The Effect of Implant Density on Adolescent Idiopathic Scoliosis Fusion: Results of the Minimize Implants Maximize Outcomes Randomized Clinical Trial.

BACKGROUND: Severe adolescent idiopathic scoliosis (AIS) can be treated with instrumented fusion, but the number of anchors needed for optimal correction is controversial. METHODS: We conducted a multicenter, randomized study that included patients undergoing spinal fusion for single thoracic curves between 45° and 65°, the most common form of operatively treated AIS. Of the 211 patients randomized, 108 were assigned to a high-density screw pattern and 103, to a low-density screw pattern. Surgeons were instructed to use ≥1.8 implants per spinal level fused for patients in the high-implant-density group or ≤1.4 implants per spinal level fused for patients in the low-implant-density group. The primary outcome measure was the percent correction of the coronal curve at the 2-year follow-up. The power analysis for this trial required 174 patients to show equivalence, defined as a 95% confidence interval (CI) within a ±10% correction margin with a probability of 90%. RESULTS: In the intention-to-treat analysis, the mean percent correction of the coronal curve was equivalent between the high-density and low-density groups at the 2-year follow-up (67.6% versus 65.7%; difference, -1.9% [95% CI: -6.1%, 2.2%]). In the per-protocol cohorts, the mean percent correction of the coronal curve was also equivalent between the 2 groups at the 2-year follow-up (65.0% versus 66.1%; difference, 1.1% [95% CI: -3.0%, 5.2%]). A total of 6 patients in the low-density group and 5 patients in the high-density group required reoperation (p = 1.0). CONCLUSIONS: In the setting of spinal fusion for primary thoracic AIS curves between 45° and 65°, the percent coronal curve correction obtained with use of a low-implant-density construct and that obtained with use of a high-implant-density construct were equivalent. LEVEL OF EVIDENCE: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

BrAIST-Calc: Prediction of Individualized Benefit From Bracing for Adolescent Idiopathic Scoliosis.

STUDY DESIGN: Prospective multicenter study data were used for model derivation and externally validated using retrospective cohort data. OBJECTIVE: Derive and validate a prognostic model of benefit from bracing for adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: The Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) demonstrated the superiority of bracing over observation to prevent curve progression to the surgical threshold; 42% of untreated subjects had a good outcome, and 28% progressed to the surgical threshold despite bracing, likely due to poor adherence. To avoid over-treatment and to promote patient goal setting and adherence, bracing decisions (who and how much) should be based on physician and patient discussions informed by individual-level data from high-quality predictive models. MATERIALS AND METHODS: Logistic regression was used to predict curve progression to <45° at skeletal maturity (good prognosis) in 269 BrAIST subjects who were observed or braced. Predictors included age, sex, body mass index, Risser stage, Cobb angle, curve pattern, and treatment characteristics (hours of brace wear and in-brace correction). Internal and external validity were evaluated using jackknifed samples of the BrAIST data set and an independent cohort (n=299) through estimates of discrimination and calibration. RESULTS: The final model included age, sex, body mass index, Risser stage, Cobb angle, and hours of brace wear per day. The model demonstrated strong discrimination ( c -statistics 0.83-0.87) and calibration in all data sets. Classifying patients as low risk (high probability of a good prognosis) at the probability cut point of 70% resulted in a specificity of 92% and a positive predictive value of 89%. CONCLUSION: This externally validated model can be used by clinicians and families to make informed, individualized decisions about when and how much to brace to avoid progression to surgery. If widely adopted, this model could decrease overbracing of AIS, improve adherence, and, most importantly, decrease the likelihood of spinal fusion in this population.

Leading an Organization in the 21st Century: The Importance of Environmental Sustainability, Social Responsibility, and Good Governance.

The concept of environmental sustainability, social responsibility, and good governance (ESG) is now well established in the corporate world and in for-profit organizations. However, it is not a concept that has reached medical and surgical association boardrooms in a meaningful way. It is important to define the concept of physician and corporate author expertise and objectives of ESG, provide a rationale for using ESG within orthopaedic organizations, and identify specific areas (primarily the "S" and the "G") where the American Academy of Orthopaedic Surgeons and other groups can align with this strategy.

