RESUMO
BACKGROUND: Radiotherapy delivery regimens can vary between a single fraction (SF) and multiple fractions (MF) given daily for up to several weeks depending on the location of the cancer or metastases. With limited evidence comparing fractionation regimens for oligometastases, there is support to explore toxicity levels to nearby organs at risk as a primary outcome while using SF and MF stereotactic ablative radiotherapy (SABR) as well as explore differences in patient-reported quality of life and experience. METHODS: This study will randomize 598 patients in a 1:1 ratio between the standard arm (MF SABR) and the experimental arm (SF SABR). This trial is designed as two randomized controlled trials within one patient population for resource efficiency. The primary objective of the first randomization is to determine if SF SABR is non-inferior to MF SABR, with respect to healthcare provider (HCP)-reported grade 3-5 adverse events (AEs) that are related to SABR. Primary endpoint is toxicity while secondary endpoints include lesional control rate (LCR), and progression-free survival (PFS). The second randomization (BC Cancer sites only) will allocate participants to either complete quality of life (QoL) questionnaires only; or QoL questionnaires and a symptom-specific survey with symptom-guided HCP intervention. The primary objective of the second randomization is to determine if radiation-related symptom questionnaire-guided HCP intervention results in improved reported QoL as measured by the EuroQoL-5-dimensions-5levels (EQ-5D-5L) instrument. The primary endpoint is patient-reported QoL and secondary endpoints include: persistence/resolution of symptom reporting, QoL, intervention cost effectiveness, resource utilization, and overall survival. DISCUSSION: This study will compare SF and MF SABR in the treatment of oligometastases and oligoprogression to determine if there is non-inferior toxicity for SF SABR in selected participants with 1-5 oligometastatic lesions. This study will also compare patient-reported QoL between participants who receive radiation-related symptom-guided HCP intervention and those who complete questionnaires alone. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT05784428. Date of Registration: 23 March 2023.
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Neoplasias , Radiocirurgia , Humanos , Neoplasias/mortalidade , Neoplasias/patologia , Neoplasias/radioterapia , Intervalo Livre de Progressão , Qualidade de Vida , Radiocirurgia/efeitos adversos , Radiocirurgia/métodos , Estudos de Equivalência como AsuntoRESUMO
AIM: To develop and validate a risk calculator based on preoperative factors to predict the probability of surgical site infection (SSI) in patients with cerebral palsy (CP) undergoing spinal surgery. METHOD: This was a multicenter retrospective cohort study of pediatric patients with CP who underwent spinal fusion. In the development stage, preoperative known factors were collected, and a risk calculator was developed by comparing multiple models and choosing the model with the highest discrimination and calibration abilities. This model was then tested with a separate population in the validation stage. RESULTS: Among the 255 patients in the development stage, risk of SSI was 11%. A final prediction model included non-ambulatory status (odds ratio [OR] 4.0), diaper dependence (OR 2.5), age younger than 12 years (OR 2.5), major coronal curve magnitude greater than 90° (OR 1.3), behavioral disorder/delay (OR 1.3), and revision surgery (OR 1.3) as risk factors. This model had a predictive ability of 73.4% for SSI, along with excellent calibration ability (p = 0.878). Among the 390 patients in the validation stage, risk of SSI was 8.2%. The discrimination of the model in the validation phase was 0.743 and calibration was p = 0.435, indicating 74.3% predictive ability and no difference between predicted and observed values. INTERPRETATION: This study provides a risk calculator to identify the risk of SSI after spine surgery for patients with CP. This will allow us to enhance decision-making and patient care while providing valid hospital comparisons, public reporting mechanisms, and reimbursement determinations.
