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BACKGROUND: Trauma to the thoracic, thoracolumbar (TL), and lumbar spine is common and can cause disability and neurological deficits. Using a cohort of patients suffering from thoracic, TL, and lumbar spine trauma in a tertiary hospital in East Africa, the current study sought to: (1) describe demographics and operative treatment patterns, (2) assess neurologic outcomes, and (3) report predictors associated with undergoing surgery, neurologic improvement, and mortality. METHODS: A retrospective cohort study of patient records from September 2016 to December 2020 was conducted at a prominent East Africa referral center. The study collected data on demographics, injury, and operative characteristics. Surgical indications were assessed using the AO (Arbeitsgemeinschaft für Osteosynthesefragen) TL fracture classification system and neurological function. Logistic regression analysis identified predictors for operative treatment, neurologic improvement, and mortality. RESULTS: The study showed that 64.9% of the 257 TL spine trauma patients underwent surgery with a median postadmission day of 17.0. The mortality rate was 1.2%. Road traffic accidents caused 43.6% of the injuries. The most common fracture pattern was AO Type A fractures (78.6%). Laminectomy and posterolateral fusion were performed in 97.6% of the surgical cases. Patients without neurological deficits (OR: 0.27, 95% CI: 0.13-0.54, P < 0.001) and those with longer delays from injury to admission were less likely to have surgery (OR: 0.95, 95% CI: 0.92-0.99, P = 0.007). The neurologic improvement rate was 11.1%. Univariate analysis showed a significant association between surgery and neurologic improvement (OR: 3.83, 95% CI: 1.27-16.61, P < 0.001). However, this finding was lost in multivariate regression. CONCLUSIONS: This study highlights various themes surrounding the management of TL spine trauma in a low-resource environment, including lower surgery rates, delays from admission to surgery, safe surgery with low mortality, and the potential for surgery to lead to neurologic improvement. CLINICAL RELEVANCE: Despite challenges such as surgical delays and limited resources in East Africa, there is potential for surgical intervention to improve neurologic outcomes in thoracic, TL, and lumbar spine trauma patients.
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INTRODUCTION: Spinal implants play a vital role in healthcare delivery, and regulations are necessary to ensure their quality, approval, access, and use. In this article, we examine the current state of regulation and approval procedures for medical devices in low- and middle-income countries (LMICs), emphasizing the situation in Tanzania. AREAS COVERED: We conducted a systematic literature search and interviewed a local spine implant representative to investigate the approval, availability, and access of surgical and spinal implants in LMICs, particularly in Africa. Out of the 18 included articles, six referred to African regulations, with no mention of spinal implants. Our analysis revealed that LMICs face challenges in accessing implants due to affordability, poor supply chain, and lack of expertise for their application. However, surgeons have found alternative solutions, such as using lower-cost implants from Turkish manufacturers. The Tanzania Medical Devices and Drugs Authority oversees the local regulatory and approval process for implants. EXPERT OPINION: Regulation and accessibility of spinal implants in LMICs, particularly in Africa, are limited and negatively impact patient care and best medical practice. Potential solutions include capacity building within and collaboration among regulatory organizations to improve regulatory processes and allocating financial resources to qualitative and quantitative implant access.