Developmental Dysplasia of the Hip From Birth to Adolescence: Clear Indications and New Controversies.

It is important to be knowledgeable about the latest information on the diagnosis and the evidence-based management of developmental hip dysplasia and dislocation from birth through adolescence. The focus should be on the effect of the problem; normal growth and development of the hip joint; and the pathoanatomy, natural history, and long-term outcomes of developmental dysplasia of the hip, hip subluxation, and dysplasia. Many controversies exist in the management of this complex spectrum of disorders.

How and When to Transition to the Next Phase: Reflections.

With Americans living longer, many physicians and surgeons have extended their medical and surgical practice life beyond the traditional 65-year-old retirement age. As retirement is inevitable, planning for that eventuality, which in early practice years appears unnecessary, is in fact an exercise which will pay dividends at the time of retirement. Two senior orthopaedic surgeons provide insight on the 2 main issues concerning retirement: how to prepare for retirement while in active practice, and factors to consider as to the timing of that major life event.

Health Literacy in Clubfoot: A Quantitative Assessment of the Readability, Understandability and Actionability of Online Patient Education Material.

BACKGROUND: Parents often access online resources to educate themselves when a child is diagnosed with clubfoot and/ or prior to treatment initiation. In order to be fully understood by the average adult American, online health information must be written at an elementary school reading level. It was hypothesized that current available online resources regarding clubfoot would score poorly on objective measures of readability (syntax reading grade-level), understandability (ability to process key messages), and actionability (providing actions the reader may take). Additionally, it was hypothesized that the outcomes measured would not correlate with the order of listed search results. METHODS: Patient education materials were identified utilizing two independent online searches (Google.com) of the term "Clubfoot". From the top 50 search results, websites were included if directed at educating patients and their families regarding clubfoot. News articles, non-text material (video), research and journal articles, industry websites, and articles not related to clubfoot were excluded. The readability of included resources was quantified using the Flesch Reading Ease Score (FRES), Flesch-Kincaid Grade Level (FKGL), Simple Measure of Gobbledygook (SMOG) Grade, Coleman-Liau Index (CLI), Gunning-Fog Index( GFI) and Automated Reading Index (ARI). The Patient Education Materials Assessment Tool (PEMAT) was used to assess actionability and understandability using a 0-100% scale for both measures of interest. RESULTS: Of the 55 unique websites, 37 websites (65.2%) met inclusion criteria. The mean FKGL was 9.2 (+/- 2.1) with only three websites (7.32%) having a reading level ≤6. Mean understandability and actionability scores were 67.2±12.6 and 25.4±25.2, respectively. Thirteen (35%) websites met the understandability threshold of ≥70% but no websites met the actionability criteria. No readability statistics were statistically associated with Google™ search rank (p=0.07). There was no association between readability (p=0.94) nor actionability (p=0.18) scores and Google™ rank. However, understandability scores did correlate with Google™ rank (p=0.02). CONCLUSION: Overall, online clubfoot educational materials scored poorly with respect to readability, understandability, and actionability. There is an association with Google™ search rank for understandability of clubfoot materials. However, readability and actionability are not significantly associated with search rank. In the era of shared decision-making, efforts should be made by medical professionals to improve the readability, understandability, and actionability of online resources in order to optimize parent understanding and facilitate effective outcomes.Level of Evidence.

Deformity correction using proximal hooks and distal screws (PHDSs) improves radiological metrics in adolescent idiopathic scoliosis.

