Remote diagnostic imaging using artificial intelligence for diagnosing hip dysplasia in infants: Results from a mixed-methods feasibility pilot study.

Objectives: Infant hip dysplasia or Developmental Dysplasia of the Hip (DDH) occurs in 1-2% of births worldwide and leads to hip arthritis if untreated. We sought to evaluate the feasibility of implementing an artificial intelligence-enhanced portable ultrasound tool for infant hip dysplasia (DDH) screening in primary care, through determining its effectiveness in practice and evaluating patient and provider feedback. Methods: A US-FDA-cleared artificial intelligence (AI) screening device for DDH (MEDO-Hip) was added to routine well-child visits from age 6 to 10 weeks. A total of 306 infants were screened during a 1-year pilot study within three family medicine clinics in Alberta, Canada. Patient and provider satisfaction were quantified using the System Usability Survey (SUS), while provider perceptions were further investigated through semi-structured interviews. Results: Provider and user surveys commonly identified best features of the tool as immediate diagnosis, offering reassurance/knowledge and avoiding travel, and noted technical glitches most frequently as a barrier. A total of 369 scans of 306 infants were performed from Feb 1, 2021 until Mar 31, 2022. Eighty percent of hips scanned were normal on initial scans, 14% of scans required a follow-up study in the primary care clinic, and DDH cases were identified and treated at the expected 2% rate (6 infants). Conclusions: It is feasible to implement a point-of-care ultrasound AI screening tool in primary care to screen for infants with DDH. Beyond improved screening and detection, this innovation was well accepted by patients and fee-for-service providers with a culture and history of innovation.

AI aided workflow for hip dysplasia screening using ultrasound in primary care clinics.

Developmental dysplasia of the hip (DDH) is a common cause of premature osteoarthritis. This osteoarthritis can be prevented if DDH is detected by ultrasound and treated in infancy, but universal DDH screening is generally not cost-effective due to the need for experts to perform the scans. The purpose of our study was to evaluate the feasibility of having non-expert primary care clinic staff perform DDH ultrasound using handheld ultrasound with artificial intelligence (AI) decision support. We performed an implementation study evaluating the FDA-cleared MEDO-Hip AI app interpreting cine-sweep images obtained from handheld Philips Lumify probe to detect DDH. Initial scans were done by nurses or family physicians in 3 primary care clinics, trained by video, powerpoint slides and brief in-person. When the AI app recommended follow-up (FU), we first performed internal FU by a sonographer using the AI app; cases still considered abnormal by AI were referred to pediatric orthopedic clinic for assessment. We performed 369 scans in 306 infants. Internal FU rates were initially 40% for nurses and 20% for physicians, declining steeply to 14% after ~ 60 cases/site: 4% technical failure, 8% normal at sonographer FU using AI, and 2% confirmed DDH. Of 6 infants referred to pediatric orthopedic clinic, all were treated for DDH (100% specificity); 4 had no risk factors and may not have otherwise been identified. Real-time AI decision support and a simplified portable ultrasound protocol enabled lightly trained primary care clinic staff to perform hip dysplasia screening with FU and case detection rates similar to costly formal ultrasound screening, where the US scan is performed by a sonographer and interpreted by a radiologist/orthopedic surgeon. This highlights the potential utility of AI-supported portable ultrasound in primary care.

Normal variation of infant hip development : patterns revealed by 3D ultrasound.

