotherapy Delivered Physical and Psychological Group Intervention for Older Adults With Neurogenic Claudication: The BOOST Randomized Controlled Trial.

BACKGROUND: Neurogenic claudication (NC) is a debilitating spinal condition affecting older adults' mobility and quality of life. METHODS: A randomized controlled trial of 438 participants evaluated the effectiveness of a physical and psychological group intervention (BOOST program) compared to physiotherapy assessment and tailored advice (best practice advice [BPA]) for older adults with NC. Participants were identified from spinal clinics (community and secondary care) and general practice records and randomized 2:1 to the BOOST program or BPA. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data were also collected at 6 months. Other outcomes included ODI walking item, 6-minute walk test (6MWT), and falls. The primary analysis was intention-to-treat. RESULTS: The average age of participants was 74.9 years (standard deviation [SD] 6.0) and 57% (246/435) were female. There was no significant difference in ODI scores between treatment groups at 12 months (adjusted mean difference [MD]: -1.4 [95% confidence intervals (CI) -4.03, 1.17]), but, at 6 months, ODI scores favored the BOOST program (adjusted MD: -3.7 [95% CI -6.27, -1.06]). At 12 months, the BOOST program resulted in greater improvements in walking capacity (6MWT MD: 21.7m [95% CI 5.96, 37.38]) and ODI walking item (MD: -0.2 [95% CI -0.45, -0.01]) and reduced falls risk (odds ratio: 0.6 [95% CI 0.40, 0.98]) compared to BPA. No serious adverse events were related to either treatment. CONCLUSIONS: The BOOST program substantially improved mobility for older adults with NC. Future iterations of the program will consider ways to improve long-term pain-related disability. Clinical Trials Registration Number: ISRCTN12698674.

The Prevalence of Back and Leg Pain and the Cross-sectional Association With Adverse Health Outcomes in Community Dwelling Older Adults in England.

STUDY DESIGN: Cross-sectional analysis of the Oxford Pain, Activity and Lifestyle (OPAL) Cohort Study. OBJECTIVE: The aim of this study was to assess the prevalence of back pain (BP) and leg pain and determine their relationship with adverse health states among older adults in England. SUMMARY OF BACKGROUND DATA: Epidemiological data describing the prevalence of BP and leg pain in older adults in England is lacking. METHODS: A total of 5304 community-dwelling adults (aged 65-100 years) enrolled in the OPAL cohort study who provided data on BP and leg pain were included. Participants were classified into four groups based on reports of back and leg pain: no BP, BP only, BP and leg pain which was likely to be neurogenic claudication (NC), and BP and leg pain which was not NC. Adverse health states were frailty, falls, mobility decline, low walking confidence, poor sleep quality, and urinary incontinence. We collected demographic and socioeconomic information, health-related quality of life, and existing health conditions, and estimated the association between BP presentations and adverse health states using regression analysis. RESULTS: Thirty-four percent of participants (1786/5304) reported BP only, 11.2% (n = 594/5304) reported BP and NC and 8.3% (n = 441/5304) reported BP and non-NC leg pain. Participants with BP had worse quality of life compared to those without BP. All BP presentations were significantly associated with adverse health states. Those with NC were most affected. In particular, there was greater relative risk (RR) of low walking confidence (RR 3.11, 95% confidence interval [CI] 2.56-3.78), frailty (RR 1.88, 95% CI 1.67-2.11), and mobility decline (RR 1.74, 95% CI 1.54-1.97) compared to no BP. CONCLUSION: Back and leg pain is a common problem for older adults and associated with reduced quality of life and adverse health states. Findings suggest a need to develop more effective treatment for older adults with BP especially for those with neurogenic claudication. LEVEL OF EVIDENCE: 2.

Correction to: Identifying Scoliosis in Population­Based Cohorts: Automation of a Validated Method Based on Total Body Dual Energy X­ray Absorptiometry Scans.

In the original version of the article, the co-author would like to add to the acknowledgements section to highlight their funding stream (EPSRC). The revised acknowledgements is given below.

Could automated machine-learned MRI grading aid epidemiological studies of lumbar spinal stenosis? Validation within the Wakayama spine study.