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Paralisia Cerebral , Fusão Vertebral , Paralisia Cerebral/complicações , Paralisia Cerebral/cirurgia , Criança , Humanos , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fusão Vertebral/efeitos adversos , Infecção da Ferida Cirúrgica/diagnóstico , Infecção da Ferida Cirúrgica/epidemiologia , Infecção da Ferida Cirúrgica/etiologiaRESUMO
The purpose of this study was to assess the performance of structure-guided deformable image registration (SG-DIR) relative to rigid registration and DIR using TG-132 recommendations. This assessment was performed for image registration of treatment planning computed tomography (CT) and magnetic resonance imaging (MRI) scans with Primovist® contrast agent acquired post stereotactic body radiation therapy (SBRT). SBRT treatment planning CT scans and posttreatment Primovist® MRI scans were obtained for 14 patients. The liver was delineated on both sets of images and matching anatomical landmarks were chosen by a radiation oncologist. Rigid registration, DIR, and two types of SG-DIR (using liver contours only; and using liver structures along with anatomical landmarks) were performed for each set of scans. TG-132 recommended metrics were estimated which included Dice Similarity Coefficient (DSC), Mean Distance to Agreement (MDA), Target Registration Error (TRE), and Jacobian determinant. Statistical analysis was performed using Wilcoxon Signed Rank test. The median (range) DSC for rigid registration was 0.88 (0.77-0.89), 0.89 (0.81-0.93) for DIR, and 0.90 (0.86-0.94) for both types of SG-DIR tested in this study. The median MDA was 4.8 mm (3.7-6.8 mm) for rigid registration, 3.4 mm (2.4-8.7 mm) for DIR, 3.2 mm (2.0-5.2 mm) for SG-DIR where liver structures were used to guide the registration, and 2.8 mm (2.1-4.2 mm) for the SG-DIR where liver structures and anatomical landmarks were used to guide the registration. The median TRE for rigid registration was 7.2 mm (0.5-23 mm), 6.8 mm (0.7-30.7 mm) for DIR, 6.1 mm (1.1-20.5 mm) for the SG-DIR guided by only the liver structures, and 4.1 mm (0.8-19.7 mm) for SG-DIR guided by liver contours and anatomical landmarks. The SG-DIR shows higher liver conformality as per TG-132 metrics and lowest TRE compared to rigid registration and DIR in Velocity AI software for the purpose of registering treatment planning CT and post-SBRT MRI for the liver region. It was found that TRE decreases when liver contours and corresponding anatomical landmarks guide SG-DIR.
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Gadolínio DTPA , Processamento de Imagem Assistida por Computador/métodos , Neoplasias Hepáticas/patologia , Imageamento por Ressonância Magnética/métodos , Radiocirurgia/métodos , Planejamento da Radioterapia Assistida por Computador/métodos , Tomografia Computadorizada por Raios X/métodos , Algoritmos , Humanos , Neoplasias Hepáticas/diagnóstico por imagem , Neoplasias Hepáticas/cirurgia , Órgãos em Risco/efeitos da radiação , Intensificação de Imagem Radiográfica/métodos , Dosagem Radioterapêutica , Radioterapia de Intensidade Modulada/métodosRESUMO
BACKGROUND: Although pediatric medial epicondylar fractures and apophysitis are well studied, patterns of subapophyseal avulsion and ligamentous injuries of the medial elbow in this population merit investigation to inform optimal treatment strategies. PURPOSE: To describe the occurrence and demographic correlates of ulnar collateral ligament (UCL) avulsion and soft tissue injuries of the pediatric and adolescent elbow. STUDY DESIGN: Cross-sectional study; Level of evidence, 3. METHODS: An institutional review board-approved review was conducted to identify consecutive patients with medial elbow injuries treated in a tertiary pediatric sports medicine practice between 2016 and 2021. Radiographs were obtained during injury evaluation, and patients with nondisplaced medial epicondylar apophysitis and complete epicondylar fracture were excluded, resulting in 150 patients with soft tissue injuries occurring distal to the medial epicondyle apophysis (subapophyseal) for study. Radiographs were evaluated for bony avulsion of the UCL from either the medial epicondyle proximally or the ulnar sublime tubercle distally. Injuries without radiographic evidence of bony avulsion, but with clinical examination findings consistent