Pediatric Device Innovation: An Analysis of Food and Drug Administration Authorizations Over Time.

BACKGROUND: Despite a tremendous increase in the number of orthopaedic devices authorized by the U.S. Food and Drug Administration (FDA), novel devices designed specifically for the pediatric population remain sparse. Surgeons frequently repurpose adult implants for "off-label" use in pediatric patients, with both legal and technical ramifications. This study seeks to objectively quantify and characterize the nature of pediatric device innovation over time. METHODS: The FDA employs 4 pathways for assessing safety and effectiveness of novel devices prior to authorization. Perceived device risk and novelty determine the pathway. Orthopaedic devices were identified from the FDA's online database. All devices approved since inception via the Humanitarian Device Exemption, Pre-Market Approval, and De Novo regulatory pathways were included and grouped as "highly innovative." Because of their number and the rapidity of their development, the evaluation of 510(k) devices was limited to those cleared from January 1, 2018, to December 31, 2022. Such 510(k) devices make up ∼97% of devices and by definition are less risky and less novel. Approval statements were assessed for pediatric indications within the approved labeling. As a secondary analysis, the impact of company size on developing a product with a pediatric indication was analyzed. RESULTS: Of the 1,925 devices cleared via the 510(k) pathway, 9 (0.5%) were designed exclusively for pediatrics and 160 (8.3%) included pediatric indications. Five of the 9 pediatrics-only devices were for spine and 4 were for trauma indications. Of the 97 highly innovative devices, only 2 (2%) were exclusively pediatric and another 2 (2%) included pediatric indications. The 2 pediatrics-only devices were for the spine. Large and medium-sized companies were 1.9 times and 1.6 times more likely to bring to market a device with pediatric indications than a small company, respectively. CONCLUSIONS: Innovation for pediatric orthopaedic devices lags substantially behind that for adult orthopaedic devices. These findings are consistent with clinical experience and the common practice of modifying adult implants for "off-label" use in pediatric patients. Despite long-standing efforts to stimulate innovation for this vulnerable population, our results suggest little progress.

Pediatric Type I Open Both Bone Forearm Fractures: Predicting Failure of Nonoperative Management.

BACKGROUND: In recent years, nonoperative treatment of pediatric type I open both bone forearm fractures (OBBFFs) with bedside irrigation, antibiotics, closed reduction, and casting has yielded low infection rates. However, risk factors for failure of type I OBBFF closed reduction have not been well described. Our purpose was to describe management of patients with type I OBBFFs at our institution and determine what factors are associated with failure of closed reduction in this population. METHODS: This was a review of patients between 5 and 15 years of age who received initial nonoperative management for type I OBBFFs at one institution between 2015 and 2021. Primary outcome was success or failure of nonoperative management (defined as progression to surgical management). Secondary outcomes included infections, compartment syndromes, and neuropraxias. Other variables of interest were demographic information, prereduction and postreduction translation and angulation of the radius and ulna, cast index, and antibiotic administration. RESULTS: Sixty-one patients (67.7% male) with 62 type I OBBFFs were included in this study. Following initial nonoperative management, 55 injuries (88.7%) were successfully treated in casts, while the remaining 7 (11.3%) required surgical intervention following loss of acceptable reduction in cast. Median cast index (0.84, IQR 0.8 to 0.9 vs. 0.75, IQR 0.7-0.8, P =0.020) and postreduction radius translation on anteroposterior films (32.0%, IQR 17.0% to 40.0% vs. 5.0%, IQR 0.0% to 26.0%, P =0.020) were higher among those who failed nonoperative management. Multivariable logistic regression models identified increased odds of failure for every SD (0.7) increase in cast index (OR 3.78, P =0.023, 95% CI: 1.4-14.3) and 25% increase in postreduction radius translation on anteroposterior films (OR 7.39, P =0.044, 95% CI 1.2-70.4). No infections or compartment syndromes and 2 transient ulnar neuropraxias occurred. CONCLUSIONS: Closed reduction of type I OBBFFs was successful in 88.7% of cases. There were no infections after nonoperative management. Increases in cast index of 0.7 and postreduction radius translation on anteroposterior radiographs of 25% were associated with increased likelihood of failure, thus requiring surgery; age was not. LEVEL OF EVIDENCE: Level IV-retrospective comparative study.