BACKGROUND: MRI scanning has revolutionized the clinical diagnosis of lumbar spinal stenosis (LSS). However, there is currently no consensus as to how best to classify MRI findings which has hampered the development of robust longitudinal epidemiological studies of the condition. We developed and tested an automated system for grading lumbar spine MRI scans for central LSS for use in epidemiological research. METHODS: Using MRI scans from the large population-based cohort study (the Wakayama Spine Study), all graded by a spinal surgeon, we trained an automated system to grade central LSS in four gradings of the bone and soft tissue margins: none, mild, moderate, severe. Subsequently, we tested the automated grading against the independent readings of our observer in a test set to investigate reliability and agreement. RESULTS: Complete axial views were available for 4855 lumbar intervertebral levels from 971 participants. The machine used 4365 axial views to learn (training set) and graded the remaining 490 axial views (testing set). The agreement rate for gradings was 65.7% (322/490) and the reliability (Lin's correlation coefficient) was 0.73. In 2.2% of scans (11/490) there was a difference in classification of 2 and in only 0.2% (1/490) was there a difference of 3. When classified into 2 groups as 'severe' vs 'no/mild/moderate'. The agreement rate was 94.1% (461/490) with a kappa of 0.75. CONCLUSIONS: This study showed that an automated system can "learn" to grade central LSS with excellent performance against the reference standard. Thus SpineNet offers potential to grade LSS in large-scale epidemiological studies involving a high volume of MRI spine data with a high level of consistency and objectivity.

Current perspectives on the role of biomechanical loading and genetics in development of disc degeneration and low back pain; a narrative review.

Degenerative changes in the disc have long been of interest; they are thought to be strongly associated with low back pain and caused by inappropriate loading or through injury. However, independent of the magnitude of occupational spinal loading, twin studies find that the heritability of lumbar disc degeneration is 34-74%. This finding has led to intensive searches for susceptibility genes; some genes associated with disc degeneration have been identified, though all with small effects on the degenerative process. The complex nature of degenerative changes suggests that many different genes are involved, and that interactions with environmental factors are influential in progression of degeneration. Low back pain itself also appears heritable (30-46%). The most important clinical question though, is not how discs degenerate but is disc degeneration related to low back pain. Imaging studies find many people with degenerate discs or even with discs showing pathological features such as herniations, are asymptomatic. However results are obscured by the lack of consistent definitions of the phenotypes of disc degeneration and of low back pain. Epidemiological studies could help disentangle these complex relationships, but they will only be successful once consistent classifications and phenotypes of both disc degeneration and low back pain are developed.

Identifying Scoliosis in Population-Based Cohorts: Automation of a Validated Method Based on Total Body Dual Energy X-ray Absorptiometry Scans.

Scoliosis is a 3D-torsional rotation of the spine, but risk factors for initiation and progression are little understood. Research is hampered by lack of population-based research since radiographs cannot be performed on entire populations due to the relatively high levels of ionising radiation. Hence we have developed and validated a manual method for identifying scoliosis from total body dual energy X-ray absorptiometry (DXA) scans for research purposes. However, to allow full utilisation of population-based research cohorts, this needs to be automated. The purpose of this study was therefore to automate the identification of spinal curvature from total body DXA scans using machine learning techniques. To validate the automation, we assessed: (1) sensitivity, specificity and area under the receiver operator curve value (AUC) by comparison with 12,000 manually annotated images; (2) reliability by rerunning the automation on a subset of DXA scans repeated 2-6 weeks apart and calculating the kappa statistic; (3) validity by applying the automation to 5000 non-annotated images to assess associations with epidemiological variables. The final automated model had a sensitivity of 86.5%, specificity of 96.9% and an AUC of 0.80 (95%CI 0.74-0.87). There was almost perfect agreement of identification of those with scoliosis (kappa 0.90). Those with scoliosis identified by the automated model showed similar associations with gender, ethnicity, socioeconomic status, BMI and lean mass to previous literature. In conclusion, we have developed an accurate and valid automated method for identifying and quantifying spinal curvature from total body DXA scans.

Multicentre, double-blind, randomised, sham-controlled trial of 10 khz high-frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol.