AIMS: Studies of infant hip development to date have been limited by considering only the changes in appearance of a single ultrasound slice (Graf's standard plane). We used 3D ultrasound (3DUS) to establish maturation curves of normal infant hip development, quantifying variation by age, sex, side, and anteroposterior location in the hip. METHODS: We analyzed 3DUS scans of 519 infants (mean age 64 days (6 to 111 days)) presenting at a tertiary children's hospital for suspicion of developmental dysplasia of the hip (DDH). Hips that did not require ultrasound follow-up or treatment were classified as 'typically developing'. We calculated traditional DDH indices like α angle (αSP), femoral head coverage (FHCSP), and several novel indices from 3DUS like the acetabular contact angle (ACA) and osculating circle radius (OCR) using custom software. RESULTS: α angle, FHC, and ACA indices increased and OCR decreased significantly by age in the first four months, mean αSP rose from 62.2° (SD 5.7°) to 67.3° (SD 5.2°) (p < 0.001) in one- to eight- and nine- to 16-week-old infants, respectively. Mean αSP and mean FHCSP were significantly, but only slightly, lower in females than in males. There was no statistically significant difference in DDH indices observed between left and right hip. All 3DUS indices varied significantly between anterior and posterior section of the hip. Mean 3D indices of α angle and FHC were significantly lower anteriorly than posteriorly: αAnt = 58.2° (SD 6.1°), αPost = 63.8° (SD 6.3°) (p < 0.001), FHCAnt = 43.0 (SD 7.4), and FHCPost = 55.4° (SD 11.2°) (p < 0.001). Acetabular rounding measured byOCR indices was significantly greater in the anterior section of the hip (p < 0.001). CONCLUSION: We used 3DUS to show that hip shape and normal growth pattern vary significantly between anterior and posterior regions, by magnitudes similar to age-related changes. This highlights the need for careful selection of the Graf plane during 2D ultrasound examination. Whole-joint evaluation by obtaining either 3DUS or manual 'sweep' video images provides more comprehensive DDH assessment.Cite this article: Bone Jt Open 2022;3(11):913-923.

Interobserver Variability of Hip Dysplasia Indices on Sweep Ultrasound for Novices, Experts, and Artificial Intelligence.

BACKGROUND: Ultrasound for developmental dysplasia of the hip (DDH) is challenging for nonexperts to perform and interpret. Recording "sweep" images allows more complete hip assessment, suitable for automation by artificial intelligence (AI), but reliability has not been established. We assessed agreement between readers of varying experience and a commercial AI algorithm, in DDH detection from infant hip ultrasound sweeps. METHODS: We selected a full spectrum of poor-to-excellent quality images and normal to severe dysplasia, in 240 hips (120 single 2-dimensional images, 120 sweeps). For 12 readers (radiologists, sonographers, clinicians and researchers; 3 were DDH subspecialists), and a ultrasound-FDA-cleared AI software package (Medo Hip), we calculated interobserver reliability for alpha angle measurements by intraclass correlation coefficient (ICC2,1) and for DDH classification by Randolph Kappa. RESULTS: Alpha angle reliability was high for AI versus subspecialists (ICC=0.87 for sweeps, 0.90 for single images). For DDH diagnosis from sweeps, agreement was high between subspecialists (kappa=0.72), and moderate for nonsubspecialists (0.54) and AI (0.47). Agreement was higher for single images (kappa=0.80, 0.66, 0.49). AI reliability deteriorated more than human readers for the poorest-quality images. The agreement of radiologists and clinicians with the accepted standard, while still high, was significantly poorer for sweeps than 2D images (P<0.05). CONCLUSIONS: In a challenging exercise representing the wide spectrum of image quality and reader experience seen in real-world hip ultrasound, agreement on DDH diagnosis from easily obtained sweeps was only slightly lower than from single images, likely because of the additional step of selecting the best image. AI performed similarly to a nonsubspecialist human reader but was more affected by low-quality images.

Physician wellness in orthopaedic surgery : a multinational survey study.

AIMS: Physician burnout and its consequences have been recognized as increasingly prevalent and important issues for both organizations and individuals involved in healthcare delivery. The purpose of this study was to describe and compare the patterns of self-reported wellness in orthopaedic surgeons and trainees from multiple nations with varying health systems. METHODS: A cross-sectional survey of 774 orthopaedic surgeons and trainees in five countries (Australia, Canada, New Zealand, UK, and USA) was conducted in 2019. Respondents were asked to complete the Mayo Clinic Well-Being Index and the Stanford Professional Fulfillment Index in addition to 31 personal/demographic questions and 27 employment-related questions via an anonymous online survey. RESULTS: A total of 684 participants from five countries (Australia (n = 74), Canada (n = 90), New Zealand (n = 69), UK (n = 105), and USA (n = 346)) completed both of the risk assessment questionnaires (Mayo and Stanford). Of these, 42.8% (n = 293) were trainees and 57.2% (n = 391) were attending surgeons. On the Mayo Clinic Well-Being Index, 58.6% of the overall sample reported feeling burned out (n = 401). Significant differences were found between nations with regards to the proportion categorized as being at risk for poor outcomes (27.5% for New Zealand (19/69) vs 54.4% for Canada (49/90) ; p = 0.001). On the Stanford Professional Fulfillment Index, 38.9% of the respondents were classified as being burned out (266/684). Prevalence of burnout ranged from 27% for Australia (20/74 up to 47.8% for Canadian respondents (43/90; p = 0.010). Younger age groups (20 to 29: RR 2.52 (95% confidence interval (CI) 1.39 to 4.58; p = 0.002); 30 to 39: RR 2.40 (95% CI 1.36 to 4.24; p = 0.003); 40 to 49: RR 2.30 (95% CI 1.35 to 3.9; p = 0.002)) and trainee status (RR 1.53 (95% CI 1.15 to 2.03 p = 0.004)) were independently associated with increased relative risk of having a 'at-risk' or 'burnout' score. CONCLUSIONS: The rate of self-reported burnout and risk for poor outcomes among orthopaedic surgeons and trainees varies between countries but remains unacceptably high throughout. Both individual and health system characteristics contribute to physician wellness and should be considered in the development of strategies to improve surgeon wellbeing. Level of Evidence: III Cite this article: Bone Jt Open 2021;2(11):932-939.

