Assessment of the Performance of LYoplant® ONlay for Duraplasty

Completed

• Conditions: Spinal Surgery; Duraplasty; Craniotomy
• Interventions: Device: Lyoplant Onlay

• Registration Number: NCT02678156
• Lead Sponsor: Aesculap AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-05
• Study First Posted: 2016-02-09
• Study Start: 2016-04
• Primary Completion: 2017-10
• Study Completion: 2018-02-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LYoplant ONlay	Lyoplant Onlay	Primary objective of the study is the generation of clinical data in patients receiving Lyoplant® Onlay for dura repair to assess its safety.

Primary Outcome Measures

Name	Time	Method
Incidence of re-operation because of Cerebrospinal Fluid leakage	until discharge (approximately 1 week)

Secondary Outcome Measures

Name	Time	Method
Incidence of re-operation because of Cerebrospinal Fluid leakage	until follow-up (4 ± 2 months)
Incidence of post operative complications	until discharge (approximately 1 week, 4±2 months)	Cerebrospinal Fluid leakage, pseudomeningocele, fistulae, infection, meningitis and others
Incidence of cerebral reactions edema, soft tissue swelling, Cerebrospinal Fluid leakage	until discharge (approximately 1 week, 4±2 months)	detected during routine post operative MRI / CT examinations
Intraoperative handling of the device	Intraoperative	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

Trial Locations

Locations (3)

Klinikum Darmstadt; 🇩🇪 Darmstadt, Germany

Klinik für Neurochirurgie; 🇩🇪 Homburg/Saar, Germany

Klinikum Idar-Oberstein; 🇩🇪 Idar-Oberstein, Germany