Incidence of Nerve Palsies During Pavlik Harness Treatment for Developmental Dysplasia of the Hip: A Retrospective Cohort Study.

BACKGROUND: The Pavlik harness has been used for approximately a century to treat developmental dysplasia of the hip (DDH). Femoral nerve palsy is a documented complication of Pavlik harness use, with an incidence ranging from 2.5% to 11.2%. Rare reports of brachial plexus palsy have also been documented. The primary purpose of the current study was to evaluate the incidence of various nerve palsies in patients undergoing Pavlik harness treatment for DDH. Secondary aims were to identify patient demographic or hip characteristics associated with nerve palsy. METHODS: We performed a retrospective review of patients diagnosed with DDH and treated with a Pavlik harness from February 1, 2016, to April 1, 2023, at a single tertiary care orthopaedic hospital. Hip laterality, use of a subsequent rigid abduction orthosis, birth order, breech positioning, weight, and family history were collected. The median (and interquartile range [IQR]) or mean (and standard deviation [SD]) were reported for all continuous variables. Independent 2-sample t tests and Mann-Whitney U tests were conducted to identify associations between the variables collected at the initiation of Pavlik harness treatment and the occurrence of nerve palsy. RESULTS: Three hundred and fifty-one patients (547 hips) were included. Twenty-two cases of femoral nerve palsy (4% of all treated hips), 1 case of inferior gluteal nerve palsy (0.18%), and 2 cases of brachial plexus palsy (0.37%) were diagnosed. Patients with nerve palsy had more severe DDH as measured by the Graf classification (p < 0.001) and more severe DDH as measured on physical examination via the Barlow and Ortolani maneuvers (p = 0.003). CONCLUSIONS: Nerve palsies were associated with more severe DDH at the initiation of Pavlik harness use. Upper and lower-extremity neurological status should be scrutinized at initiation and throughout treatment to assess for nerve palsies. The potential for femoral, gluteal, and brachial plexus palsies should be included in the discussion of risks at the beginning of treatment. Families may be reassured that nerve palsies associated with Pavlik harness can be expected to resolve with a short break from treatment. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Hemiepiphysiodesis for Genu Valgum in Patients With Multiple Hereditary Exostoses.

BACKGROUND: Genu valgum is a well-known feature of multiple hereditary exostoses (MHE). Though prior reports have demonstrated successful treatment with hemiepiphysiodesis, details regarding the correction rate and comparison to an idiopathic population are lacking. This study aimed to detail our institution's experience with guided growth of the knee in patients with MHE and compare this to an idiopathic population. METHODS: All pediatric patients (age 18 and younger) with MHE who underwent lower extremity hemiepiphysiodesis at a tertiary care medical center between January 2016 and December 2022 were retrospectively reviewed. Preoperative and postoperative mechanical lateral distal femoral angle (mLDFA) and medial proximal tibial angle (MPTA, the primary outcomes) were measured in addition to mechanical axis deviation (MAD) and hip-knee-ankle angle (HKA). Patients were 1:2 matched based on age, sex, and physes instrumented to a cohort with idiopathic genu valgum. RESULTS: A total of 21 extremities in 16 patients with MHE underwent hemiepiphysiodesis of the distal femur, proximal tibia, and/or distal tibia. The mean age at surgery was 11.7±2.2 years. Mean MAD corrected from zone 1.9±0.7 to -0.3±1.5, while mLDFA corrected from 83.4±2.9 to 91.7±5.2 degrees and MPTA corrected from 95.3±3.6 to 90.5±4.0 degrees in distal femurs and proximal tibias undergoing guided growth, respectively. Three extremities (14.3%) experienced overcorrection ≥5 degrees managed with observation. There were no differences in correction rates per month for mLDFA (0.54±0.34 vs. 0.51±0.29 degrees, P =0.738) or MPTA (0.31±0.26 vs. 0.50±0.59 degrees, P =0.453) between MHE and idiopathic groups. For 11 extremities in the MHE group with open physes at hardware removal, they experienced a mean recurrence of HKA of 4.0±3.4 degrees at 19-month follow-up. CONCLUSION: Hemiepiphysiodesis corrects lower extremity malalignment in patients with MHE at a similar rate compared with an idiopathic coronal plane deformity population. Rebound deformity of 4 degrees at 19 months after hardware removal in patients with remaining open growth plates should make surgeons conscious of the remaining growth potential when planning deformity correction. LEVEL OF EVIDENCE: Level III.

Prone vs Supine Positioning for Femoral Derotation Osteotomy: Kinematic and Physical Examination Outcomes Suggest Both Can Achieve Desired Results.