Functional characterization of plantar pressure patterns in gait of typically developing children using dynamic pedobarography.

BACKGROUND: Abnormal foot posture is a common complaint presented in pediatric and pediatric orthopedic clinics. Functional, objective assessment of foot posture, with the potential for early identification of pathologic foot deformities, has, however, been lacking to date. While quantifying functional and regional impulses via dynamic pedobarography can improve the clinical assessment of children's feet, normative values have not yet been reported or characterized. RESEARCH QUESTION: The objectives of this study were to: (1) quantify and characterize the pattern and spectrum of foot impulses in walking-aged, typically developing children; and (2) compare these to impulses from non-disabled adults. METHODS: Foot impulses of 102 participants (52 female) in five pre-determined age groups (2-3, 4-6, 7-10, 11-14, 15-17 years) were examined using dynamic pedobarography. Each pressure map (3 per foot per child) was divided according to anatomical foot regions: the hallux, heel, medial forefoot, lateral forefoot, lesser toes (D2 to D5), and midfoot. The impulse was calculated for each region and used to generate regional percent impulses and impulse ratios to assess anteroposterior and mediolateral balance within the foot. RESULTS: The impulse through the midfoot was highest in the youngest age group, with a corresponding lower impulse through the medial forefoot. As age advanced, the midfoot impulse decreased (p = 0.001), and the forefoot balance shifted slightly more medially (%Medial Forefoot: p = 0.004; Medial-Lateral Forefoot Balance: p = 0.019). When compared to adults, there were no significant differences between 15-17 year old children and adults in any of the regional percent impulses and impulse ratios. This indicates that skeletal maturity of the foot by late adolescence results in functional characteristics seen in adults. SIGNIFICANCE: The age-standardized norms of functional and regional impulse measures in children reported in this study can be used as a comparative benchmark in the clinical assessment of children presenting with various foot deformities.

Prediction of mechanical behavior of cartilaginous infant hips in pavlik harness: A subject-specific simulation study on normal and dysplastic hips.

In dysplastic infant hips undergoing abduction harness treatment, cartilage contact pressure is believed to have a role in therapeutic cartilage remodeling and also in the complication of femoral head avascular necrosis. To improve our understanding of the role of contact pressure in the remodeling and the complication, we modeled cartilage contact pressure in cartilaginous infant hips undergoing Pavlik harness treatment. In subject-specific finite element modeling, we simulated contact pressure of normal and dysplastic hips in Pavlik harness at 90° flexion and gravity-induced abduction angles of 40°, 60° and 80°. We demonstrated that morphologies of acetabulum and femoral head both affected contact pressure distributions. The simulations showed that in Pavlik harness, contact pressure was mainly distributed along anterior and posterior acetabulum, leaving the acetabular roof only lightly loaded (normal hip) or unloaded (dysplastic hip). From a mechanobiological perspective, these conditions may contribute to therapeutic remodeling of the joint in Pavlik harness. Furthermore, contact pressure increased with the angle of abduction, until at the extreme abduction angle (80°), the lateral femoral head also contacted the posterior acetabular edge. Contact pressure in this area could contribute to femoral head avascular necrosis by reducing flow in femoral head blood vessels. The contact pressure we simulated can plausibly account for both the therapeutic effects and main adverse effect of abduction harness treatment for developmental dysplasia of the hip. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res.

