Assessment of the Performance of LYoplant® ONlay for Duraplasty

Study Overview
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Brief Summary
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The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the performance of Lyoplant® Onlay. To assess the performance of the product, various safety and efficacy parameters have been selected.

Official Title
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Assessment of the Performance of LYoplant® ONlay for Duraplasty. A Non-interventional, Multi-centre Post Market Clinical Follow-up (PMCF) Study.

Conditions
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Craniotomy, Duraplasty, Spinal Surgery

Intervention / Treatment
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* Device: Lyoplant Onlay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing an elective cranial or spinal surgery, probably with the need of a duraplasty using Lyoplant® Onlay Written informed consent Life expectancy > 6 months Age > 18 years Exclusion Criteria: Active local or systemic infections Open cranial trauma Open spina bifida Known hypersensitivity to proteins of bovine origin Representation by a legal guardian or under involuntary commitment Pregnancy Participation in another clinical study Known primary immunodeficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LYoplant ONlay<br>Primary objective of the study is the generation of clinical data in patients receiving Lyoplant® Onlay for dura repair to assess its safety. | Device: Lyoplant Onlay<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of re-operation because of Cerebrospinal Fluid leakage |  | until discharge (approximately 1 week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of re-operation because of Cerebrospinal Fluid leakage |  | until follow-up (4 ± 2 months) | 
| Incidence of post operative complications | Cerebrospinal Fluid leakage, pseudomeningocele, fistulae, infection, meningitis and others | until discharge (approximately 1 week, 4±2 months) | 
| Incidence of cerebral reactions edema, soft tissue swelling, Cerebrospinal Fluid leakage | detected during routine post operative MRI / CT examinations | until discharge (approximately 1 week, 4±2 months) | 
| Intraoperative handling of the device | Intraoperative handling of the device using a questionnaire containing different dimension and a 5 point (1 = excellent, 5 = unacceptable) assessment level (Likert Scale). The following dimensions are assessed: Ease of cutting Needle penetration Adaptation to the tissue Suture retention strength Onlay effect Quality of sealing Thickness Tensile strength Overall satisfaction | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dura mater substitute, Graft, Lyoplant, Lyostypt, Lyoplant onlay, Xenograft