Background: Femoral derotation osteotomy (FDO) for correction of internal rotation gait resulting from cerebral palsy (CP) can be performed with the patient in the prone or supine position. It is not known whether patient positioning during FDO affects the change in hip rotation. Purpose/Questions: We sought to compare the change in hip rotation following FDO performed on patients with CP in the prone or supine position through kinematic analysis. Methods: We conducted a consecutive retrospective cohort study of children with CP, ages 3 to 18 years and with Gross Motor Function Classification System (GMFCS) levels I to III, who underwent prone or supine FDO and pre- and postoperative motion analysis. The prone group included 37 patients (68 limbs) between 1990 and 1995. The supine group included 26 patients (47 limbs) between 2005 and 2015. The groups were matched for gender, age, and GMFCS level. The primary outcome was hip rotation in degrees during stance phase. Secondary outcomes included temporal-spatial parameters, hip abduction, hip and knee extension, and hip and knee passive range of motion (ROM). Results: The prone group had more bilateral patients (100%) than the supine group (81%). The supine group underwent more concomitant procedures. There was no difference between the prone and supine groups in postoperative stance hip rotation; both groups had significantly improved stance hip rotation, step width, and hip rotation passive ROM, pre- to postoperatively. Prone patients had improved postoperative hip extension, pelvic tilt, velocity, and cadence. Conclusions: There was no significant different in stance hip rotation between supine and prone FDO groups. Advocates of prone positioning for FDO suggest it allows more accurate assessment of rotation. Supine positioning may be more convenient when additional procedures are required. Based on our findings, either approach can achieve the desired result.

Pediatric orthopedic mythbusters: the truth about flexible flatfeet, tibial and femoral torsion, W-sitting, and idiopathic toe-walking.

PURPOSE OF REVIEW: Myths, widely held but false or unproven beliefs, exist in pediatric orthopedics, with the most common examples related to flexible flatfeet, in-toeing/out-toeing, W-sitting, and toe-walking. Concerns regarding these findings and suggested treatments, unfounded in science, may be passed along verbally or published through various media, without citation. The current review investigates these myths and provides up to date recommendations on diagnosis and treatment (or lack of necessary treatment) for these common pediatric orthopedic findings. RECENT FINDINGS: Orthotics used in childhood do not alter foot development for flexible flatfeet. W-sitting is not associated with developmental dysplasia of the hip, and there is no scientific evidence to support that it leads to contractures, hip dislocations, or functional deficits. SUMMARY: Misinformation about normal variants of growth in childhood and suggested treatments are rampant and can be found published through various media without citation, as supportive scientific studies do not exist or existing studies refute the claims. Flexible flatfeet, in-toeing/out-toeing, W-sitting, and toe-walking typically improve throughout childhood without intervention. Physical therapy, orthotics and bracing have not been proven effective. Treatment is required in rare scenarios and should be directed by the orthopedic surgeon.

Bariatric Surgery Prior to Total Hip Arthroplasty Is Cost-Effective in Morbidly Obese Patients.

BACKGROUND: The cost-effectiveness of bariatric surgery to achieve weight loss prior to total hip arthroplasty (THA), and decrease the complications and costs associated with THA in the morbidly obese, is unknown. This study evaluated the cost-effectiveness of bariatric surgery prior to THA for morbidly obese patients with end-stage hip osteoarthritis (OA). METHODS: A state-transition Markov model was constructed to compare the cost-utility of 2 treatment protocols for patients with morbid obesity and end-stage hip OA: (1) immediate THA and (2) bariatric surgery 2 years prior to THA (combined protocol). The analysis was performed from both a payer and a societal perspective using direct and indirect costs over a 40-year time horizon. Utilities, associated costs, and probabilities for health state transitions were derived from the literature. One-way, 2-way and probabilistic sensitivity analyses were performed to validate the robustness of the base case results, using the standard willingness-to-pay threshold of $100,000/quality-adjusted life years. RESULTS: From the societal perspective, the combined protocol was more effective (13.16 vs 12.26) with less cost ($91,717 vs $92,684) and thus was the dominant strategy over immediate THA. These results were stable across broad ranges for independent model variables. Monte Carlo simulation with 100,000 samples demonstrated that bariatric surgery prior to THA was the preferred cost-effective strategy over 95% of the time from both a societal and payer perspective. CONCLUSION: In the morbidly obese patient with end-stage hip OA, bariatric surgery prior to THA is a cost-effective strategy for improving quality of life and decreasing societal and payer costs. LEVEL OF EVIDENCE: II.

Health State Utilities in Children and Adolescents With Osteochondritis Dissecans of the Knee.