Functional, impulse-based quantification of plantar pressure patterns in typical adult gait.

BACKGROUND: Dynamic pedobarography is used to measure the change in plantar pressure distribution during gait. Clinical methods of pedobarographic analysis lack, however, a standardized, functional segmentation or require costly motion capture technology and expertise. Furthermore, while commonly used pedobarographic measures are mostly based on peak pressures, progressive foot deformities also depend on the duration the pressure is applied, which can be quantified via impulse measures. RESEARCH QUESTION: Our objectives were to: (1) develop a standardized method for functionally segmenting pedobarographic data during gait without the need for motion capture; (2) compute pedobarographic measures that are based on each segment's vertical impulse; and (3) obtain a normative set of such pedobarographic measures for non-disabled gait. METHODS: Pedobarographic data was collected during gait from sixty adults with normal feet. Using the maximum pressure map for each trial, an expert and novice rater independently identified the hallux, heel, medial forefoot, and lateral forefoot and computed nine normalized vertical impulse measures. RESULTS: From the computed impulse measures, the Heel-to-Forefoot Balance was 33.3 ± 5.5%, the Medial-Lateral Forefoot Balance (with hallux) 59.2 ± 8.0%, the Medial-Lateral Forefoot Balance (without hallux) 53.5 ± 7.7%, and the Hallux-to-Medial Forefoot Balance 21.0 ± 8.9% (mean ± standard deviation). The intra- and inter-rater reliability ranged between 0.93 and 1.00 and between 0.89 and 0.99, respectively (ICC(2,1)). SIGNIFICANCE: We developed a simple, stand-alone method for pedobarographic segmentation that is mechanistically linked to relevant anatomical regions of the foot. The normative impulse measures exhibited excellent reliability. This normative dataset is currently used in the clinical assessment of different foot deformities and gait impairments, and in the evaluation of treatment outcomes.

Reliability of 2D and 3D ultrasound for infant hip dysplasia in the hands of novice users.

PURPOSE: Developmental dysplasia of the hip (DDH) diagnosis by two-dimensional ultrasound (2DUS) can have poor inter-rater reliability. 3D ultrasound (3DUS) may be more reliably performed, particularly by novice users. We compared intra- and inter-rater reliability between expert and novice operators performing 2DUS and 3DUS for DDH. MATERIALS AND METHODS: Infants with suspected DDH were assessed with 2DUS and 3DUS. Novice operators had 1.5 h of training and Experts had 5-15 years' experience. Images included two 2DUS static and two 3DUS sweep images per operator. Image quality was assessed by 5-point system (yes/no: full femoral head; full acetabular roof; horizontal iliac wing; os ischium; absent motion/artifact). 2DUS indices (alpha angle, coverage) were measured centrally by a blinded reader with 2 years DDH US experience. 3DUS was post-processed by semi-automated custom software generating acetabular surface models, indices and estimated probability of DDH. Gold-standard diagnosis of each hip as normal, borderline or dysplastic was based on radiologist review of expert 2DUS. RESULTS: Thirty infants, mean age 10.8 weeks were enrolled. Quality scores were 2.7±1.2 Novice versus 4.9±0.3 Expert for 2DUS (p = 0.04), and 4.2±1.0 Novice versus 4.9±0.3 Expert for 3DUS (p = 0.99). Inter-rater reliability was poor for 2DUS (ICC=0.10 for alpha angle, 0.04 for acetabular coverage) and moderate to high for 3DUS (ICC=0.73-0.83 for alpha angle, 0.55 for acetabular coverage). Intra-rater reliability and diagnostic accuracy was higher for 3DUS than 2DUS. CONCLUSION: Novice operators can perform 3DUS for DDH with reliability and accuracy approaching expert sonographers. Novices perform 2DUS with poor reliability and accuracy. KEY POINTS: • Novice/expert inter-rater reliability improved from poor with 2DUS to moderate/high with 3DUS. • Novice operators using 3DUS correctly classified 57/58 (98%) of infant hips. • DDH can be reliably assessed by novice operators using 3DUS.

The utility of normative foot floor angle data in assessing toe-walking.

