The FDA Reclassification of Cervical Pedicle and Lateral Mass Screws: A Case Study in Regulatory History.

The classification of medical devices by the Food and Drug Administration (FDA) involves rigorous scrutiny from specialized panels that designate devices as Class I, II, or III depending on their levels of relative risk to patient health. Posterior rigid pedicle screw systems were first classified by the FDA in 1984 and have since revolutionized the treatment of many spine pathologies. Despite this early classification by the FDA, posterior cervical pedicle and lateral mass screws were not reclassified from unclassified to Class III and then to Class II until 2019, nearly 35 years after their initial classification. This reclassification process involved a decades-long interplay between the FDA, formal panels, manufacturers, academic leaders, practicing physicians, and patients. It was delayed by lawsuits and a paucity of data demonstrating the ability to improve outcomes for cervical spinal pathologies. The off-label use of thoracolumbar pedicle screw rigid fixation systems by early adopters assisted manufacturers and professional organizations in providing the necessary data for the reclassification process. This case study highlights the collaboration between physicians and professional organizations in facilitating FDA reclassification and underscores changes to the current classification process that could avoid the prolonged dichotomy between common medical practice and FDA guidelines.

Neurovascular Compression in Patients With Trigeminal Neuralgia May Be Associated With Worse Outcomes After Primary Percutaneous Rhizotomy.

BACKGROUND AND OBJECTIVES: Percutaneous rhizotomy may be an effective primary intervention in patients with trigeminal neuralgia who are poor candidates for microvascular decompression or those who desire a less invasive approach. However, the influence of neurovascular compression on pain-free survival after primary percutaneous rhizotomy is not well understood. METHODS: We retrospectively reviewed all patients undergoing percutaneous rhizotomy at our institution from 1995 to 2022. Patients were included if they had no history of surgical intervention, available preoperative MRI imaging, and postoperative follow-up data. Barrow Neurological Institute pain scores were assigned at various time points. We collected baseline patient information, pain characteristics, and perioperative complications for each patient. In addition, we recorded evidence of pain recurrence. Patients were dichotomized into those with evidence of neurovascular compression on preoperative MRI vs those without. The effect of neurovascular compression on pain-free survival was assessed using Kaplan-Meier Cox proportional hazards analyses. RESULTS: Of the 2726 patients reviewed, 298 met our inclusion criteria. Our study comprised 261 patients with no evidence of neurovascular compression on preoperative MRI vs 37 patients with evidence of neurovascular compression on preoperative MRI. Patients in the compression group had a shorter median duration to recurrence compared with those in the no compression group, P = .01. Kaplan-Meier survival analysis revealed that patients with preoperative evidence of neurovascular compression on MRI imaging demonstrated shorter pain-free survival compared with those without such evidence [hazard ratio = 1.57 (1.03-2.4), P = .037]. Cox proportional hazards analysis demonstrated that evidence of neurovascular compression was associated with poor pain-free survival [hazard ratio = 1.64 (1.06-2.53), P = .03]. CONCLUSION: Patients with neurovascular compression on preoperative MRI may experience reduced time to recurrence compared with those without after percutaneous rhizotomy. These patients should be counseled on potential reduced efficacy of percutaneous rhizotomy as a primary intervention for their pain.

An assessment of the variation in the practice of lumbar discectomy and its role in axial back pain.

Background: Lumbar discectomy is performed for symptomatic lumbar disc herniation and is one of the most widely performed spinal surgical procedures worldwide in a variety of ways. This survey aimed at providing an overview/perspective of different practice patterns and the impact of lumbar discectomy on axial back pain with or without sciatica. Methods: An online survey was performed using the application "Google Forms." The link to the questionnaire was distributed to neurosurgeons through personal E-mail and social media platforms. Results: We received 333 responses. The largest percentage of responses across five continents was from Asia (66.97%, n = 223). The mean age of the respondents was 40.08 ± 10.5 years. A total of 66 respondents (20%) had a spine practice of 7%-90%, and 28 respondents had a spine practice of 90%-100% (8.4%). The number of respondents who practiced microscopic discectomy using a tubular retractor (n = 143 respondents, 42.9%) was nearly equal to the number of respondents who practiced open discectomy (n = 142 respondents, 42.6%). An almost equal proportion of respondents believed discectomy does not help in relieving axial back pain. Only 20.4% (n = 68) of respondents recommend bed rest for a longer duration postoperatively. Conclusions: Our survey revealed that only 22.2% of spine surgeons recommended discectomy in patients with radiological disc herniation with axial back pain alone and preferred a minimally invasive method of discectomy. Almost half of them believed discectomy to be ineffective for axial low back pain and only a few recommended prolonged bed rest postoperatively.

The ASGLOS Study: A global survey on how predatory journals affect scientific practice.

Predatory journals and conferences are an emerging problem in scientific literature as they have financial motives, without guaranteeing scientific quality and exposure. The main objective of the ASGLOS project is to investigate the predatory e-email characteristics, management, and possible consequences and to analyse the extent of the current problem at each academic level. To collect the personal experiences of physicians' mailboxes on predatory publishing, a Google Form® survey was designed and disseminated from September 2021 to April 2022. A total of 978 responses were analysed from 58 countries around the world. A total of 64.8% of participants indicated the need for 3 or fewer emails to acquire a criticality view in distinguishing a real invitation from a spam, while 11.5% still have doubt regardless of how many emails they get. The AGLOS Study clearly highlights the problem of academic e-mail spam by predatory journals and conferences. Our findings signify the importance of providing academic career-oriented advice and organising training sessions to increase awareness of predatory publishing for those conducting scientific research.

A racial analysis of pain outcomes following microvascular decompression for trigeminal neuralgia.

OBJECTIVE: Pain outcomes by race in trigeminal neuralgia (TN) are not well investigated. The authors aimed to compare microvascular decompression (MVD) outcomes in TN patients on the basis of self-identified race. METHODS: The authors retrospectively reviewed all patients with TN who underwent MVD at their institution from 2007 to 2020. Each patient's self-reported race was recorded, and Barrow Neurological Institute (BNI) scores for pain and numbness were compared. Factors associated with pain recurrence were assessed using survival analyses and multivariate regressions. RESULTS: Of 1011 patients, 925 reported their racial demographic characteristics, and patients who identified as Native American or American Indian and Native Hawaiian or Pacific Islander were excluded due to small sample sizes. Of the resulting 921 patients, 697 (75.7%) patients identified as White, 108 (11.7%) as Black or African American, 39 (4.2%) as Asian, and 77 (8.4%) as other. Compared with White patients, Black TN patients were more likely to present with type 1 TN (p = 0.02). At final follow-up, the mean BNI pain score of Black patients was significantly higher (p < 0.001) compared with that of White patients, although pain scores did not differ preoperatively. The adjusted multivariate ordinal regression model showed that Black patients were associated with higher BNI pain scores at final follow-up (p = 0.01). Furthermore, compared with White patients, Black patients were at increased risk for postoperative pain recurrence (p = 0.04), which additionally occurred after a shorter median pain-free duration (p = 0.03). CONCLUSIONS: TN patients who identify as Black or African American exhibit worse postoperative pain outcomes after MVD compared with White patients. Future studies investigating the factors driving these racial differences are warranted.