INTRODUCTION: Chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. Evidence demonstrates that high-frequency 10 kHz spinal cord stimulation (SCS) reduces pain and improves health-related quality of life in patients with failed back surgery syndrome (FBSS), but evidence of this effect is limited in individuals with CNLBP who have not had surgery. The aim of this multicentre randomised trial is to assess the clinical and cost-effectiveness of 10 kHz SCS for this population. METHODS: This is a multicentre, double-blind, randomised, sham-controlled trial with a parallel economic evaluation. A total of 96 patients with CNLBP who have not had spinal surgery will be implanted with an epidural lead and a sham lead outside the epidural space without a screening trial. Patients will be randomised 1:1 to 10 kHz SCS plus usual care (intervention group) or to sham 10 kHz SCS plus usual care (control group) after receiving the full implant. The SCS devices will be programmed identically using a cathodal cascade. Participants will use their handheld programmer to alter the intensity of the stimulation as per routine practice. The primary outcome will be a 7-day daily pain diary. Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5 L, and health and social care costs. Outcomes will be assessed at baseline (pre-randomisation) and at 1 month, 3 months and 6 months after device activation. The primary analyses will compare primary and secondary outcomes between groups at 6 months, while adjusting for baseline outcome scores. Incremental cost per quality-adjusted life year (QALY) will be calculated at 6 months and over the lifetime of the patient. DISCUSSION: The outcomes of this trial will inform clinical practice and healthcare policy on the role of high-frequency 10 kHz SCS for use in patients with CNLBP who have not had surgery. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03470766. Registered on 20 March 2018. DISCLAIMER: The views expressed here are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The NIHR had no role in the study design, writing of the manuscript or the decision to submit for publication. ROLES AND RESPONSIBILITIES: AK, SP, DP, SW, RST, AC, SE, LM, RD and JF all contributed to the trial design and to securing trial funding. AK, JR, SP, DP, and SE are involved in the recruitment, the intervention and the follow-up. SW will perform data collection and analysis. RST will be responsible for the statistical analysis, and RD will be responsible for the health economic analysis. All authors read and approved the final manuscript.

Controversies in regenerative medicine: Should intervertebral disc degeneration be treated with mesenchymal stem cells?

Low back pain (LBP) can significantly reduce the quality of life of patients, and has a considerable economic and social impact worldwide. It is commonly associated with disc degeneration, even though many people with degenerate discs are asymptomatic. Degenerate disc disease (DDD), is thus a common term for intervertebral disc (IVD) degeneration associated with LBP. Degeneration is thought to lead to LBP because of nerve ingrowth into the degenerate disc, inflammation, or because degradation of extracellular matrix (ECM) alters spinal biomechanics inappropriately. Thus, while the objectives of some interventions for LBP are to control pain intensity, other interventions aim to deal with the consequences of disc degeneration through stabilizing the disc surgically, by inserting artificial discs or by repairing the disc biologically and preventing progressive IVD degeneration. Despite tremendous research efforts, treatment of LBP through the use of regenerative interventions aiming to repair the IVD is still controversial. The use of mesenchymal stem cells for IVD regeneration in a patient-based case will be discussed by an ensemble of clinicians and researchers.

Association between physical activity and scoliosis: a prospective cohort study.

BACKGROUND: Little is understood about the causes of adolescent onset idiopathic scoliosis (AIS). No prospective studies assessing the association between physical activity and idiopathic adolescent scoliosis have been carried out. We aimed to carry out the first prospective population-based study of this association. METHODS: The Avon Longitudinal Study of Parents and Children (ALSPAC) collected self-reported measures of physical ability/activity at ages 18 months and 10 years. Objective measures of physical activity were collected by accelerometry at age 11 years. scoliosis was identified using the dxa scoliosis Method at age 15 years. Participants with scoliosis at age 10 years were excluded. RESULTS: Of 4640 participants at age 15 years who had DXA scans, 267 (5.8%) had scoliosis. At age 18 months, those infants who were able to stand up without being supported were 66% less likely to have developed scoliosis by age 15 (P = 0.030) compared with infants who could not. Those children whose mothers reported they did most vigorous physical activity at age 10 years were 53% less likely to develop scoliosis (P = 0.027). Those children who did more objectively measured moderate/vigorous physical activity at age 11 were 30% less likely to have developed scoliosis (P < 0.001). Results were not affected by adjustment for age, gender, lean mass, fat mass or back pain. CONCLUSIONS: We report reduced physical ability and activity as early as age 18 months in those who go on to develop scoliosis by age 15 years. Further research is justified to examine the mechanisms underlying this association.

Leptin and the intervertebral disc: a biochemical link exists between obesity, intervertebral disc degeneration and low back pain-an in vitro study in a bovine model.