Initial heel contact is an important attribute of gait, and failure to complete the heel rocker reduces gait stability. One common goal in treating toe-walking is to restore heel strike and prevent or reduce early heel rise. Foot floor angle (FFA) is a measure of toe-walking that is valuable for quantifying foot orientation at initial contact when using ankle dorsiflexion angle alone is misleading. However, no age-standardized FFA norms exist for clinical evaluation. Our objectives were to: (1) obtain normative FFA in typically developing children; and (2) examine its utility in the example of toe-walking secondary to unilateral cerebral palsy. Gait kinematics were acquired and FFA trajectories computed for 80 typically developing children (4-18 years). They were also obtained retrospectively from 11 children with toe-walking secondary to unilateral cerebral palsy (4-10 years), before and after operative intervention, and compared to 40 age-matched, typically developing children. FFA at initial contact was significantly different (P<.001) between pre-surgery toe-walking (-14.7±9.7°; mean±standard deviation) and typical gait (18.7±2.8°). Following operative lengthening of the gastrocnemius-soleus complex on the affected side, FFA at initial contact (-0.9±5.3°) was significantly improved (P<.001). Furthermore, several cases were identified for which the sole use of ankle dorsiflexion angle to capture toe-walking is misleading. The assessment of FFA is a simple method for providing valuable quantitative information to clinicians regarding foot orientation during gait. The demonstrated limitations of using ankle dorsiflexion angle alone to estimate foot orientation further emphasize the utility of FFA in assessing toe-walking.

Developmental Hip Dysplasia Diagnosis at Three-dimensional US: A Multicenter Study.

Purpose To validate accuracy of diagnosis of developmental dysplasia of the hip (DDH) from geometric properties of acetabular shape extracted from three-dimensional (3D) ultrasonography (US). Materials and Methods In this retrospective multi-institutional study, 3D US was added to conventional two-dimensional (2D) US of 1728 infants (mean age, 67 days; age range, 3-238 days) evaluated for DDH from January 2013 to December 2016. Clinical diagnosis after more than 6 months follow-up was normal (n = 1347), borderline (Graf IIa, later normalizing spontaneously; n = 140) or dysplastic (Graf IIb or higher, n = 241). Custom software accessible through the institution's research portal automatically calculated indexes including 3D posterior and anterior alpha angle and osculating circle radius from hip surface models generated with less than 1 minute of user input. Logistic regression predicted clinical diagnosis (normal = 0, dysplastic = 1) from 3D indexes (ie, age and sex). Output represented probability of hip dysplasia from 0 to 1 (output: >0.9, dysplastic; 0.11-0.89, borderline; <0.1, normal). Software can be accessed through the research portal. Results Area under the receiver operating characteristic curve was equivalently high for 3D US indexes and 2D US alpha angle (0.996 vs 0.987). Three-dimensional US helped to correctly categorize 97.5% (235 of 241) dysplastic and 99.4% (1339 of 1347) normal hips. No dysplastic hips were categorized as normal. Correct diagnosis was provided at initial 3D US scan in 69.3% (97 of 140) of the studies diagnosed as borderline at initial 2D US scans. Conclusion Automatically calculated 3D indexes of acetabular shape performed equivalently to high-quality 2D US scans at tertiary medical centers to help diagnose DDH. Three-dimensional US reduced the number of borderline studies requiring follow-up imaging by over two-thirds.

Primary Wound Closure After Open Fracture: A Prospective Cohort Study Examining Nonunion and Deep Infection.

