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.

The Frequency and Outcomes of Nerve Palsies in Operatively Treated Supracondylar Humerus Fractures.

BACKGROUND: A high index of suspicion for nerve palsy is essential in the setting of a displaced supracondylar humerus fracture (SCHF) with careful attention to the examination. We hypothesize that nerve injuries are more prevalent in higher energy type III and flexion SCHFs compared with type II fractures. METHODS: A retrospective review was performed of 1085 operatively treated SCHFs in pediatric patients, aged 0 to 14 years, between January 1, 2015 and December 31, 2018. There were 979 patients eligible for analysis. Exclusion criteria included follow-up <3 weeks, polytrauma, pathologic fracture, and prior fracture of the ipsilateral elbow. RESULTS: The overall rate of nerve injury was 10.6% (104/979). A significant difference in the rate of nerve palsy was identified between fracture types: 0.9% type II, 19.3% type III, and 10.7% flexion type SCHFs ( P <0.001). Median nerve palsy was the most common (n=65). An increased rate of ulnar nerve palsy was observed in flexion type SCHFs. The rate of nerve palsy was higher in the medial pin group (14.9%, P =0.035) but no significant association with iatrogenic ulnar nerve palsy was present. In type III and flexion SCHFs, operative time >60 minutes ( P =0.023) and the need for open reduction ( P =0.012) were significantly associated with postoperative nerve palsy. Referral to therapy was required in 30.8% of patients with a nerve palsy compared with 7.9% of patients without ( P <0.001). CONCLUSION: Longer operative times, need for open reduction, and significantly higher rates of nerve palsy among type III and flexion SCHFs are best explained by the unstable nature of the fracture and greater degree of soft tissue trauma. Given prolonged duration of follow-up and more frequent need for therapy demonstrated in patients with a nerve palsy, these data can be used to improve counseling for families and patients after displaced SCHF. LEVEL OF EVIDENCE: Level III-retrospective comparative study.

Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017.

Importance: The US Food and Drug Administration (FDA) uses 510(k) clearance and premarket approval (PMA) pathways to ensure device safety before marketing. Premarket approval evaluates high-risk medical devices and requires clinical trials, whereas 510(k) clearance evaluates moderate-risk devices and relies on benchtop (nonclinical and biomechanical) and descriptive data. Existing literature suggests that the clinical trials required by PMA are associated with reduced risk of recall compared with devices granted 510(k) clearance. Several investigators have found weaknesses in pivotal PMA trials, raising safety concerns. Furthermore, methodological factors may have led to a previous underestimation of recall risk for devices with PMA. Objectives: To compare risk of recall and high-risk recall between devices that received 510(k) clearance and those that received PMA and to compare the risk of recall between devices for medical specialties. Design, Setting, and Participants: This cohort study compared devices with 510(k) clearance vs those with PMA that reached the market between January 1, 2008, and December 31, 2017. Two- to 12-year follow-up was obtained from the FDA's 510(k) and PMA medical device database. Orthopedic surgery was chosen arbitrarily as the reference category for analysis between specialties because no baseline exists. Statistical analysis was performed from February 1 to November 1, 2020. Main Outcomes and Measures: The FDA issues recalls for safety concerns. These recalls are stratified into class I, II, and III, with class I representing high-risk issues for serious harm or death. The main outcome was the hazard ratio of any recall and class I recall between devices with PMA and those with 510(k) clearance. The secondary outcome was the recall hazard ratio between specialties with respect to the reference category. A single Cox proportional hazards regression model evaluating the association of medical specialty and FDA approval pathway with the risk of recall was performed. Results: During the study period, 28 246 devices received 510(k) clearance and 310 devices (10.7%) received PMA; 3012 devices (10.7%) with 510(k) clearance and 84 devices (27.1%) with PMA were recalled. A total of 216 devices (0.8%) with 510(k) clearance and 16 devices (5.2%) with PMA had class I recalls. Devices with PMA compared with those with 510(k) clearance had a hazard ratio for recall of 2.74 (95% CI, 2.19-3.44; P < .001) and a hazard ratio for high-risk recall of 7.30 (95% CI, 4.39-12.13; P < .001). Only radiologic devices were associated with an increased risk of recall (hazard ratio, 1.57; 95% CI, 1.32-1.87; P < .001), whereas 6 specialties were assocated with a decreased risk compared with the orthopedic reference category: general and plastic surgery, otolaryngology, obstetrics and gynecology, physical medicine, hematology, and general hospital. Conclusions and Relevance: This study suggests that high-risk medical devices approved via PMA are associated with a greater risk of recall than previously reported. Most recalls are for devices with 510(k) clearance, also raising safety concerns. Strengthening postmarketing surveillance strategies and pivotal trials may improve device safety.

The Risk of Assuming Abuse in an Infant with an Isolated Metaphyseal Lesion: A Case Report.

CASE: The classic metaphyseal lesion, or corner fracture, is considered a strong indicator of nonaccidental trauma. In the present case, the parents brought their 8-month-old boy to a community hospital after he stopped crawling on the right leg. A knee radiograph demonstrated an isolated metaphyseal lesion, which prompted concern for child abuse. The patient was transferred to the nearest academic medical center; the pediatric radiology expert in child abuse determined that the lesion was a normal variant and not the result of abuse. CONCLUSION: An isolated metaphyseal lesion is not pathognomonic for child abuse, and a thoughtful differential diagnosis should be considered.

New Paradigms in Post-Graduate Surgical Education.

With a growing focus on patient safety and trainee education, the Accreditation Council for Graduate Medical Education implemented changes including work hour restrictions, focused clinical competencies, and the Next Accreditation System (NAS). The NAS poses initial challenges on residencies with the implementation of surgical simulation programs and defining resident competency. It is the hope that innovative training methods will allow for improved advancement of knowledge and surgical skills given the current direction of post-graduate surgical training.

Novel ring chemistry of vitamin B6 with singlet oxygen and an activated ene: isolated products and identified intermediates suggesting an operable [3 + 2] cycloaddition.

Pyridoxine reaction with (1)O(2) in aqueous solution at neutral pH resulted in oxidation at the 2- and 6-positions of the pyridine ring and unprecedented ring contraction. Kinetic and low temperature studies provided observable intermediates by NMR spectroscopy. In addition, novel cycloaddition between pyridoxine and N-methylmaleimide, without N-alkylation and in water, suggest a common [3 + 2] cycloaddition with the 3-hydroxypyridine ring.