BACKGROUND: The impact of osteochondritis dissecans (OCD) lesions of the knee on a child's health-related quality of life has not previously been quantified. Preference-based health utility assessment allows patients to assign quality-of-life valuations (utilities) to different health states and conditions. PURPOSE: To determine (1) patient-reported utility scores for health states associated with pediatric OCD lesions of the knee and (2) whether these scores are associated with patient demographics or disease severity. STUDY DESIGN: Cross-sectional study; Level of evidence, 3. METHODS: Children, adolescents, and young adults being treated for OCD of the knee were interviewed to assess utilities for each of the 6 health states commonly encountered in the treatment of OCD: (1) symptomatic lesion, (2) nonoperative rehabilitation, (3) postoperative rehabilitation, (4) intermediate treatment success, (5) early degenerative knee changes, and (6) successful treatment (asymptomatic). Patients were asked to assign health utilities to each state using a standardized feeling thermometer (scale, 0-100), which were converted to a health state utility (scale, 0-1 [1 = perfect health]). Utilities were reported with descriptive statistics, and comparative analyses were performed to test whether assignments were associated with patient age, sex, or whether the OCD lesion required surgical intervention. RESULTS: A total of 100 participants treated or undergoing treatment for OCD were prospectively enrolled; 74% were male (n = 74). The median age at the time of survey was 15 years (interquartile range, 13-16.5 years). Utility scores were as follows: symptomatic OCD lesion, 0.15; nonoperative rehabilitation, 0.30; postoperative rehabilitation, 0.30; early degenerative changes, 0.58; intermediate treatment success, 0.65; and successful treatment, 1.0. Utility scores were not associated with age, sex, or whether the participant underwent surgical treatment for the OCD lesion. CONCLUSION: The current study quantified patient-reported utilities for 6 OCD lesion health states, which may be used for future health-related quality of life, decision analysis, and quality/safety/value studies. These utility scores were stable and not affected by patient age, sex, or treatment strategy.

Pediatric Septic Arthritis and Osteomyelitis in the USA: A National KID Database Analysis.

BACKGROUND: Prior reports suggest that osteoarticular infections may be increasing over time. QUESTIONS/PURPOSES: We sought to determine if incidence rates, median in-hospital costs, and length of stay (LOS) of osteomyelitis, septic arthritis (SA), and combined infections have changed over time for pediatric patients, and how they compare to previously reported rates. METHODS: The Kids' Inpatient Database (KID), a US national sample of pediatric hospital discharge records from 1997, 2000, 2003, 2006, 2009, and 2012, was used to determine yearly estimated counts of infections in children 20 years of age or younger. US census data was used to calculate yearly incidence rates. Trend tests using linear contrast analysis were used to compare estimated median LOS and inflation-adjusted median costs over time for each type of infection. RESULTS: From 1997 through 2012, the incidence rate of osteomyelitis increased from 7.9 to 10.5 per 100,000, SA was unchanged from 5.3 to 5.2 per 100, and combined infections increased from 0.8 to 1.3 per 100,000. Median LOS from 1997 to 2012 showed no significant change for osteomyelitis (5.0 to 4.9 days), SA (4.4 to 4.1 days), or combined infections (6.5 to 6.8 days). Median in-hospital costs from 1997 to 2012 increased for osteomyelitis ($7735 to $11,823), SA ($5041 to $10,574), and combined infections ($12,691 to $16,260). CONCLUSION: In pediatric patients, the estimated incidence rate of SA appeared stable, while rates of osteomyelitis and combined infections increased. These estimated rates fall within previously reported ranges. Despite stable LOS, costs have increased over time.

Capsulotomy in Unstable Slipped Capital Femoral Epiphysis and the Odds of AVN: A Meta-analysis of Retrospective Studies.

BACKGROUND: Unstable slipped capital femoral epiphysis (SCFE) may lead to avascular necrosis (AVN) in up to 60% of patients. The aim of this study was to assess the best clinical evidence to determine the effect of capsular decompression (CD) on odds of AVN in unstable SCFE. METHODS: Medline, Embase, and Cochrane databases were systematically searched for comparative studies investigating AVN rates in unstable SCFE treated with or without CD (aspiration, percutaneous, or open). Quality was evaluated by the Newcastle Ottawa Scale. A comparative analysis with pooled effect estimates using random-effects modeling was calculated. Secondary analysis pooled AVN rates from both comparative studies and case series. RESULTS: Comparative analysis included 17 retrospective studies with 453 hips (201 with CD, 252 without CD). Thirty-four of 201 (17%) hips with CD developed AVN, while 67 of 252 (27%) hips without CD developed AVN. The odds of AVN for patients treated with or without CD [odds ratio=0.80, 95% confidence interval (CI): 0.48-1.35] was not statistically different. Subanalysis on patients treated with in situ pinning or positional reduction and pinning showed no difference in AVN rates with or without CD (odds ratio=0.97, 95% CI: 0.44-2.10). In the secondary analysis of 17 comparative studies and 23 case series, the average rate of AVN was 17%, 0.17 (95% CI: 0.13-0.23) for patients treated with CD (60/447 hips) and 28%, 0.28 (95% CI: 0.22-0.35) for patients treated without CD (129/464 hips). CONCLUSIONS: There was no statistically significant decrease in odds of AVN with CD. However, studies were limited by their retrospective nature and inadequate documentation of CD techniques; the majority lacked femoral head blood flow monitoring to demonstrate adequate decompression. Future prospective studies with carefully documented complete decompression may help to elucidate the effect of CD on AVN risk. Although there was no statistically different odds of AVN with or without CD, even this large meta-analysis was underpowered, and one cannot conclude that there was truly no difference in odds of AVN without an appropriately powered study. Therefore, we recommend routine CD for all unstable SCFEs pending additional research, as CD adds little to the surgical procedure and may minimize the risk of a devastating insult to the femoral head.