OBJECTIVES: Determine the proportion of subjects developing deep infection or nonunion after primary wound closure of open fractures (humerus, radius/ulna, femur, and tibia/fibula). Secondarily, a matched-series analysis compared outcomes with subjects who underwent delayed wound closure. DESIGN: Prospective cohort between 2009 and 2013 of subjects undergoing primary closure. SETTING: Trauma center. PARTICIPANTS: Eighty-three (84 fractures) subjects were enrolled. Eighty-two (99%) subjects (83 fractures) provided follow-up data. Matching (age, sec, fracture location, and grade) was performed using study data of delayed wound closure undertaken at the same center between 2001 and 2009 (n = 68 matched subjects). INTERVENTION: Primary wound closure occurred when the fracture grade was Gustilo grade 3A or lower and the wound deemed clean at initial surgery. Standardized evaluations occurred until the fracture(s) healed; phone interviews and chart reviews were also undertaken at 1 year. MAIN OUTCOME MEASUREMENTS: Deep infection is defined as infection requiring unplanned surgical debridement and/or sustained antibiotic therapy after wound closure; nonunion is defined as unplanned surgical intervention after definitive wound closure or incomplete radiographic healing 1-year after fracture. RESULTS: Three (4%) subjects had deep infections, whereas 10 (12%) subjects developed nonunion in the primary closure cohort. In the matched analyses [n = 68 pairs; (136 subjects)], the primary closure cohort had fewer deep infections [n = 3 (4%) vs. n = 6 (9%)] and nonunions [n = 9 (13%) vs. n = 19 (29%)] than the delayed closure cohort (P < 0.001). CONCLUSIONS: Primary wound closure after an open fracture appears acceptable in appropriately selected patients and may reduce the risk of deep infection and nonunion compared with delayed closure; a definitive randomized trial is needed. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Cross-Modality Validation of Acetabular Surface Models Using 3-D Ultrasound Versus Magnetic Resonance Imaging in Normal and Dysplastic Infant Hips.

Current imaging diagnosis of developmental dysplasia of the hip (DDH) in infancy relies on 2-D ultrasound (US), which is highly operator-dependent. 3-D US offers more complete, and potentially more reliable, imaging of infant hip geometry. We sought to validate the fidelity of acetabular surface models obtained by 3-D US against those obtained concurrently by magnetic resonance imaging (MRI). 3-D US and MRI scans were performed on the same d in 20 infants with normal to severely dysplastic hips (mean age, 57 d; range 13-181 d). 3-D US was performed by two observers using a Philips VL13-5 probe. Coronal 3-D multi-echo data image combination (MEDIC) magnetic resonance (MR) images (1-mm slice thickness) were obtained, usually without sedation, in a 1.5 T Siemens unit. Acetabular surface models were generated for 40 hips from 3-D US and MRI using semi-automated tracing software, separately by three observers. For each hip, the 3-D US and MRI models were co-registered to overlap as closely as possible using Amira software, and the root mean square (RMS) distances between points on the models were computed. 3-D US scans took 3.2 s each. Inter-modality variability was visually minimal. Mean RMS distance between corresponding points on the acetabular surface at 3-D US and MRI was 0.4 ± 0.3 mm, with 95% confidence interval <1 mm. Mean RMS errors for inter-observer and intra-observer comparisons were significantly less for 3-D US than for MRI, while inter-scan and inter-modality comparisons showed no significant difference. Acetabular geometry was reproduced by 3-D US surface models within 1 mm of the corresponding 3-D MRI surface model, and the 3-D US models were more reliable. This validates the fidelity of 3-D US modeling and encourages future use of 3-D US in assessing infant acetabulum anatomy, which may be useful to detect and monitor treatment of hip dysplasia.

An index for diagnosing infant hip dysplasia using 3-D ultrasound: the acetabular contact angle.

BACKGROUND: Developmental dysplasia of the hip (DDH) is a common condition that is highly treatable in infancy but can lead to the lifelong morbidity of premature osteoarthritis if left untreated. Current diagnostic methods lack reliability, which may be improved by using 3-D ultrasound. OBJECTIVE: Conventional 2-D US assessment of DDH has limitations, including high inter-scan variability. We quantified DDH on 3-D US using the acetabular contact angle (ACA), a property of the 3-D acetabular shape. We assessed ACA reliability and diagnostic utility. MATERIALS AND METHODS: We prospectively collected data from January 2013 to December 2014, including 114 hips in 85 children divided into three clinical diagnostic groups: (1) normal, (2) initially borderline but ultimately normal without treatment and (3) dysplastic requiring treatment. Using custom software, two observers each traced acetabula twice on two 3-D US scans of each hip, enabling automated generation of 3-D surface models and ACA calculation. We computed inter-observer and inter-scan variability of repeatability coefficients and generated receiver operating characteristic (ROC) curves. RESULTS: The 3-D US acetabular contact angle was reproduced 95% of the time within 6° in the same scan and within 9° in different scans of the same hip, vs. 9° and 14° for the 2-D US alpha angle (P < 0.001). Areas under ROC curves for diagnosis of developmental dysplasia of the hip were 0.954 for ACA and 0.927 for alpha angle. CONCLUSION: The 3-D US ACA was significantly more reliable than 2-D US alpha angle, and the 3-D US measurement predicted the presence of DDH with slightly higher accuracy. The ACA therefore shows promising initial diagnostic utility. Our findings call for further study of 3-D US in the diagnosis and longer-term follow-up of infant hip dysplasia.