with ligamentous injury, were classified as radiographically negative UCL injuries, and magnetic resonance imaging (MRI) was performed to further evaluate these injuries if moderate to severe medial swelling of the elbow or significant concern for medial structural injury was present on examination. These MRI scans were evaluated to classify the UCL injury and assess for periosteal or cartilaginous avulsions. RESULTS: A total of 150 patients (mean age, 12.5 ± 3.4 years; 70 female), 55% (150/274) of the entire medial elbow injury population, had a subapophyseal injury. Of these patients, 62 had a bony avulsion detected on radiograph, and 88 had a radiographically negative injury. In addition to the 62 radiographic avulsions, the 61 MRI scans obtained on those radiographically negative injuries revealed 33 complete UCL disruptions, resulting in 63.3% (95/150) of patients sustaining a complete ligamentous disruption. With the MRI scans, 37 (61%) cases of cartilaginous or periosteal avulsion of the UCL were diagnosed. Overall, 66% of all 150 subapophyseal injuries had a bony, cartilaginous, or periosteal UCL avulsion. Patients with cartilaginous (mean age, 10.3 years) and bony (mean age, 10.6 years) avulsions were younger than those with central ligament injury (mean age, 14.2 years) or periosteal (mean age, 14.2 years) avulsions (P = .005). There was a significant association between the mechanism of injury and the location of UCL tear identified on MRI scans: traumatic falls were associated with distal tears, and throwing injuries were associated with proximal tears (P < .001). CONCLUSION: UCL central ligament and avulsion lesions may be frequently diagnosed after injury to the pediatric medial elbow, the majority of which are complete injuries, and may require MRI for diagnosis. The mechanism of injury may predict the location of ligamentous injury, and osteocartilaginous avulsions are more likely to present at younger ages than injuries to the soft tissue of the UCL or periosteum. The prevalence of these injuries merits further investigation into best protocols of nonoperative treatment or surgical repair techniques and outcomes.
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Ligamento Colateral Ulnar , Lesões no Cotovelo , Imageamento por Ressonância Magnética , Lesões dos Tecidos Moles , Humanos , Adolescente , Criança , Feminino , Ligamento Colateral Ulnar/lesões , Ligamento Colateral Ulnar/diagnóstico por imagem , Masculino , Estudos Transversais , Lesões dos Tecidos Moles/diagnóstico por imagem , Articulação do Cotovelo/diagnóstico por imagem , RadiografiaRESUMO
PURPOSE: Best Practice Guidelines (BPGs) were published one decade ago to decrease surgical site infection (SSI) in pediatric spinal deformity. Successful implementation has not been established. This study evaluated surgeon compliance with items on the BPG. We hypothesized that BPG authors and surgeons with more experience, higher caseload, and awareness of the BPG would have higher compliance. METHODS: We queried North American and European surgeons, authors and non-authors, and members of various spine study groups on adherence to BPGs using an anonymous survey. Mean compliance scores (MCSs) were developed by correlating Likert responses with MCSs ("None of the time" = no compliance = MCS 0, "Sometimes" = weak to moderate = MCS 1, "Most of the time" = high = MCS 2, "All the time" = perfect = MCS 3). RESULTS: Of the 142 respondents, 73.7% reported high or perfect compliance. Average compliance scores for all guidelines was 2.2 ± 0.4. There were significantly different compliance scores between North American and European surgeons (2.3 vs 1.8, p < 0.001), authors and non-authors (2.5 vs. 2.2, p = 0.023), and surgeons with and without knowledge of the BPGs (2.3 vs. 1.8, p < 0.001). There was a weak correlation between BPG awareness and compliance (r = 0.34, p < 0.001) and no correlation between years in practice (r = 0.0, p = 0.37) or yearly caseload (r = 0.2, p = 0.78) with compliance. CONCLUSIONS: Compliance among our cohort of surgeons surveyed was high. North American surgeons, authors of the BPGs and those aware of the guidelines had increased compliance. Participation in a spine study group, years in practice, and yearly caseload were not associated with compliance. LEVEL OF EVIDENCE: Level V-expert opinion.