PURPOSE: Surgical correction for AIS has evolved from all hooks to hybrids or all screw constructs. Limited literature exists reporting outcomes using PHDS for posterior spinal fusion (PSF). This is the largest series in evaluating results of PHDS technique. METHODS: A retrospective review of consecutive AIS patients undergoing PSF by a single surgeon between 2006 and 2015 was performed. All eligible patients met a minimum 2-year follow-up. Patient demographics and radiographical parameters (radiographic shoulder height (RSH), T1 tilt, clavicle angle) at baseline, 6-week and 2-year post-operation were recorded. The primary outcome was difference in RSH from baseline measurements evaluated using repeated measures one-way analysis of variance with Bonferroni correction. RESULTS: A total of 219 patients (mean age at surgery: 13.68 years; 82% female) were included. The mean follow-up was 41.2 months (range 24-108 months). The RSH was significantly improved from - 14.7 ± 10.38 mm to 8.0 ± 6.9 mm (P < 0.0001). Clavicle angle was improved from 2.13° to 1.31° (P < 0.0001). T1 tilt was improved from 5.6° to 2.2° (P < 0.0001). At last follow-up, 95.8% of patients were shoulder balanced. There was a significant improvement of Cobb angle with an average correction of the upper thoracic curve of 42% and main thoracic curve of 67%. CONCLUSION: The PHDS demonstrates the potential for additional shoulder balance improvement. Extension of fusion to structural proximal thoracic spine is the key to success for shoulder balance. It remains to be seen whether these improvements will translate into improved clinical outcomes in the longer term.

Early-Onset Scoliosis Treated With Magnetically Controlled Growing Rods.

The recently developed magnetically controlled growing rod (MCGR) system has gained popularity because it limits additional surgical lengthening procedures and promises reduction of the complication rate previously reported for the traditional growing rods. A retrospective single-center study was performed. Demographic and complications data were recorded. A statistical analysis was conducted to quantify the effect of MCGR placement and of subsequent lengthening on the Cobb angle, T1-T12 kyphosis, and the distances from T1-T12 and T1-S1. Twenty-four patients met the inclusion criteria. Six had idiopathic scoliosis and 18 patients had nonidiopathic scoliosis (neuromuscular and syndromic scoliosis). Nine patients underwent primary MCGR placement, and 15 had the traditional growing rods removed and replaced with MCGRs. The mean age at surgery and at last follow-up was 6.3 years and 8.8 years, respectively. The mean follow-up was 29.2 months. The MCGR placement significantly reduced the Cobb angle and kyphosis by an average of 21.33° and 10.79°, respectively. The T1-T12 and the T1-S1 distances increased an average of 1.19 and 1.89 cm/year, respectively, during the follow-up period. The average percentage of achieved-to-intended distraction was 65% on the concave side and 68% on the convex side at last follow-up. There were 9 postoperative complications in 8 (33%) patients, 6 of whom had nonidiopathic scoliosis. The MCGR system is reliable and effective in the treatment of patients affected by early-onset scoliosis. [Orthopedics. 2020;43(6):e601-e608.].

Closed Vs. Open Reduction/Salter Innominate Osteotomy for Developmental Hip Dislocation After Age 18 Months: Comparative Survival at 45-Year Follow-up.

BACKGROUND: Despite widespread use of single-stage open reduction and pelvic osteotomy for treatment of developmental dysplasia of the hip (DDH) after walking age, this aggressive strategy remains controversial. We directly compared dislocated hips treated with closed reduction (CR) to those treated with open reduction and Salter innominate osteotomy (OR/IO) to estimate the relative hazard of total hip arthroplasty (THA) and the THA-free survival time. METHODS: In a series of patients 18 to 60 months of age, 45 patients (58 hips) underwent CR and 58 patients (78 hips) were treated with OR/IO and followed to a minimum 40 years post-reduction. Observations in the survival analysis were censored if no THA had occurred by 48 years. Multivariate Cox regression analysis was used to estimate the hazard of THA given treatment, age, and bilaterality. Complications and additional procedures were noted. RESULTS: At 48 years of follow-up, 29 (50%) of the hips survived after CR compared with 54 (69%) after OR/IO. At 45 years, the survival probability after OR/IO was 0.63 (95% confidence interval [CI] = 0.50 to 0.78) compared with 0.55 (95% CI = 0.43 to 0.72) after CR. The hazard ratio (HR) of THA was modeled as a function of treatment, age at reduction, and bilaterality. The effect of age and treatment on the outcome of hips in patients with unilateral involvement was minimal. However, age did significantly alter the relationship between treatment and outcome in bilateral cases. In the bilateral group, the predicted HR of THA was lower after CR in hips that were reduced at the age of 18 months (HR = 0.16, 95% CI = 0.04 to 0.64) but higher in those that were reduced at 36 months (HR = 4.23, 95% CI = 2.00 to 8.95). Additional procedures were indicated for 17% and 22% of hips after CR and OR/IO, respectively. CONCLUSIONS: Osteoarthritis and THA was more likely after CR than OR/IO, but the data do not indicate a difference in unadjusted hip-survival time. In patients with bilateral disease, an older age at reduction was associated with an increased hazard of THA after CR than after OR/IO. Both treatments provided substantial benefit relative to the natural history of DDH, but THA is the expected outcome in middle adulthood. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Obtaining Imaging Cost and Quality Information in Femoroacetabular Impingement: The Patient Experience.