Factors Associated With Development of Nonunion or Delayed Healing After an Open Long Bone Fracture: A Prospective Cohort Study of 736 Subjects.

OBJECTIVES: To determine factors associated with developing nonunion or delayed healing after open fracture. DESIGN: Prospective cohort between 2001 and 2009. SETTING: Three level 1 Canadian trauma centers. PARTICIPANTS: Seven hundred thirty-six (791 fractures) subjects were enrolled. Six hundred eighty-nine (94%) subjects (739 fractures) provided adequate outcome data. INTERVENTION: Subjects were followed until fracture(s) healed; phone interviews and chart reviews were conducted 1 year after fracture. Patient, fracture, and injury information, and time to surgery and antibiotics were recorded during hospitalization. MAIN OUTCOME MEASUREMENTS: Nonunion defined as unplanned surgical intervention after definitive wound closure or incomplete radiographic healing at 1 year and delayed healing defined as 2 consecutive clinical assessments showing no radiographic progression or incomplete radiographic healing between 6 months and 1 year. RESULTS: There were 413 (52%) tibia/fibular, 285 (36%) upper extremity, and 93 (13%) femoral fractures. Nonunion developed in 124 (17%) and delayed healing in 63 (8%) fractures. The median time to surgery was not different for fractures that developed nonunion compared with those who did not (P = 0.36). Deep infection [Odd ratio (OR) 12.75; 95% confidence interval (CI) 6.07-26.8], grade 3A fractures (OR 2.49; 95% CI, 1.30-4.78), and smoking (OR 1.73; 95% CI, 1.09-2.76) were significantly associated with developing a nonunion. Delayed healing was also significantly associated with deep infection (OR 4.34; 95% CI, 1.22-15.48) and grade 3B/C fractures (OR 3.69; 95% CI, 1.44-9.44). Multivariate regression found no association between nonunion and time to surgery (P = 0.15) or antibiotics (P = 0.70). CONCLUSIONS: Deep infection and higher Gustilo grade fractures were associated with nonunion and delayed healing. LEVEL OF EVIDENCE: Prognostic Level I. See Instructions for Authors for a complete description of levels of evidence.

Does Topical Anesthetic Reduce Pain During Intraosseous Pin Removal in Children? A Randomized Controlled Trial.

BACKGROUND: The purpose of this study was to determine the effectiveness of topical liposomal lidocaine in reducing the pain perceived by children undergoing percutaneous intraosseous pin (PP) removal in the outpatient orthopaedic clinic. METHODS: A triple-blinded, randomized, placebo-controlled clinical trial comparing topical liposomal lidocaine to a placebo was conducted at the Stollery Children's Hospital between September 2008 and February 2011. Subjects undergoing the removal of PP in the orthopaedic outpatient clinic between ages 3 and 16 years were recruited. A computer-generated variable-block randomization scheme was used to determine each subject's group assignment. Pain was recorded just before randomization and immediately after the procedure using the Oucher Scale (for subjects) and a 10-cm Visual Analog Scale (for parents and an observing orthopaedic technician). In a subset of individuals, follow-up telephone calls were made 24 hours postprocedure to inquire about any adverse event from the use of the topical liposomal lidocaine. Data were analyzed using the Student t test. RESULTS: Of a total of 296 recruited subjects, complete data were available on 281 subjects (140 intervention and 141 control). There were no significant differences between the 2 groups with regards to baseline characteristics, including preprocedure pain scores. Although postprocedure pain scores demonstrated an increase in pain in both groups (2.3 points in the treatment group and 2.0 points in the placebo group), no statistically significant difference was seen in postprocedure pain scores between groups (P=0.81). No adverse events were observed or reported. CONCLUSIONS: Topically applied liposomal lidocaine was not effective in reducing pain during this procedure, compared with a placebo. However, this study demonstrates that PP removal is a painful procedure in children. Given the large volume of patients who undergo this procedure and the long-term consequences of experiencing painful procedures in childhood, it is important to find safe and fast-acting methods to decrease procedural pain associated with PP removal.

