Assessment of the performance of Lyoplant(R) Onlay for duraplasty. An observational, multi-center Post Market Clinical Follow-up study.

ObjectiveDuraplasty with a dura mater substitute can become necessary after cranial or spinal surgery. Several dura grafts from different materials are available. The goal of this study was to assess the clinical performance of a suturable onlay dura substitute composed of bovine collagen. MethodsA prospective, observational, multicenter, single-arm clinical study with the dura substitute Lyoplant(R) Onlay was performed. Different performance parameters for safety and performance were assessed. Additionally, postoperative MRI / CT images were evaluated. ResultsData of 61 patients recruited by three study centers were included. Lyoplant(R) Onlay was used by a variety of surgeons with different levels of experience. Cranial and spinal cases with a wide range of dura defect sizes were included. No reoperation due to a cerebrospinal fluid leakage occurred until discharge (primary endpoint), as well as to the follow-up (about four months postoperatively). The incidence rate of cerebrospinal fluid leakages was 6.6%. All of these adverse events were reported as non-serious complications without the need of a surgical intervention and were resolved without sequelae. The handling properties of Lyoplant(R) Onlay were positively rated. In external radiologic analysis of postoperative MRI / CT images at discharge and follow-up, additional fluid collection, edema, and swelling were observed. However, they were clinically inapparent and considered normal postsurgical findings. ConclusionsThe incidence rate of cerebrospinal fluid leakages was 6.6% and ranged in the values reported in the literature. These results show that Lyoplant(R) Onlay is a safe and efficient dura substitute. HighlightsO_LILyoplant(R) Onlay is a safe and effective bovine dura substitute C_LIO_LIUniversal product for onlay or suturable application, cranial and spinal surgeries C_LIO_LINo re-operations because of CSF leakage C_LIO_LIVery good handling characteristics C_LIO_LIProspective study with 61 patients, 3 study centers and 4 months follow-up C_LI