Biomechanical Comparison of Suture-External Button Fixation vs Internal Suspension Fixation for Tendon Transfers of the Feet.

BACKGROUND: Fixation of tendon transfers in pediatric feet typically involves passing a suture that is secured to a tendon, through an intraosseous tunnel, and tying it over an external button on the plantar foot, with appropriate tension. After adequate time is allowed for bone-tendon healing, the suture and button are removed. This construct can be complicated by suture breakage with loss of fixation, and/or skin ulceration under the button. Internal suspension systems of tendons and ligaments in adults have demonstrated excellent fixation strength and minimal intraosseous tunnel displacement, with no risk of skin ulceration and no need for suture and button removal. This study compared the biomechanical properties of the suture-external button and internal suspension fixation techniques in cadavers. The primary outcome and secondary outcomes were displacement of suture-fixation construct during dynamic loading, and static loading, respectively. METHODS: Nine adult cadaver feet were obtained. Both the external button and internal suspension techniques were tested once in each cadaver, in random order. Relative displacement of the fixation construct within the bone tunnel was recorded with video capture during dynamic and static loading. A custom Matlab script processed video and materials testing data. Static and cyclic displacements were analyzed between fixation groups using a paired t test (alpha value =0.05). RESULTS: Internal suspension fixation had significantly less mean displacement of the tendon within the bone tunnel than the external button technique during dynamic (0.3 mm internal suspension system, 0.7 mm external button, P = .0115) and static loading (0.4 mm internal suspension system, 2.2 mm external button, P = .0019). CONCLUSIONS: Internal suspension systems may provide superior fixation compared to the traditional external button for tendon transfers, with the added benefit of avoiding the risk of skin ulceration and the need for suture and button removal. CLINICAL RELEVANCE: It appears internal suspension method of tendon transfer fixation would be an acceptable alternative to traditional methods of fixation with an external button.

Association Between Government Health Insurance Status and Physical Activity in American Youth.

BACKGROUND: Health insurance plans provide health programming access and affect physical activity levels in American youth, leading to health disparities in American children. The primary purpose of the current study was to investigate the relationship between health insurance status and physical activity level in American youth. METHODS: A national, United States census weighted cross-sectional survey was performed analyzing 2002 noninstitutionalized children living in the United States between the ages of 10 to 18 years, equally split by age and sex, with state of residency and race/ethnicity proportional to the 2010 census distribution. Multiple linear regression was performed to investigate the relationship between insurance status and activity level (measured by HSS Pedi-FABS activity score) while controlling for relevant demographic and socioeconomic covariables. RESULTS: HSS Pedi-FABS activity scores were normally distributed with a mean of 15.4±8.5 points (of 30 possible points). Patients with an insurance status of "government/Medicaid," "other," or "none" each demonstrated significantly lower physical activity scores (14.2±8.5 vs. 13.6±9.0 vs. 10.1±8.5) than children with private insurance (16.5±8.2) (one-way ANOVA with Dunnett-adjusted pairwise comparisons, P<0.001), which remained statistically significant while controlling for Area Deprivation Index, age, gender, race/ethnicity, and Body Mass Index (ß=-1.8, P<0.001). CONCLUSIONS: Government/Medicaid health insurance status and lack of health care coverage are associated with low levels of physical activity in American children, even while controlling for socioeconomic confounders. Collaborative work between health care providers and community/ school-based programs may be a reasonable approach to expanding access to recreation, organized sports, and physical activity for publicly and uninsured children. LEVEL OF EVIDENCE: Level II-Prognostic Study.

Adolescent and Caregiver-derived Utilities for Traumatic Patella Dislocation Health States.