Background: Recent changes in healthcare have placed increased emphasis on price transparency, quality measures, and improving the patient experience. However, limited information is available for patient cost of obtaining a hip MRI and factors associated with cost variability. For a patient with femoroacetabular impingement (FAI), this study sought to report (1) the availability of pricing and quality information for a hip magnetic resonance imaging (MRI) in the state of Iowa, (2) the time investment required to obtain pricing and quality information, and (3) factors that influence hip MRI cost, quality and the time investment required for patients to obtain cost and quality information. Methods: Within the state of Iowa, 126 unique hospital institutions and 30 active, private orthopaedic practices were identified. All 156 providers were contacted via telephone using a standardized script of a hypothetical 25-year-old adult male patient with FAI requesting a quote for a hip MRI. Cost of the MRI and its components, availability of payment discounts, and MRI magnet tesla (T) were requested. A final bundled cost (FBC) was calculated for each MRI provider with all available services and discounts applied. The total amount of time needed to obtain a quote from each location was recorded. Results: One hundred and thirty-six of the 156 institutions contacted provided hip MRI services (87%). Median call duration was 9.1 minutes (Range 2.3-25.6). Median FBC was $2,114.00 (Range $484.75-4,463.00) across all providers. Hospital median FBC was $2,261.70 (Range $909.62-4,463.00) versus $1,225.13 (Range $484.75-2,218.40) for independent imaging centers (P<0.0001). No difference in median cost was observed between nine available 3.0 T machines and eighty-nine 1.5 T machines (P=0.2655). Conclusions: MRI cost varies widely across the state of Iowa and within individual metropolitan areas. Hip MRIs cost less at independent imaging centers compared to hospital locations. The amount of time required to obtain quality and cost data for a hip MRI presents a substantial time burden for patients with FAI. Surgeons, healthcare systems, and policy makers should be cognizant of the large price differences for a hip MRI and the time burden placed on patients with FAI to obtain this information.Level of Evidence: IV.

More severe thoracic idiopathic scoliosis is associated with a greater three-dimensional loss of thoracic kyphosis.

STUDY DESIGN: Retrospective. OBJECTIVES: Utilize three-dimensional (3D) measurements to assess the relationship between thoracic scoliosis severity and thoracic kyphosis in a large, multicenter cohort, and determine impact of 3D measurements on adolescent idiopathic scoliosis (AIS) curve classification. Research has demonstrated differences in two-dimensional (2D) and 3D assessment of the sagittal plane deformity in AIS. A prior smaller, single-institution study demonstrated an association between scoliosis severity and loss of 3D thoracic kyphosis. METHODS: Data included retrospective compilation of prospectively enrolled bracing candidates and prospectively enrolled surgical candidates with thoracic AIS. Analysis included two groups based on thoracic curve magnitude: moderate (20-45°) and severe (> 45°). Imaging was performed using 2D radiographs. 3D thoracic kyphosis was calculated using a 2D to 3D conversion formula. Kyphosis was categorized according to the Lenke classification sagittal plane modifier. RESULTS: Analysis included 3032 patients. 2D kyphosis was significantly less in the moderate group (21 ± 12 vs 23 ± 14, p = 0.028). However, estimated 3D kyphosis was significantly greater in the moderate group (13 ± 10 vs 5 ± 12, p < 0.001). In the moderate group, the rate of normokyphosis was 78% with 2D measures and 61% with 3D measures of T5-T12 kyphosis. In the severe group, this rate changed from 72 to 32% with use of 2D and 3D measures, respectively. In the moderate group, 16% of patients were classified as hypokyphotic using 2D measures while this rate increased 38% with 3D measures (p < 0.001). In the severe group, this rate changed from 18 to 68% using 2D and 3D measures, respectively (p < 0.001). CONCLUSIONS: Increased coronal curve severity was associated with decreased thoracic kyphosis. Hypokyphosis was more pronounced in 3D. 2D radiographs increasingly underestimate kyphosis with increasing coronal severity. Assessment of sagittal alignment from 2D radiographs can be improved with a 2D-3D conversion formula. Findings indicate potential for classification system improvement with use of 3D sagittal plane measurements. LEVEL OF EVIDENCE: IV.

