AI Article Synopsis

  • The INSPIRE study assessed the safety and neurological recovery of a bioresorbable polymer device called the Neuro-Spinal Scaffold (NSS) in patients with complete thoracic spinal cord injuries over a period of 24 months following implantation.
  • Out of 19 patients who received the NSS, 44% showed significant neurological improvement within 6 months, with some patients continuing to improve even after a year.
  • The findings indicate that NSS implantation is safe, with no serious adverse effects noted, and support the continued potential benefits of this treatment for spinal cord injury patients.

Article Abstract

Background: Based on 6-month data from the InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurological Recovery in Patients with Complete Thoracic Spinal Cord Injury (INSPIRE) study (NCT02138110), acute implantation of an investigational bioresorbable polymer device (Neuro-Spinal Scaffold [NSS]) appeared to be safe in patients with complete thoracic spinal cord injury (SCI) and was associated with an ASIA Impairment Scale (AIS) conversion rate that exceeded historical controls.

Objective: To evaluate outcomes through 24 months postimplantation.

Methods: INSPIRE was a prospective, open-label, multicenter, single-arm study. Eligible patients had traumatic nonpenetrating SCI with a visible contusion on MRI, AIS A classification, neurological level of injury at T2-T12, and requirement for open spine surgery ≤96 hours postinjury.

Results: Nineteen patients underwent NSS implantation. Three patients had early death determined by investigators to be unrelated to the NSS or its implantation procedure. Seven of 16 evaluable patients (44%) had improvement of ≥1 AIS grade at 6 months (primary end point) to AIS B (n = 5) or AIS C (n = 2). Three patients with AIS B at 6 months had further neurological improvement to AIS C by 12 (n = 2) and 24 (n = 1) months, respectively; none have deteriorated per latest available follow-up. No unanticipated or serious adverse device effects were reported.

Conclusion: In this small group of patients with complete thoracic SCI, acute NSS implantation within the spinal cord appeared to be safe with no long-term neurological issues identified during the 24-month follow-up. Patients remain stable, with additional AIS conversions observed in some patients at 12 months and beyond. These data further support the safety and probable benefit of NSS implantation in this patient population.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9067089PMC
http://dx.doi.org/10.1227/neu.0000000000001932DOI Listing

Publication Analysis

Top Keywords

patients complete
16
complete thoracic
16
spinal cord
16
nss implantation
16
thoracic spinal
12
cord injury
12
patients
11
acute implantation
8
bioresorbable polymer
8
24-month follow-up
8

Similar Publications

Lower socioeconomic status is correlated with worse outcomes after arthroscopic rotator cuff repair.

J Orthop Surg Res

December 2024

Department of Orthopaedic Surgery, Henry Ford Hospital, Henry Ford Health, 2799 W. Grand Blvd CFP-6, Detroit, MI, 48202, USA.

Background: Socioeconomic status has been recognized as a crucial social determinant of health influencing patient outcomes. Area Deprivation Index (ADI) is a validated measure of an area's socioeconomic status. Limited data exists on the impact of ADI and clinical outcomes and complications following rotator cuff repair (RCR).

View Article and Find Full Text PDF

Background: Loss to follow-up (LTFU) of patients with presumed tuberculosis (TB) before completing the diagnostic process (pre-diagnosis LTFU) and before initiating treatment for those diagnosed (pre-treatment LTFU) is a challenge in the realization of the End TB Strategy. We assessed the proportion of pre-diagnosis and pre-treatment LTFU and associated factors among patients with presumed TB and those diagnosed in the selected health facilities.

Methods: This was a retrospective cohort study involving a review of routinely collected data from presumptive, laboratory and TB treatment registers from January 2019 to December 2022.

View Article and Find Full Text PDF

Background: Ultrasonography (USG), which is used as the first step in the diagnosis of acute appendicitis (AA), sometimes cannot visualize the appendix. The aim of this study was to retrospectively analyze the clinical, imaging, and pathology results of these cases and to provide information to clinicians about the next step to be taken.

Methods: The study was performed retrospectively between January 1, 2021 and December 31, 2021.

View Article and Find Full Text PDF

[Modified endoscopic mucosal resection for the treatment of early gastrointestinal lesions].

Zhonghua Wei Chang Wai Ke Za Zhi

December 2024

Department of Gastroenterology, Dongguan Children's Hospital Affiliated to Guangdong Medical University, Dongguan Eighth People's Hospital, Dongguan523000, China.

To evaluate the clinical efficacy of modified endoscopic mucosal resection (EMR) in the management of early gastrointestinal lesions. Upon endoscopic identification of the lesion, normal saline is injected into the submucosa to establish a fluid cushion, which elevates the lesion's mucosa. Methylene blue may also be applied to improve visualization of the relationship between the submucosa and muscular layer.

View Article and Find Full Text PDF

Comparative analysis between genotypes of adenovirus isolates from hospitalized children with acute respiratory tract infections and clinical manifestations in Wuhan, China, from June 2022 to September 2023.

Virol Sin

December 2024

Department of Laboratory Medicine, Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430070, China; School of Laboratory Medicine, Hubei University of Chinese Medicine, Wuhan 430065, China. Electronic address:

Acute respiratory tract infections (ARTIs) are among the leading causes of morbidity and mortality in children worldwide. Human adenovirus (HAdV) infections are estimated to account for at least 5% of pediatric ARTIs. The circulated genotypes of HAdV and the correlation between genotype and clinical manifestations in Wuhan, China, before and after the complete relaxation of nonpharmaceutical interventions against severe acute respiratory syndrome coronavirus 2, remain unknown.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!