INTRODUCTION: The treatment of a first-time traumatic patella dislocation in children and adolescents remains controversial. Preference-based health utility assessments can provide health-related quality of life information for orthopaedic conditions and their subsequent treatment. The purpose of this study was to determine utilities for pediatric acute traumatic patella dislocation and subsequent treatment health states from both children with patellar dislocation, and their parents. METHODS: Adolescents with acute first-time patella dislocations and their parents were identified. Six patella dislocation health states were defined: (1) Immediate post injury (Injury), (2) Postdislocation and nonoperative treatment with physical therapy (Rehabilitation), (3) Immediately poststabilization surgery (Postsurgical), (4) Recurrent dislocation after treatment (Recurrent dislocator), (5) Stable knee after initial treatment but unable to participate in sport at previous level (Stable return to lower function), and (6) Stable knee after initial treatment and fully able to participate in sport at previous level (Stable return to same function). Classic feeling thermometer utilities acquisition was performed, with self-report (patient) and proxy-report (parent) interviews performed separately. Patients' physical activity levels were collected using the UCLA Activity Score and the HSS Pedi-FABS. Comparisons between groups were made using Mann-Whitney U test and Wilcoxon signed-rank test. RESULTS: Ninety-five adolescents and 95 parents were included. Median (interquartile range) patient utilities for Injury, Rehabilitation, Postsurgical, Recurrent dislocator, Stable return to lower function, and Stable return to same function health states were: 25 (10 to 45), 50 (35 to 62.5), 30 (15 to 48.5), 20 (10 to 40), 70 (50 to 80), and 100 (100 to 100), respectively. Caregiver-derived utilities for children going through these health states were: 25 (10 to 49.5), 50 (25 to 60), 40 (15 to 60), 20 (5 to 40), 60 (50 to 77.5), and 100 (100 to 100). Stable return to a lower function was assigned a significantly higher utility by adolescents than their caregivers (P=0.03); highly active adolescents assigned a significantly higher utility to achieving a stable return to same function (P=0.02) while assigning significantly lower utility to health states in which they were not fully participating in sport. CONCLUSIONS: Adolescents and their parents felt that successful treatment of an acute patella dislocation was equivalent to perfect health (utility=1); however, adolescents assigned a significantly higher utility to a stable but lower functioning health state compared with their parents. Baseline functional status is an important modifier of health state preference-highly active adolescents assign a significantly greater disutility to health states in which they are not participating in sports at their regular level of play. These findings provide insight into the health-related quality of life impact for acute patella dislocations and their management, and potentially support minimizing time out of play and more aggressive treatment of first time acute patellar dislocations in athletic adolescents. LEVEL OF EVIDENCE: Level III.

Utilization of a Wide Array of Nonvalidated Outcome Scales in Pediatric Orthopaedic Publications: Can't We All Measure the Same Thing?

PURPOSE: Clinical changes are best evaluated with standardized, validated outcomes, including both patient-reported outcome measures and surgeon-reported outcome measures (PROMs and SROMs). The purpose of this study was to describe the spectrum of outcome measures used in pediatric orthopaedic publications over the past 10 years and to determine the proportion that are in fact age-appropriate, validated, and appropriately applied in terms of condition and population. METHODS: The Journal of Bone and Joint Surgery, The Bone and Joint Journal, Journal of Pediatric Orthopaedics A and B, and Journal of Children's Orthopaedics were systematically searched for studies including children aged 18 and below, over a 10-year period from January 2005 to December 2014. Economic evaluations, letters, editorials, review articles, and clinical guidelines were excluded. SROMs and PROMs used were extracted, as were details on subject age and condition for which they were used. Each outcome scale was assessed for validity, and the proportion of scales used appropriately was calculated. Cochrane-Armitage test of trend was used to determine changes in PROM and SROM utilization over the study period. RESULTS: A total of 4614 articles were identified, of which 2251 met inclusion and exclusion criteria. In total, 259 (11.5%) of studies used a PROM, whereas 326 (14.5%) used a SROM. A total of 230 different outcome scales were identified; 115 were patient reported and 115 were surgeon reported. However, only 18.7% of SROMs and 38.3% of PROMs were applied to an age and disease-appropriate demographic. Overall, there was a significant increase in the overall utilization of PROMs during the study period (P=0.004), but no corresponding increase in pediatric-validated PROMs (P=0.164). SROM utilization did not significantly change over the study period (P=0.337). CONCLUSIONS: Within the field of pediatric orthopaedics, an expansive variety of outcome scales are used, many of which have not been validated in children. Improved uniformity in reporting of outcomes and use of disease and age-validated outcomes scales is essential to improve multicenter research collaboration and data quality to generate appropriate evidence-based conclusions and treatment strategies in pediatric orthopaedics. LEVEL OF EVIDENCE: Level IV-systematic review.

The Root-Ely Modified Test of Rectus Femoris Spasticity Has Reliability in Individuals with Cerebral Palsy.