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Cirurgiões , Infecção da Ferida Cirúrgica , Humanos , Criança , Infecção da Ferida Cirúrgica/prevenção & controle , Coluna Vertebral/cirurgia , Inquéritos e QuestionáriosRESUMO
PURPOSE: In 2018, Best Practice Guidelines (BPGs) were published for preventing wrong-level surgery in pediatric spinal deformity, but successful implementation has not been established. The purpose of this study was to evaluate BPG compliance 5 years after publication. We hypothesized higher compliance among BPG authors and among surgeons with more experience, higher caseload, and awareness of the BPGs. METHODS: We queried North American and European surgeons, authors and nonauthors, and members of pediatric spinal study groups on adherence to BPGs using an anonymous survey consisting of 18 Likert scale questions. Respondents provided years in practice, yearly caseload, and guideline awareness. Mean compliance scores (MCS) were developed by correlating Likert responses with MCS scores ("None of the time" = no compliance = MCS 0, "Sometimes" = weak to moderate = MCS 1, "Most of the time" = high = MCS 2, and "All the time" = perfect = MCS 3). RESULTS: Of the 134 respondents, 81.5% reported high or perfect compliance. Average MCS for all guidelines was 2.4 ± 0.4. North American and European surgeons showed no compliance differences (2.4 vs. 2.3, p = 0.07). Authors and nonauthors showed significantly different compliance scores (2.8 vs 2.4, p < 0.001), as did surgeons with and without knowledge of the BPGs (2.5 vs 2.2, p < 0.001). BPG awareness and compliance showed a moderate positive correlation (r = 0.48, p < 0.001), with non-significant associations between compliance and both years in practice (r = 0.41, p = 0.64) and yearly caseload (r = 0.02, p = 0.87). CONCLUSION: Surgeons reported high or perfect compliance 81.5% of the time with BPGs for preventing wrong-level surgery. Authorship and BPG awareness showed increased compliance. Location, study group membership, years in practice, and yearly caseload did not affect compliance. LEVEL OF EVIDENCE: Level V-expert opinion.
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Fidelidade a Diretrizes , Guias de Prática Clínica como Assunto , Humanos , Fidelidade a Diretrizes/estatística & dados numéricos , Criança , Inquéritos e Questionários , Coluna Vertebral/cirurgia , Procedimentos Ortopédicos/normasRESUMO
PURPOSE: In children with early onset scoliosis (EOS) who have tethered spinal cord (TSC), spinal cord detethering is commonly performed prior to spinal deformity correction (SDC). The purpose of this study was to investigate whether age or curve magnitude at the time of detethering is associated with curve progression at a follow-up of at least 2 years. It was hypothesized that patients who undergo detethering at a younger age, or those with a smaller curve magnitude, would experience a reduced rate of curve progression when compared with those who are older or with larger curves. METHODS: Patients with EOS who underwent detethering at least 2 years prior to SDC were identified in a multicenter international registry. Radiographs were assessed just prior to the detethering procedure (pre-detether) and at the most recent visit prior to SDC (most recent post-detether). The rate of curve progression > 10° was examined. Owing to unequal follow-up in individual patients, Cox regression was used to investigate associations between primary variables (age and magnitude of major coronal curve) and rate of curve progression. RESULTS: 37 patients met inclusion criteria and 18 (mean age: 3.7 ± 2.9 years, 66.7% female, mean follow-up: 3.4 ± 1.3 years) had radiographic data available for analysis. Pre-detether and most recent post-detether major coronal curves were 44.8° ± 18.5° and 47.6° ± 23.9°, respectively. 5 (27.8%) patients had curve progression > 10° at a follow-up of 3.2 ± 1.2 years. Patients with progression > 10° were older at the time of detethering when compared with those without (5.6 ± 2.8 vs. 3 ± 2.7 years, p = 0.084). Regression analysis demonstrated that as age at detethering increased by 1 year, the rate of curve progression > 10° increased by 28.6% [95% confidence interval (CI) 0.899; 1.839, p = 0.169]. There was no evidence of an association between pre-detethering curve magnitude and rate of curve progression > 10° [HR: 1.027, 95% CI 0.977; 1.079, p = 0.297]. CONCLUSION: In a small multicenter cohort of EOS patients with TSC, younger age, but not curve size, at the time of detethering was associated with a lower rate of scoliosis progression. Although these results indicate a potential role for early spinal cord detethering in the EOS population, they require further prospective investigation with a larger number of patients. LEVEL OF EVIDENCE: Level II.
