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.

Sex-Based Differences in Adult ACL Reconstruction Outcomes.

PURPOSE OF REVIEW: In the setting of ever improving outcomes following anterior cruciate ligament (ACL) reconstruction, both objectively and subjectively, there remains continued interest in better understanding the differences in outcomes between male and female patients. The current review investigates the recent literature surrounding the roles of biological sex in adult ACL reconstruction outcomes. RECENT FINDINGS: Within the past five years, the most prominent and recurrent difference between male and female patient cohorts is the subjective report of pain and function. Female patients have been consistently shown to have worse self-reported outcomes following ACL reconstruction. Specific and quantifiable subjective outcomes that are highlighted include the International Knee Documentation Committee (IKDC) subjective score, the Knee injury and Osteoarthritis Outcome Score (KOOS), and patient-acceptable symptom state (PASS). Current research on the topic of biological sex-based differences in ACL reconstruction outcomes can be divided into four main categories: patient-reported subjective outcomes; physical assessment and gait analysis; kinematics; and rates of reinjury, revision, and contralateral reconstruction. This chapter provides a summary of recent literature focused on these four main areas of interest related to ACL reconstruction outcomes in males and females.

Effectiveness of Latarjet for anterior shoulder instability in patients with seizure disorder.

BACKGROUND: A paucity of literature exists on the outcomes after Latarjet for anterior shoulder instability in patients with seizure disorders (SDs). The purpose of this study was to determine the effectiveness of the Latarjet procedure for anterior shoulder instability in patients with SDs. METHODS: A retrospective review of patients undergoing Latarjet from 2013 to 2017 for anterior shoulder instability with minimum 2 years of clinical follow-up was performed. Patients were divided into two groups: patients diagnosed with SD, and patients without a history of seizure (control). Demographics, indications, SD details, and postoperative outcomes were collected. The incidence of complications, recurrent instability, revision surgery, and repeat seizure(s) were also examined. RESULTS: A total of 53 patients were identified, including 10 shoulders in 9 patients with an SD (88.9% male; mean age, 29.2 years [range, 20-37]), and 44 shoulders in 44 non-SD patients (86.4% male; mean age, 30.3 years [range, 18-52]). The mean follow-up time was 3.4 (range, 2.2-4.8) and 3.8 (range, 2.1-5.6) years in the SD and control group, respectively. During the follow-up period, 4 of 9 (44.4%) patients with an SD (50% shoulders) had a recurrent seizure postoperatively. Of those 4 patients, three sustained a recurrent dislocation of the operative shoulder(s) resulting from a postoperative seizure, including one who dislocated bilateral shoulders from a single seizure event after bilateral Latarjet procedures. There was no recurrent instability in patients who did not sustain a seizure in the postoperative period. Having a seizure in the postoperative period significantly increased the risk of recurrent dislocation (OR = 39.9, P = 0.04). CONCLUSIONS: Latarjet is a successful operation for recurrent anterior shoulder instability in patients without an SD. While it can still be successful in patients with SD, adequate control of seizures postoperatively is paramount to prevent recurrent instability episodes. Patients with an SD can be advised that if their seizures can remain controlled, they have a high likelihood of clinical success equal to that of patients without an SD.

Radius of Curvature in Patient-Specific Short Rod Constructs Versus Standard Pre-Bent Rods.

BACKGROUND: Recent studies support the need for sagittal alignment restoration when performing lumbar degenerative spinal fusions. The development of patient-specific spine rods (PSSRs) may help maintain or improve sagittal alignment in these surgeries. METHODS: A retrospective review was conducted for patients who underwent posterior spinal surgeries involving 4 or less levels. The preplanned PSSR radii of curvature (ROC) was compared with standard prebent rods with a ROC of 125 mm. All surgeries were performed at a single institution by 3 surgeons from September 2016 through October 2018. Data were then compared using a 2-tailed paired t test. PSSR had either 1 or 2 definitive ROCs. RESULTS: For rods with 2 ROCs, the "cranial" curve was measured between the upper instrumented level and L4 or L5. The "caudal" curve was measured between L4 or L5 and the lower instrumented level. The PSSR with 1 ROC and the caudal portion of the rods with 2 ROCs were significantly smaller than the industry standard ROC. CONCLUSIONS: PSSR demonstrate more acute ROC than industry standard rods. In PSRs, the most lordosis occurs between L4-S1 and flattens out at the thoracolumbar junction, mimicking the normal distribution of lumbar lordosis. PSSRs could help achieve or maintain sagittal alignment and prevent the sequela of flat back syndrome.