Adolescent Idiopathic Scoliosis Bracing Success Is Influenced by Time in Brace: Comparative Effectiveness Analysis of BrAIST and ISICO Cohorts.

STUDY DESIGN: Comparative effectiveness study OBJECTIVE.: To evaluate factors leading to higher percentage of brace failures in a cohort of North American patients with adolescent idiopathic scoliosis relative to their peers in Italy. SUMMARY OF BACKGROUND DATA: Studies of bracing in United States have shown worse outcomes than studies from European centers, possibly due to sample characteristics or treatment approaches. METHODS: Sample: Braced patients, aged 10 to 15, Risser <3, Cobb 20°- to 40°, observed to Cobb ≥40° and/or ≥Risser 4 selected from prospective databases. Comparators: Bracing per Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) (TLSO) and Italian Scientific Spine Institute (ISICO) protocol (SPoRT braces with or without SEAS exercises). Baseline characteristics (sex, age, BMI, Risser, Cobb, curve type) and average hours of brace wear/day. Differences in programs (e.g., SEAS, type of brace, weaning protocol) were captured by a variable named "SITE." OUTCOME: Treatment failure (Cobb ≥40 before Risser 4). STATISTICS: Comparison of baseline characteristics, analyses of risk factors, treatment components, and outcomes within and between cohorts using logistic regression. RESULTS: A total of 157 BrAIST and 81 ISICO subjects were included. Cohorts were similar at baseline but differed significantly in terms of average hours of brace wear: 18.31 in the ISICO versus 11.76 in the BrAIST cohort. Twelve percent of the ISICO and 39% of the BrAIST cohort had failed treatment. Age, Risser, Cobb, and a thoracic apex predicted failure in both groups. SITE was related to failure (odds ratio [OR] = 0.19), indicating lower odds of failure with ISICO versus BrAIST approach. With both SITE and wear time in the model, SITE loose significance. In the final model, the adjusted odds of failure were higher in boys (OR = 3.34), and those with lowest BMI (OR = 9.83); the odds increased with the Cobb angle (OR = 1.23), and decreased with age (OR = 0.41) and hours of wear (OR = 0.86). CONCLUSION: Treatment at the ISICO resulted in a lower failure rate, primarily explained by longer average hours of brace wear. LEVEL OF EVIDENCE: 3.

Establishing consensus on the best practice guidelines for the use of bracing in adolescent idiopathic scoliosis.

STUDY DESIGN: Survey. OBJECTIVES: Bracing is the mainstay of conservative treatment in Adolescent Idiopathic Scoliosis (AIS). The purpose of this study was to establish best practice guidelines (BPG) among a multidisciplinary group of international bracing experts including surgeons, physiatrists, physical therapists, and orthotists utilizing formal consensus building techniques. Currently, there is significant variability in the practice of brace treatment for AIS and, therefore, there is a strong need to develop BPG for bracing in AIS. METHODS: We utilized the Delphi process and the nominal group technique to establish consensus among a multidisciplinary group of bracing experts. Our previous work identified areas of variability in brace treatment that we targeted for consensus. Following a review of the literature, three iterative surveys were administered. Topics included bracing goals, indications for starting and discontinuing bracing, brace types, brace prescription, radiographs, physical activities, and physiotherapeutic scoliosis-specific exercises. A face-to-face meeting was then conducted that allowed participants to vote for or against inclusion of each item. Agreement of 80% throughout the surveys and face-to-face meeting was considered consensus. Items that did not reach consensus were discussed and revised and repeat voting for consensus was performed. RESULTS: Of the 38 experts invited to participate, we received responses from 32, 35, and 34 for each survey, respectively. 11 surgeons, 4 physiatrists, 8 physical therapists, 3 orthotists, and 1 research scientist participated in the final face-to-face meeting. Experts reached consensus on 67 items across 10 domains of bracing which were consolidated into the final best practice recommendations. CONCLUSIONS: We believe that adherence to these BPG will lead to fewer sub-optimal outcomes in patients with AIS by reducing the variability in AIS bracing practices, and provide a framework future research. LEVEL OF EVIDENCE: Level IV.

Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST): Development and Validation of a Prognostic Model in Untreated Adolescent Idiopathic Scoliosis Using the Simplified Skeletal Maturity System.

STUDY DESIGN: Prognostic study and validation using prospective clinical trial data. OBJECTIVE: To derive and validate a model predicting curve progression to ≥45° before skeletal maturity in untreated patients with adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: Studies have linked the natural history of AIS with characteristics such as sex, skeletal maturity, curve magnitude, and pattern. The Simplified Skeletal Maturity Scoring System may be of particular prognostic utility for the study of curve progression. The reliability of the system has been addressed; however, its value as a prognostic marker for the outcomes of AIS has not. The BrAIST trial followed a sample of untreated AIS patients from enrollment to skeletal maturity, providing a rare source of prospective data for prognostic modeling. METHODS: The development sample included 115 untreated BrAIST participants. Logistic regression was used to predict curve progression to ≥45° (or surgery) before skeletal maturity. Predictors included the Cobb angle, age, sex, curve type, triradiate cartilage, and skeletal maturity stage (SMS). Internal and external validity was evaluated using jackknifed samples of the BrAIST data set and an independent cohort (n = 152). Indices of discrimination and calibration were estimated. A risk classification was created and the accuracy evaluated via the positive (PPV) and negative predictive values (NPV). RESULTS: The final model included the SMS, Cobb angle, and curve type. The model demonstrated strong discrimination (c-statistics 0.89-0.91) and calibration in all data sets. The classification system resulted in PPVs of 0.71-0.72 and NPVs of 0.85-0.93. CONCLUSIONS: This study provides the first rigorously validated model predicting a short-term outcome of untreated AIS. The resultant estimates can serve two important functions: 1) setting benchmarks for comparative effectiveness studies and 2) most importantly, providing clinicians and families with individual risk estimates to guide treatment decisions. LEVEL OF EVIDENCE: Level 1, prognostic.

Determining the Prevalence and Costs of Unnecessary Referrals in Adolescent Idiopathic Scoliosis.

Background: Adolescent idiopathic scoliosis (AIS) has been associated with unnecessary referrals, but the provider and patient costs associated with these referrals remain unknown. The purpose of this study was to determine the prevalence and associated costs of unnecessary referrals for AIS in a university hospital-based orthopaedic clinic. These data are required to estimate the cost-efficacy of scoliosis screening programs. Methods: We accessed the electronic medical records of all patients referred during 2013-2014 with suspected AIS. Spine radiographs were reviewed to determine whether the referral was "unnecessary," defined as a Cobb angle <20 degrees. Patient and provider costs were estimated. Patient costs included transportation expenses and parental lost wages. Provider costs included orthopaedic evaluation, diagnostic imaging, and overhead. Transportation costs were based on actual driving distances and the Internal Revenue Service standard mileage rate. Parental lost wages and the cost of evaluation by an orthopaedic surgeon were calculated with time-driven activity-based costing. Diagnostic imaging costs were calculated with a traditional activity-based costing methodology. Results: Three hundred thirty-seven patients were included. The prevalence of unnecessary referrals was 39% (n=131). 17% of patients had a Cobb angle <10 degrees and 22% had a Cobb angle between 10-20 degrees. Males were more likely to be referred unnecessarily than females, 49% to 35% (p=0.02) as were non-Caucasians (54% vs. 37%, p=0.04). No difference was noted related to source of insurance (private or public, p=0.18). The average total cost of an unnecessary referral was $782.13 USD, including $231.07 in patient costs and $551.06 in provider costs. Conclusions: Nearly 40% of all referrals for AIS were deemed unnecessary. The average cost of an unnecessary referral is approximately $780, imposing significant costs on both patients and the healthcare system.Level of Evidence: III.