Implanted Pulse Generators in Lower Extremity Neuroprostheses: A 25-Year Review.

OBJECTIVES: Neuroprosthetic devices can improve quality of life by providing an alternative option for motor function lost after spinal cord injury, stroke, and other central nervous system disorders. The objective of this study is to analyze the outcomes of implanted pulse generators that our research group installed in volunteers with paralysis to assist with lower extremity function over a 25-year period, specifically, to determine survival rates and common modes of malfunction, reasons for removal or revision, and precipitating factors or external events that may have adversely influenced device performance. MATERIALS AND METHODS: Our implantable receiver-stimulator (IRS-8) and implantable stimulator-telemeter (IST-12 and IST-16) device histories were retrospectively reviewed through surgical notes, regulatory documentation, and manufacturing records from 1996 to 2021. RESULTS: Most of the 65 devices (64.6%) implanted in 43 volunteers remain implanted and operational. Seven underwent explantation owing to infection; seven had internal failures, and six were physically broken by external events. Of the 22 devices explanted, 15 were successfully replaced to restore recipients' enhanced functionality. There were no instances of sepsis or major health complications. The five infections that followed all 93 IRS and IST lower extremity research surgeries during this period indicate a pooled infection rate of 5.4%. The Kaplan-Meier analysis of technical malfunctions between the implant date and most recent follow-up shows five-, ten-, and 20-year device survival rates of 92%, 84%, and 71%, respectively. CONCLUSIONS: Incidence of malfunction is similar to, whereas infection rates are slightly higher than, other commonly implanted medical devices. Future investigations will focus on infection prevention, modifying techniques on the basis of recipient demographics, lifestyle factors, and education, and integrating similar experience of motor neuroprostheses used in other applications.

Utility of CT or X-ray in the management of adult nasal fracture.

PURPOSE: The primary objective of this study is to evaluate the use of imaging in the management of nasal fracture in adults and determine if imaging is beneficial to clinical decision making when planning for surgery. A secondary objective of this study is to compare surgical rates for nasal fracture between pediatric and adult populations. METHODS: This is a retrospective case-control study of 357 patients seen at University Hospitals Cleveland Medical Center from January 2015 through January 2020 with a diagnosis of nasal fracture. An odds ratio was calculated to determine likelihood of surgical intervention between patients who had imaging of the nasal bones and patients who did not. RESULTS: 82 % of patients had either CT or X-ray imaging. The odds ratio of patients who had surgery after CT or X-ray imaging compared to patients who had surgery without prior imaging was 0.092 (95 % CI: 0.0448-0.1898, p-value <0.0001). A total of 54 (15 %) adult patients had surgery, in comparison to 50 % of pediatric patients with diagnosis of nasal fracture. 202 (57 %) of patients did not follow up after initial diagnosis by radiology. CONCLUSION: The statistical analysis suggests that while CT and X-ray are frequently obtained in the setting of nasal fracture, patients without imaging are more likely to have surgery (p < 0.05) than patients with imaging. This indicates that imaging is likely unnecessary for surgical planning. Most adults do not pursue surgery, and surgical rates for adults with nasal fracture are much lower than those of pediatric patients with nasal fracture.

Efficacy of X-ray in the diagnosis of pediatric nasal fracture.

OBJECTIVE: Nasal fracture is one of the most common pediatric fractures, and diagnosis can be made with clinical findings or with radiographic imaging. The objective of this study is to determine the extent of x-ray utilization in decision-making regarding closed reduction of pediatric nasal fracture. METHODS: This a case-control study of 117 patients ages 0-18 with a diagnosis of nasal fracture seen at University Hospitals Cleveland Medical Center between January 2015 and January 2020. The exposure group had x-ray imaging of the nasal bones, and the control group had no x-ray imaging. RESULTS: A total of 59 (50.4%) patients had surgical intervention. The odds ratio to compare x-ray utilization to the control group for patients who underwent closed reduction surgery was .3951 (95% CI: 0.1848-0.8448, p-value = .0166). CONCLUSION: The statistical analysis suggests that x-ray use is associated with decreased rates of closed reduction surgery. It is likely that while not necessary for the diagnosis of nasal fracture, x-ray serves as an additional data point for diagnosis confirmation, and may reduce the rate of unnecessary surgery for false positive cases of nasal fracture.