BACKGROUND: Stiff-knee gait is a common gait deviation in individuals with cerebral palsy (CP) due to rectus femoris (RF) muscle spasticity. The Duncan-Ely test is a velocity-dependent measurement of spasticity that is recorded as positive or negative. At our institution, we use a modification of the Duncan-Ely test, a 5-point ordinal rating scale, which delineates where the catch occurs within the rapid arc of knee flexion. It has been named the Root-Ely test. QUESTIONS/PURPOSES: We sought to determine the intra- and inter-rater reliability of the Duncan-Ely and Root-Ely tests in pediatric patients with CP. METHODS: A convenience sample of 20 ambulatory subjects was recruited; mean age was 10.5 ± 4.5 years, and the Gross Motor Function Classification System (GMFCS) levels were I-III. Five clinicians measured each individual's RF spasticity using the Root-Ely protocol during a single visit. Simple κ statistics with 95% confidence intervals (CI) were utilized for intra-rater reliability and weighted κ statistics with 95% CI for inter-rater reliability. RESULTS: The Root-Ely scale intra-rater reliability was 0.77 to 0.90 and inter-rater reliability was 0.32 to 0.87. Inter-rater reliability was good to excellent among experienced clinicians and fair to moderate in new clinicians. CONCLUSION: The Root-Ely 5-point scale has acceptable intra- and inter-rater reliability in pediatric individuals with CP among experienced clinicians. The Root-Ely test allows experienced clinicians to reliably quantify severity of RF spasticity and may give orthopaedic surgeons a clinical tool to better predict ideal candidates for RF transfers in individuals with CP in order to improve stiff-knee gait.

The Fragility of Statistically Significant Results in Pediatric Orthopaedic Randomized Controlled Trials as Quantified by the Fragility Index: A Systematic Review.

BACKGROUND: The randomized controlled trial (RCT) is the gold standard study design allowing critical comparison of clinical outcomes while minimizing bias. Traditionally clinical trials are evaluated through statistical significance, expressed by P-values and confidence intervals. However, until recently, the robustness of a study's conclusions has been given little attention. A new metric, the fragility index, quantifies the number of patients theoretically required to switch outcomes in order to reverse the study conclusions. The primary aim of our work was to determine the fragility index of RCTs in the pediatric orthopaedic literature. The secondary aim was to determine study factors associated with lower fragility index. METHODS: Pubmed and Embase were systematically searched for pediatric orthopaedic RCTs published September 1, 2006 to September 1, 2016. Two independent reviewers screened titles, abstracts, and manuscripts to identify studies published in English involving 2 treatment arms. Trials without dichotomous primary or secondary outcomes or with patients >18 years were excluded. Data were extracted from each eligible article in duplicate and the fragility index was determined using Fisher exact test, with previously published methods. Univariate analysis was used to determine factors associated with lower fragility index. RESULTS: Seventeen trials were eligible for inclusion. The median treatment arm size was 58 and overall sample size was 116 patients. The median fragility index was 3 (range, 0 to 18). A fragility index of 3 means that just 3 patients would need to switch treatment outcomes in order for the trial results to become statistically nonsignificant. In 1 study, the number of patients lost to follow-up exceeded the fragility index, such that the study conclusions could be completely reversed purely depending on the outcomes of the patients lost to follow-up. Lower fragility index was associated with smaller patient sample sizes and greater P-values. CONCLUSIONS: The fragility index is a useful adjunct metric to the P-value and confidence intervals, allowing analysis of the robustness of study conclusions. RCTs in pediatric orthopaedics often have small sample sizes, many with low fragility indices. Future efforts could focus on encouraging institutional collaboration and patient recruitment with the ultimate goal of improving RCT sample sizes, and potentially improving the robustness of RCT results. LEVEL OF EVIDENCE: Level I.

Clubfoot Etiology: A Meta-Analysis and Systematic Review of Observational and Randomized Trials.

BACKGROUND: Clubfoot is a common congenital anomaly with multiple potential risk factors. Identification of modifiable risk factors may minimize future incidence of clubfoot. The aim of this meta-analysis was to systematically review and analyze the best clinical evidence regarding risk factors associated with clubfoot. METHODS: Medline, Embase, and Cochrane databases were systematically searched from 1967 to May 11, 2016 for studies reporting risk factors for clubfoot. Randomized trials and observational studies were eligible for inclusion, and assessed in duplicate. Study quality was assessed with the Newcastle-Ottawa Scale or Cochrane risk of bias tool; low quality studies were excluded, all randomized trials were included. Two reviewers extracted data independently. This meta-analysis was conducted in accordance with PRISMA guidelines. Pooled effect estimates for the odds of clubfoot were calculated using random or fixed-effects models based on heterogeneity. RESULTS: Forty-two studies (28 case-control, 10 cohort, 4 randomized trials) comprising 31,844 clubfoot cases and 6,604,013 controls were included. Risk factors associated with increased odds of clubfoot included maternal smoking [odds ratio (OR)=1.65; 95% confidence interval (CI), 1.54-1.78], paternal smoking (OR=1.72; 95% CI, 1.05-2.84), maternal body mass index >30 (OR=1.46; 95% CI, 1.29-1.65), family history (OR=7.80; 95% CI, 4.04-15.04), amniocentesis (OR=2.08; 95% CI, 1.34-3.21), selective serotonin reuptake inhibitor exposure (OR=1.78; 95% CI, 1.34-2.37) maternal single status (OR=1.17; 95% CI, 1.11-1.23), gestational diabetes (OR=1.40; 95% CI, 1.13-1.72), nulliparity (OR=1.32; 95% CI, 1.19-1.45), male sex (OR=1.68; 95% CI, 1.48-1.94), and aboriginal Australian race (OR=2.35; 95% CI, 1.63-3.38). CONCLUSIONS: Smoking, maternal obesity, family history, amniocentesis, and some selective serotonin reuptake inhibitor exposures are the most clinically relevant exposures associated with increased odds of clubfoot, with family history representing the greatest risk. Recognition of modifiable risk factors may help in counseling patients, and minimizing clubfoot incidence. LEVEL OF EVIDENCE: Level II.

