Bone Flap Fixation Systems For Craniotomy Procedures

Not Applicable

Completed

• Conditions: Craniotomy
• Interventions: Device: Plates and screws; Device: Clamp-like system

• Registration Number: NCT04859907
• Lead Sponsor: NEOS Surgery

Brief Summary

Clinical investigation to compare the clinical safety and performance of a clamp-like device for craniotomy closure, with the standard of care system, titanium plates and screws.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-19
• Study First Submitted: 2021-04-15
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-26
• Primary Completion: 2022-11-19
• Status Verified: 2023-02
• Study Completion: 2023-02-16
• Last Update Submitted: 2023-07-28
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• The subject is 18 years or older.
• The subject can be implanted with the assigned craniotomy closure system according to its Instructions for Use.
• At least one post-operative medical image (CT scan or Magnetic Resonance image) is planned to be performed.
• Life expectancy higher than 6 months.
• The subject is willing to give his/her informed consent and to comply with the required follow-up.

Exclusion Criteria

• The subject presents any of the contraindications of the assigned craniotomy closure system.
• Orbitozygomatic or mastoid craniotomies.
• Posterior fossa (skull base) surgeries.
• Combined used of craniotomy systems (plates and clamps).
• The subject is currently participating in an investigational drug or device study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plates and screws	Plates and screws	-
Clamp-like system	Clamp-like system	-

Primary Outcome Measures

Name	Time	Method
Bone flap alignment score	6 months	1-4

Secondary Outcome Measures

Name	Time	Method
Post-craniotomy headache	6 months	Incidence
Device related artefacts in neuroimaging	6 months	frequency
Frequency of adverse effects and device deficiencies (device safety)	6 months	Frequency and type of Device related Adverse effects (AE and SAE) and device deficiencies
Surgeon usability questionnaire	0 days after surgery	Likert scale \[1-7\], where 1 is very difficult and 7 very easy
Device-related bulges or visible offsets	6 months	frequency
Bone-flap alignment score	0-7 days after surgery (before discharge)	1-4

Trial Locations

Locations (3)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Maribor University Medical Center; 🇸🇮 Maribor, Slovenia

Hospital Universitario la Paz; 🇪🇸 Madrid, Spain