Common and Consequential Fractures That Should Not Be Missed in Children.

Missed or delayed diagnosis of fractures in children is not uncommon owing to their immature skeletons, unique fracture patterns, and distinctive radiologic findings. The term occult is used to describe radiographically subtle fractures. Some of these fractures can be associated with excellent outcomes despite the pitfalls of delayed diagnosis. However, a subset of these injuries have more guarded prognoses when missed, despite their harmless radiographic appearance. A high index of suspicion should be maintained when treating pediatric extremity injuries with clinical findings disproportionate to a benign-appearing radiograph. Moreover, overreliance on radiology reports can perpetuate diagnostic error. In cases of discrepancy, timely follow-up for repeat examination or immediate advanced imaging can help avoid missed diagnoses. Most critically, the one diagnosis not to miss is nonaccidental trauma, as continued exposure to abuse puts the child at risk of further injury and death. [Pediatr Ann. 2022;51(9):e357-e363.].

Osteochondral Allograft Reconstruction of a Pediatric Distal Humerus Fracture with Articular Bone Loss: A Case Report.

CASE: A right hand dominant 10-year-old girl presenting with an open right distal humerus fracture dislocation involving complete medial column bone loss and a >50% trochlea defect was reconstructed with a size-matched, fresh distal humerus osteochondral allograft. Successful bony integration and functional elbow range of motion were achieved. CONCLUSION: A paucity of literature exists to guide the treatment of pediatric distal humerus fractures with significant bone loss. Despite complications associated with osteochondral allografts, they provide a reasonable treatment option to preserve elbow motion in children with unreconstructible intra-articular distal humerus fractures to avoid arthrodesis.

Quantification of Ankle Dorsiflexion in Ponseti-managed Unilateral Clubfoot Patients During Early Childhood.

BACKGROUND: Following the initial correction of a clubfoot using the Ponseti method, diminished passive ankle dorsiflexion may be observed over time, which could represent a possible relapsed deformity. Alternatively, the change may be attributable to patient age or other variables. Our purpose was to quantify passive ankle dorsiflexion in the involved and contralateral unaffected limbs of Ponseti-managed unilateral clubfoot patients, and to determine what patient-related variables influence this finding. METHODS: In total, 132 unilateral clubfoot patients were studied. Passive ankle dorsiflexion was measured in both limbs at each visit. Data were excluded from visits in which patients showed clear evidence of a relapse. Mean ankle dorsiflexion for clubfeet and contralateral unaffected limbs were reported for annual age intervals and compared using paired t tests. A general linear model was established to assess the effects of age, severity, sex, and side on ankle dorsiflexion. RESULTS: Mean ankle dorsiflexion for unaffected limbs declined with age, measuring 53±6 degrees between 0 and 1 year of age and decreasing to 39±7 degrees by 4 to 5 years of age. Similarly, mean ankle dorsiflexion in treated clubfeet declined with age, measuring 44±7 degrees between 0 and 1 year and 29±7 degrees between 4 and 5 years. Overall, the difference between limbs in these patients averaged ~10 degrees for every age interval through 9 years (P<0.001). Ankle dorsiflexion of clubfeet in 95% of patients aged 0 to 2 years was at least 20 degrees, and in 95% of patients aged 3 to 5 years this was at least 15 degrees. Patient age (P<0.001) and severity of deformity (P<0.001) were found to be the only significant factors affecting ankle dorsiflexion in the affected limbs. CONCLUSIONS: Ankle dorsiflexion in the Ponseti-treated clubfeet was influenced by age of the patient and the initial severity of the affected limb. Furthermore, our data suggest that, in patients who showed no relapse, a minimum of 20 degrees of ankle dorsiflexion in the corrected clubfoot is maintained through age 3 years and a minimum of 15 degrees is maintained through age 5 years. LEVEL OF EVIDENCE: Level IV-this is a retrospective case series.

Gender of presenters at orthopaedic meetings reflects gender diversity of society membership.

OBJECTIVE: To quantify the number of women presenters and their roles at national meetings across all orthopaedic sub-specialties. METHODS: A retrospective review of annual meeting programs for 2008 and 2017 from ten North American orthopaedic societies was conducted. RESULTS: A statistically significant increase was seen in the proportion of women presenting at society annual meetings between 2008 and 2017 (p < 0.0001). Women were more often authors presenting abstracts (p < 0.0001)) and less frequently faculty/instructors (p = 0.0051) and moderators/chairs (p = 0.0003) when compared to men. CONCLUSION: Men continue to hold a higher proportion of more respected roles within orthopaedic academia.