Bariatric Surgery Improves Outcomes After Lower Extremity Arthroplasty in the Morbidly Obese: A Propensity Score-Matched Analysis of a New York Statewide Database.

BACKGROUND: The purpose of this study was to compare risks for revision and short-term complications after total joint arthroplasty (TJA) in matched cohorts of morbidly obese patients, receiving and not receiving prior bariatric surgery. METHODS: Patients undergoing elective TJA between 1997 and 2011 were identified in a New York Statewide database, analyzing total knee arthroplasty (TKA) and total hip arthroplasty (THA) separately. Propensity scores were used to match morbidly obese patients receiving and not receiving bariatric surgery prior to TJA. Cox proportional hazard modeling assessed revision risk. Logistic regression evaluated odds for complications. RESULTS: For TKA, 2636 bariatric surgery patients were matched to 2636 morbidly obese patients. For THA, 792 bariatric surgery patients were matched to 792 morbidly obese patients. Matching balanced all covariates. Bariatric surgery reduced co-morbidities prior to TJA (TKA P < .0001; THA P < .005). Risks for in-hospital complications were lower for THA and TKA patients receiving prior bariatric surgery (odds ratio [OR] 0.25, P < .001; and OR = 0.69, P = .021, respectively). Risks for 90-day complications were lower for TKA (OR 0.61, P = .002). Revision risks were not different for either THA (P = .634) or TKA (P = .431), nor was THA dislocation risk (P = 1.000). CONCLUSION: After accounting for relevant selection biases, bariatric surgery prior to TJA was associated with reduced co-morbidity burden at the time of TJA and with reduced post-TJA complications. However, bariatric surgery did not reduce the risk for revision surgery for either TKA or THA.

Developmental dysplasia of the hip: an update on diagnosis and management from birth to 6 months.

PURPOSE OF REVIEW: Our understanding of the epidemiology, diagnosis, and management of developmental dysplasia of the hip (DDH) is evolving. This review focuses on the most up-to-date literature on DDH in patients from birth to six months of age. RECENT FINDINGS: Well known risk factors for DDH include family history, female sex, and breech positioning. Recent evidence suggests higher birth weight is a risk, whereas prematurity may be protective. Screening includes physical examination of all infant hips and imaging when abnormal findings or risk factors are present. Treatment in the first six months consists of a harness, with 70-95% success. Failure risk factors include femoral nerve palsy, static bracing, irreducible hips, initiation after seven weeks of age, right hip dislocation, Graf-IV hips, and male sex. Rigid bracing may be trialed if reduction with a harness fails and closed reduction is indicated after failed bracing. If the hip is still irreducible, nonconcentric, or unstable, open reduction may be required following closed reduction. Evidence does not support delaying hip reduction until the ossific nucleus is present. SUMMARY: DDH affects 1-7% of infants. All infants should be examined and selective screening with imaging should be performed for abnormal physical exams or risk factors. Early treatment is associated with optimal outcomes.

Reliability of the Modified Clavien-Dindo-Sink Complication Classification System in Pediatric Orthopaedic Surgery.

