ReviewSurgical neurology international2021
Medicolegal corner (spine): Contraindicated use of DuraSeal in anterior cervical spine led to quadriplegia.
Review in Surgical neurology international, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
4 citing papers in PubMed, 8 citations in OpenAlex.
- A low-swelling hydrogel as a multirole sealant for efficient dural defect sealing and prevention of postoperative adhesion.National science review · 2024Article
- A tough bioadhesive hydrogel supports sutureless sealing of the dural membrane in porcine and ex vivo human tissue.Science translational medicine · 2024Article
- Review/Perspective: Incidence and treatment of CSF leaks/dural tears (DT) occurring during anterior cervical surgery.Surgical neurology international · 2024Review
- Article
Corrections and comments
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Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe package insert for DuraSeal (Integra LifeSciences, Princeton NJ) states it is
methodsA spinal surgeon interpreted a geriatric patient's MR as showing severe C3-C4 to C5-C6 anterior cord compression due to disc disease/spondylosis. However, he never reviewed the CT report/images that documented marked ossification of the posterior longitudinal ligament (OPLL) with multiple signs of dural penetrance.
resultsThe anterior C4, C5 corpectomy, and C3-C6 strut fusion/plating resulted in a massive, irreparable cerebrospinal fluid (CSF) leak. Despite the contraindications, the surgeon mistakenly applied DuraSeal which caused the patient's postoperative quadriplegia (i.e., as documented on the delayed postoperative MR scan). Following a secondary surgery consisting of a laminectomy/posterior fusion, the patient was still quadriplegic. Further, as he requested no postoperative MR scan and performed no subsequent corrective surgery (i.e., anterior removal of DuraSeal), the patient remained permanently quadriplegic.
conclusionDuraSeal is directly contraindicated for use in the anterior cervical spine, with/without a CSF leak. Here, utilizing DuraSeal for anterior cervical OPLL surgery resulted in permanent quadriplegia, and was below the standard of care.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.