Risk of Knee Sepsis After Treatment of Open Tibia Fractures: A Multicenter Comparison of Suprapatellar and Infrapatellar Approaches.

OBJECTIVES: The suprapatellar approach for medullary nailing of the tibia is increasing. This requires intra-articular passage of instruments, which theoretically places the knee at risk of postoperative sepsis in the setting of open fracture. We hypothesized that the risk of knee sepsis is similar after suprapatellar or infrapatellar nailing of open tibia fractures. DESIGN: Retrospective, multicenter. SETTING: Three urban level 1 trauma centers. PATIENTS: All patients treated with medullary nailing for open diaphyseal tibia fractures (OTA 42) from 2009 to 2015. Patients younger than 18 years of age and with less than 12 weeks of follow-up were excluded. We identified 289 fractures in 282 patients. INTERVENTION: Suprapatellar (SP) or infrapatellar (IP) medullary nailing of open tibia fractures. MAIN OUTCOME MEASUREMENT: Occurrence of ipsilateral knee sepsis, defined as presence of a positive culture from knee aspiration or arthrotomy. Deep infection requiring operative debridement, superficial infection requiring antibiotic therapy alone, and all-cause reoperation were also recorded. RESULTS: IP nailing was used for 142 fractures. There were 20 infections (14.1%), of which 14 (9.8%) were deep. Fourteen tibias (9.8%) required reoperation for noninfectious reasons for 28 total reoperations (19.7%). SP nailing was used in 147 fractures. There were 24 infections (16.2%), of which 16 (10.8%) were deep. Fourteen additional tibias (9.5%) required reoperation for noninfectious reasons for a total of 30 reoperations (20.4%). There were no differences in the rates of infection, deep infection, or reoperation between groups. There were 2 cases of knee sepsis after SP nailing (1.4%) but zero cases after IP nailing (P = 0.5). CONCLUSIONS: There was no significant difference in the rate of knee sepsis with SP or IP approaches. The risk of knee sepsis after SP nailing of open fractures is low, but present. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Osteoconductive bone graft extenders in posterolateral thoracolumbar spinal fusion: a systematic review.

STUDY DESIGN: A systematic review. OBJECTIVE: To evaluate the efficacy, safety, and outcomes of osteoconductive bone graft extenders (BGEs) compared with iliac crest bone graft (ICBG) in posterolateral thoracolumbar spinal fusion. SUMMARY OF BACKGROUND DATA: ICBG is the current "gold standard" for achieving spinal arthrodesis. However, morbidity associated with its harvesting has led to the increased use of BGEs. METHODS: An electronic literature search was conducted through April 2011 using MEDLINE, EMBASE, CENTRAL, and Cochrane Library. Risk of bias and methodological assessment was performed using the Cochrane Risk of Bias Tool. Higgins I(2) test was used to assess for heterogeneity. Pooled weighted relative risk (RR) ratios were calculated to compare fusion and adverse event rates. Weighted standardized mean differences were calculated to compare functional outcome and pain scores. RESULTS: Thirteen studies were included representing a total of 768 patients. Overall study quality was low (mean Cochrane Risk of Bias score, 4.8 out of 12; range, 3-6). Fusion rates were comparable between the BGE and ICBG groups (RR, 0.96; 95% confidence interval [CI], 0.89-1.03; P = 0.28). Higgins I(2) test (58%) suggested substantial heterogeneity in the pooling of studies. The pooled rate of donor site pain in the ICBG group was 11.2% (95% CI, 7.4%-15.1%). Reported adverse events, excluding donor site pain, were significantly lower in the BGE group (RR, 0.42; 95% CI, 0.28-0.64; P < 0.0001). Functional outcomes were not significantly different between the 2 groups. CONCLUSION: Osteoconductive BGEs combined with local spine autograft and/or bone marrow aspirate have comparable fusion rates, similar functional outcomes, lower complication rates, and a lower risk of donor site pain than ICBG. Caution should be taken in interpreting these findings, given the low quality of the studies and the heterogeneity in the results. Randomized controlled studies using blinded assessments are required to help elucidate more conclusive evidence.