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Defeitos do Tubo Neural , Escoliose , Humanos , Criança , Feminino , Lactente , Pré-Escolar , Masculino , Escoliose/diagnóstico por imagem , Escoliose/cirurgia , Escoliose/complicações , Resultado do Tratamento , Estudos Retrospectivos , Defeitos do Tubo Neural/complicações , Medula EspinalRESUMO
PURPOSE: This study sought to investigate associations between upper instrumented vertebra (UIV) location and the risk of proximal junctional kyphosis (PJK) at 2 years following posterior spinal fusion (PSF) for Scheuermann's kyphosis (SK). METHODS: In this retrospective cohort study, SK patients who underwent PSF and reached 2 years postop were identified in a multicenter international registry, excluding those with anterior release, prior spine surgery, neuromuscular comorbidity, post-traumatic kyphosis, or kyphosis apex below T11-T12. Location of UIV as well as the number of levels between UIV and preoperative kyphosis apex was determined. Additionally, the degree of kyphosis correction was evaluated. PJK was defined as a proximal junctional angle ≥ 10° that is ≥ 10° greater than the preoperative measurement. RESULTS: 90 patients (16.5 ± 1.9 yo, 65.6% male) were included. Preoperative and 2-year postoperative major kyphosis was 74.6 ± 11.6° and 45.9 ± 10.5°, respectively. Twenty-two (24.4%) patients developed PJK at 2 years. Patients with UIV below T2 had a 2.09 times increased risk of PJK when compared to those with UIV at or above T2, adjusting for distance between UIV and preoperative kyphosis apex [95% Confidence Interval (CI) 0.94; 4.63, p = 0.070]. Patients with UIV ≤ 4.5 vertebrae from the apex had a 1.57 times increased risk of PJK, adjusting for UIV relative to T2 [95% CI 0.64; 3.87, p = 0.326]. CONCLUSION: SK patients with UIV below T2 had an increased risk of developing PJK at 2 years following PSF. This association supports consideration of UIV location during preoperative planning. LEVEL OF EVIDENCE: Prognostic Level II.
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Doença de Scheuermann , Fusão Vertebral , Humanos , Masculino , Feminino , Doença de Scheuermann/etiologia , Estudos Retrospectivos , Coluna Vertebral/cirurgia , Fusão Vertebral/efeitos adversos , Período Pós-OperatórioRESUMO
Development of a novel auto-delineation methodology for observed hypointensity from focal liver reaction in hepatobiliary-specific contrast (Primovist) enhanced MRI acquired post Stereotactic Body Radiation Therapy (SBRT). Additionally, the methodology for the quantification of the threshold dose associated with the observed focal liver reaction was also established. An auto-delineation algorithm was created based on the correlation between intensity and radiation dose information. The error associated with the auto-delineation was quantified using virtual FLRs, as well as clinical patient scans. Patients underwent liver SBRT with a total dose prescription of 50 Gy in 5 fractions. An inherent correlation was established between the contrast-to-noise ratio (CNR) on MRI scans and expected performance of the algorithm using centre-of-mass (COM). Threshold dose associated with focal liver reaction was quantified for all ten patients and verified with associated most conformal isodose line. Based on the CNR vs COM error relationship, the expected median (range) auto-delineation COM error for ten patients was 0.5 (0 to 3.2) mm. The median threshold dose for ten clinical cases was 21.3 Gy based on the auto-delineation framework. This threshold dose was compared to the most conformal isodose line with the hypointensity; there was no significant difference observed (p = 0.6). We developed a framework for post-SBRT Primovist observed focal liver reaction localization. Furthermore, this study established an automated approach for the determination of the threshold dose associated with the hypointense region.