BACKGROUND: There is no standardized complication classification system that has been evaluated for use in pediatric or general orthopaedic surgery. Instead, subjective terms such as major and minor are commonly used. The Clavien-Dindo-Sink complication classification system has demonstrated high interrater and intrarater reliability for hip-preservation surgery and has increasingly been used within other orthopaedic subspecialties. This classification system is based on the magnitude of treatment required and the potential for each complication to result in long-term morbidity. The purpose of the current study was to modify the Clavien-Dindo-Sink system for application to all orthopaedic procedures (including those involving the spine and the upper and lower extremity) and to determine interrater and intrarater reliability of this modified system in pediatric orthopaedic surgery cases. METHODS: The Clavien-Dindo-Sink complication classification system was modified for use with general orthopaedic procedures. Forty-five pediatric orthopaedic surgical scenarios were presented to 7 local fellowship-trained pediatric orthopaedic surgeons at 1 center to test internal reliability, and 48 scenarios were then presented to 15 pediatric orthopaedic surgeons across the United States and Canada to test external reliability. Surgeons were trained to use the system and graded the scenarios in a random order on 2 occasions. Fleiss and Cohen kappa (κ) statistics were used to determine interrater and intrarater reliabilities, respectively. RESULTS: The Fleiss κ value for interrater reliability (and standard error) was 0.76 ± 0.01 (p < 0.0001) and 0.74 ± 0.01 (p < 0.0001) for the internal and external groups, respectively. For each grade, interrater reliability was good to excellent for both groups, with an overall range of 0.53 for Grade I to 1 for Grade V. The Cohen κ value for intrarater reliability was excellent for both groups, ranging from 0.83 (95% confidence interval [CI], 0.71 to 0.95) to 0.98 (95% CI, 0.94 to 1.00) for the internal test group and from 0.83 (95% CI, 0.73 to 0.93) to 0.99 (95% CI, 0.97 to 1.00) for the external test group. CONCLUSIONS: The modified Clavien-Dindo-Sink classification system has good interrater and excellent intrarater reliability for the evaluation of complications following pediatric orthopaedic upper extremity, lower extremity, and spine surgery. Adoption of this reproducible, reliable system as a standard of reporting complications in pediatric orthopaedic surgery, and other orthopaedic subspecialties, could be a valuable tool for improving surgical practices and patient outcomes.

Percutaneous Epiphysiodesis Using Transphyseal Screws: a Case Series Demonstrating High Efficacy.

BACKGROUND: Percutaneous epiphysiodesis using transphyseal screws (PETS) has been associated with implant failure, implant prominence, angular deformities, and delayed growth inhibition. QUESTIONS/PURPOSES: The aim of this study was to assess the complication rate and efficacy (defined as actual growth inhibition divided by expected growth inhibition) of PETS and to identify factors associated with improved efficacy. METHODS: Patients who underwent distal femoral and/or proximal tibial PETS between January 2007 and June 2014 were identified. Complications, efficacy, and final limb-length discrepancy (LLD) were calculated using multipliers and inhibition rates based on previous growth. Associations between efficacy and screw insertion angle (SIA), body mass index, and number of threads crossing the physis were calculated. RESULTS: Eight-two patients (126 treated physes) were included. The mean pre-operative LLD was 27.7 mm (SD = 7.5). Following epiphysiodesis, 15 had temporary pain (18%), five had temporary effusion (6.1%), four had broken implants (4.9%), four developed mild angulation (4.9%), and three had failed epiphysiodesis requiring revision (3.7%). Thirty-one underwent screw removal (n = 31, 38%). Mean LLD at maturity was 17.3 mm (SD = 5.8 mm). Mean efficacy at the distal femur was 97% (SD = 46%), at the proximal tibia was 108% (SD = 66%) and was 103% (SD = 57%) overall. Increased screw threads across the lateral proximal tibial physis (Spearman's correlation coefficient = 0.67; 95% CI = 0.40-0.94) and higher BMI (Spearman's correlation coefficient = 0.55; 95% CI = 0.34-0.77) were positively associated with increased efficacy. CONCLUSIONS: The efficacy of PETS may be more favorable than previously reported. Only 3.7% had serious complications requiring revision epiphysiodesis, lower than previous reports. Attention to sufficient screw threads across the physis may be important in optimizing PETS results.

Reliability and Reproducibility of Subject Positioning with EOS Low-Dose Biplanar X-ray.

BACKGROUND: EOS low-dose biplanar X-ray used with tantalum bead implantation is an appealing imaging modality to evaluate limb length and physeal growth due its relatively low radiation exposure, excellent inter- and intra-observer reliability, and minimal magnification/shrinkage error. QUESTIONS/PURPOSES: The purpose of this study was to establish the error in total length and inter-bead distances using EOS and tantalum beads due to variable positioning in the EOS gantry, by assessing variation in measurements made on the same subject repeatedly positioning by one positioner (intra-positioner measurement error) and variation in measurements made on the same subject with positioning by multiple positioners (inter-positioner measurement error). METHODS: Tantalum bead markers were placed about the distal femoral physis of a cadaveric lamb femur. Three investigators positioned the femur in the EOS gantry 10 times, totaling 30 EOS scans. Total limb length and inter-bead distances were measured on AP and lateral views; mean and standard error were calculated. A random effects analysis of variance for nested data was used to determine the proportion of variation due to differences between positioners and differences between positioning by the same positioner. RESULTS: Intra-positioner measurement error ranged from 0.01 to 0.06 mm. Inter-positioner measurement error ranged from 0.00 to 0.09 mm. CONCLUSIONS: EOS has relatively low radiation and allows standing assessment of limb length and alignment. In this study, length measurements and inter-bead distances demonstrated minimal error due to positioning in the EOS gantry, documenting that there is minimal error from positioning, minimal magnification/shrinkage error, and exceptional inter and intra-rater reliability. EOS is the preferred method for length and angular measurements, and with tantalum beads, is ideal for measuring growth about the physis.