Reproducibility of Acetabular Landmarks and a Standardized Coordinate System Obtained from 3D Hip Ultrasound.

Two-dimensional (2D) ultrasound detection of developmental dysplasia of the hip (DDH) is limited by variation in acetabular appearance and alpha angle measurements, which change with position of the ultrasound probe. Three-dimensional (3D) ultrasound captures the entire acetabular shape, and a reproducible "standard central plane" may be generated, from two landmarks located on opposite ends of the acetabulum, for measurement of alpha angle and other indices. Two users identified landmarks on 51 3D ultrasounds, with ranging severity of disease, and inter- and intra-observer reproducibility of landmark and "standard plane" locations was compared; landmarks were chosen within 2 mm, and the "standard plane" rotation was reproducible within 10° between observers. We observed no difference in variability between alpha angles measured on the "standard plane" in comparison with 2D ultrasound. Applications of the standardized 3D ultrasound central plane will be to fuse serial ultrasounds for follow-up and development of new indices of 3D deformity.

Ultrasound quantification of acetabular rounding in hip dysplasia: reliability and correlation to treatment decisions in a retrospective study.

Currently, acetabular rounding is only subjectively assessed on ultrasound for developmental dysplasia of the hip. We tested whether acetabular rounding can be quantified reliably and can distinguish between hips requiring and not requiring treatment. Consecutive infants (n = 90) suspected of having dysplasia of the hip, seen at a pediatric orthopedic clinic, were separated into four diagnostic categories (normal, borderline but resolved, treated by brace, treated surgically). Acetabular rounding was assessed by semi-quantitative grade (0 = nil, 1 = mild, 2 = moderate, 3 = severe) by three observers and by direct measurement of acetabular radius of curvature (AROC) by two observers. Inter-observer reliability of rounding grade was poor (κ = 0.30-0.37). AROC had an inter-observer intra-class correlation coefficient of 0.84 and coefficient of variation of 29%-34%. Mean AROC was significantly higher for hips requiring treatment than for those not requiring treatment (3.3 mm vs. 1.6 mm, p = 0.007). AROC reliably quantifies an observation currently being made subjectively by radiologists and surgeons, and may be useful as a supplementary ultrasound index of dysplasia of the hip in future prospective studies.

The Quality of Randomized Controlled Trials in Pediatric Orthopaedics: Are We Improving?

PURPOSE: The quality of randomized controlled trials (RCTs) in orthopaedics is a topic of considerable importance, as RCTs play a major role in guiding clinical practice. The quality of RCTs published between 1995 and 2005 has previously been documented. The purpose of the current study was to assess and describe the quality of pediatric orthopaedic RCTs published from 2005 to 2012, by identifying study characteristics associated with higher quality and outlining areas for improvement. METHODS: A standardized literature search was used to identify pediatric orthopaedic RCTs published in 7 well-recognized journals between September 2005 and July 2012 inclusive. The Detsky Quality Assessment Scale and the CONSORT checklist for Non-Pharmacologic Trials were used to assess the quality of the RCTs. Scores for the Detsky and CONSORT were calculated by 2 independent blinded orthopaedic surgeon reviewers with epidemiologic training. RESULTS: Forty RCTs were included in this analysis. The mean percentage score on the Detsky quality scale was 67%. Sixteen (40%) of the articles satisfied the threshold for a satisfactory level of methodological quality (Detsky >75%). Twenty-five (63%) of these studies were negative studies, concluding no difference between treatment arms. In 52% of the negative studies, an a priori sample size analysis was absent, and 28% were self-described as underpowered. In multiple variable regression analysis, only working with a statistician was significantly associated with higher Detsky percentage scores (P=0.01). CONCLUSIONS: There is a trend for improving quality in pediatric orthopaedic RCTs. Compared with past reports, the mean Detsky score improved from 53% to 67%, and the proportion meeting an acceptable level of quality improved from 19% to 40%. One of the most concerning findings of this study was the lack of attention to sample size and power analysis, and the potential for underpowered studies. Ongoing efforts are necessary to improve the conduct and reporting of clinical trials in pediatric orthopaedics. SIGNIFICANCE: Pediatric orthopaedic surgeons, JPO, and POSNA are working toward improving levels of quality in pediatric orthopaedic research. This paper highlights progress that has been made, and addresses some high-yield areas for future improvement.