PURPOSE: The aim of this study was to identify the effects of leptin upon the intervertebral disc (IVD) and to determine whether these responses are potentiated within an environment of existing degeneration. Obesity is a significant risk factor for low back pain (LBP) and IVD degeneration. Adipokines, such as leptin, are novel cytokines produced primarily by adipose tissue and have been implicated in degradative and inflammatory processes. Obese individuals are known to have higher concentrations of serum leptin, and IVD cells express leptin receptors. We hypothesise that adipokines, such as leptin, mediate a biochemical link between obesity, IVD degeneration and LBP. METHODS: The bovine intervertebral disc was used as a model system to investigate the biochemical effects of obesity, mediated by leptin, upon the intervertebral disc. Freshly isolated cells, embedded in 3D alginate beads, were subsequently cultured under varying concentrations of leptin, alone or together with the pro-inflammatory cytokines TNF-α, IL-1ß or IL-6. Responses in relation to production of nitric oxide, lactate, glycosaminoglycans and expression of anabolic and catabolic genes were analysed. RESULTS: Leptin influenced the cellular metabolism leading particularly to greater production of proteases and NO. Addition of leptin to an inflammatory environment demonstrated a marked deleterious synergistic effect with greater production of NO, MMPs and potentiation of pro-inflammatory cytokine production. CONCLUSIONS: Leptin can initiate processes involved in IVD degeneration. This effect is potentiated in an environment of existing degeneration and inflammation. Hence, a biochemical mechanism may underlie the link between obesity, intervertebral disc degeneration and low back pain. These slides can be retrieved under Electronic Supplementary Material.

Better Outcomes for Older people with Spinal Trouble (BOOST) Trial: a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication, a protocol.

INTRODUCTION: Neurogenic claudication due to spinal stenosis is common in older adults. The effectiveness of conservative interventions is not known. The aim of the study is to estimate the clinical and cost-effectiveness of a physiotherapist-delivered, combined physical and psychological intervention. METHODS AND ANALYSIS: This is a pragmatic, multicentred, randomised controlled trial. Participants are randomised to a combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme) or best practice advice (control). Community-dwelling adults, 65 years and over, with neurogenic claudication are identified from community and secondary care services. Recruitment is supplemented using a primary care-based cohort. Participants are registered prospectively and randomised in a 2:1 ratio (intervention:control) using a web-based service to ensure allocation concealment. The target sample size is a minimum of 402. The BOOST programme consists of an individual assessment and twelve 90 min classes, including education and discussion underpinned by cognitive behavioural techniques, exercises and walking circuit. During and after the classes, participants undertake home exercises and there are two support telephone calls to promote adherence with the exercises. Best practice advice is delivered in one to three individual sessions with a physiotherapist. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the 6 Minute Walk Test, Short Physical Performance Battery, Fear Avoidance Beliefs Questionnaire and Gait Self-Efficacy Scale. Outcomes are measured at 6 and 12 months by researchers who are masked to treatment allocation. The primary statistical analysis will be by 'intention to treat'. There is a parallel health economic evaluation and qualitative study. ETHICS AND DISSEMINATION: Ethical approval was given on 3 March 2016 (National Research Ethics Committee number: 16/LO/0349). This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials checklist. The results will be reported at conferences and in peer-reviewed publications using the Consolidated Standards of Reporting Trials guidelines. A plain English summary will be published on the BOOST website. TRIAL REGISTRATION NUMBER: ISRCTN12698674; Pre-results.

Systematic review of the complications associated with magnetically controlled growing rods for the treatment of early onset scoliosis.

PURPOSE: To analyse the complication profile of magnetically controlled growing rods (MCGRs) in early onset scoliosis (EOS). METHODS: This is a systematic review using PUBMED, Medline, Embase, Google Scholar and the Cochrane Library (keywords: MAGEC, Magnetically controlled growing rods and EOS) of all studies written in English with a minimum of five patients and a 1-year follow-up. We evaluated coronal correction, growth progression (T1-S1, T1-T12) and complications. RESULTS: Fifteen studies (336 patients) were included (42.5% male, mean age 7.9 years, average follow-up 29.7 months). Coronal improvement was achieved in all studies (pre-operative 64.8°, latest follow-up 34.9° p = 0.000), as was growth progression (p = 0.001). Mean complication rate was 44.5%, excluding the 50.8% medical complication rate. The unplanned revision rate was 33%. The most common complications were anchor pull-out (11.8%), implant failure (11.7%) and rod breakage (10.6%). There was no significant difference between primary (39.8%) and conversion (33.3%) procedures (p = 0.462). There was a non-statistically significant increased complication rate with single rods (40 vs. 27% p = 0.588). CONCLUSIONS: MCGRs improve coronal deformity and maintain spinal growth, but carry a 44.5% complication and 33% unplanned revision rate. Conversion procedures do not increase this risk. Single rods should be avoided. These slides can be retrieved under Electronic Supplementary material.