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Neoplasias Hepáticas , Radiocirurgia , Gadolínio DTPA , Humanos , Fígado , Neoplasias Hepáticas/radioterapia , Imageamento por Ressonância Magnética , Radiocirurgia/efeitos adversos , Planejamento da Radioterapia Assistida por ComputadorRESUMO
BACKGROUND: The 24-question Early-Onset Scoliosis Questionnaire (EOSQ-24) is a proxy measure assessing health-related quality of life (HRQoL) among patients with early-onset scoliosis (EOS). There exists an increasing need to assess HRQoL through a child's own perspective, particularly for older children and adolescents with EOS. The purpose of this study was to develop and validate a self-reported questionnaire, the Early-Onset Scoliosis Self-Report Questionnaire (EOSQ-SELF), to assess HRQoL in older children and adolescents with EOS. METHODS: A literature review, an expert focus group, and patient interviews were used to generate a preliminary survey of appropriate domains and question items. This survey was provided to English-speaking patients with EOS who were 8 to 18 years of age and capable of answering survey questions. Content validity was assessed for clarity and relevance of questions. Confirmatory factors analysis was performed to reduce the number of items and determine domains that fit items. Reliability was evaluated by measuring the internal consistency of items and test-retest reliability. Construct validity was evaluated by convergent, discriminant, and known-group validity. RESULTS: The literature review, expert focus group, and patient interviews identified 59 questions in 14 domains. Psychometric analysis reduced these to 30 questions across 12 domains: General Health, Pain/Discomfort, Pulmonary Function, Transfer, Physical Function/Daily Living, Participation, Fatigue/Energy Level, Sleep, Appearance, Relationships, Emotion, and Satisfaction. The final questionnaire was found to have good content and construct validity and adequate reliability. CONCLUSIONS: The EOSQ-SELF is a valid and reliable instrument for measuring self-reported HRQoL among older children and adolescents with EOS (ages 8 to 18 years). This will serve as an important research outcome measure and enhance clinical care by providing a better understanding of HRQoL for these patients. LEVEL OF EVIDENCE: Diagnostic Level II . See Instructions for Authors for a complete description of levels of evidence.
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Qualidade de Vida , Escoliose , Adolescente , Criança , Fadiga , Humanos , Psicometria , Reprodutibilidade dos Testes , Escoliose/diagnóstico , Escoliose/psicologia , Autorrelato , Inquéritos e QuestionáriosRESUMO
PURPOSE: The purpose of this study was to describe contraindications to the magnetically controlled growing rod (MCGR) in patients with early onset scoliosis (EOS) by establishing consensus amongst expert surgeons who treat these patients frequently. METHODS: Nine pediatric spine surgeons from an international EOS study group participated in semi-structured interviews via email to identify factors that influence decision making in the use of MCGR. A 39-question survey was then developed to specify these factors as contraindications for MCGR-these included patient age and size, etiology, medical comorbidities, coronal and sagittal curve profiles, and skin and soft tissue characteristics. Pediatric spine surgeons from the EOS international study group were invited to complete the survey. A second 29-item survey was created to determine details and clarify results from the first survey. Responses were analyzed for consensus (> 70%), near consensus (60-69%), and no consensus/variability (< 60%) for MCGR contraindication. RESULTS: 56 surgeons of 173 invited (32%) completed the first survey, and 64 (37%) completed the second survey. Responders had a mean of over 15 years in practice (range 1-45) with over 6 years of experience with using MCGR (range 2-12). 71.4% of respondents agreed that patient size characteristics should be considered as contraindications, including BMI (81.3%) and spinal height (84.4%), although a specific BMI range or a specific minimum spinal height were not agreed upon. Among surgeons who agreed that skin and soft tissue problems were contraindications (78.6%), insufficient soft tissue (98%) and skin (89%) to cover MCGR were specified. Among surgeons who reported curve stiffness as a contraindication (85.9%), there was agreement that this curve stiffness should be defined by clinical evaluation (78.2%) and by traction films (72.3%). Among surgeons who reported sagittal curve characteristics as contraindications, hyperkyphosis (95.3%) and sagittal curve apex above T3 (70%) were specified. Surgeons who indicated the need for repetitive MRI as a contraindication (79.7%) agreed that image quality (72.9%) and not patient safety (13.6%) was the concern. In the entire cohort, consensus was not achieved on the following factors: patient age (57.4%), medical comorbidities (46.4%), etiology (53.6%), and coronal curve characteristics (58.9%). CONCLUSION: Surgeon consensus suggests that MCGR should be avoided in patients who have insufficient spinal height to accommodate the MCGR, have potential skin and soft tissue inadequacy, have too stiff a spinal curve, have too much kyphosis, and require repetitive MRI, particularly of the spine. Future data-driven studies using this framework are warranted to generate more specific criteria (e.g. specific degrees of kyphosis) to facilitate clinical decision making for EOS patients. LEVEL OF EVIDENCE: Level V-expert opinion.