Implant System for Fixation of Cranial Bone Flaps After Craniotomy for Brain Surgery

Study Overview
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Brief Summary
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Bone flaps after craniotomy are typically fixed with suture material, mini plates and others devices. In some cases, fixation with suture material is not secure as it may result in shifting of the bone flap with its dislocation. We will test the safety and efficacy of SKULL GRIP a new device for fixation of the bone flap during cranial procedure comparing to traditional suture materials.

Detailed Description
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At the end of the operation to start the fixation of cranial bone flaps, at least three Skull Grip titanium clamps will be positioned equidistant to one another along the craniotomy opening. The lower parts (complete circle) will be inserted between the dura and the cranium. The linear parts of the superior semicircle have to be in line with the craniotomy borders to allow the lodging of the bone flap. The different heights of the device are finalized to suit it for the different thickness of the cranial vault. The same procedure will be performed with all remaining Skull Grip titanium clamps.The bone flap will be then placed in its original position. By using a forceps, a simple and easy clockwise rotation of the superior semicircle will allow to block the SKULL GRIP clamp in place. For simple removal if necessary of the Skull Grip titanium clamps, even if bone ossification of the craniotomy edges has already occurred, it will be necessary just to lift up the superior semicircle of the Skull Grip by a forceps and to cut by a cutting forceps the pin between the two circle. Then, craniotomy could be completed in a standard way.

Official Title
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Implant System for Fixation of Cranial Bone Flaps After Craniotomy for Brain Surgery

Conditions
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Skull Fixation After Craniotomy for Neurosurgical Procedures

Intervention / Treatment
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* Device: Skull Grip bone fixation
* Device: sutures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major patient (aged ≥ 18 years) Patient scheduled for craniotomy for a benign tumor Patient informed and have signed informed consent Exclusion Criteria: Patient not affiliated with a social security scheme (or beneficiary entitled) Patient with a known allergy to titanium Patient non-compliant or whose follow-up to 3 months is impossible Patient with against-indication scanner Pregnant or lactating

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Skull Grip bone fixation | Device: Skull Grip bone fixation<br>* Skull Grip bone fixation<br>|
| Active Comparator: 2<br>Standard skull bon flap fixation, sutures | Device: sutures<br>* Standard skull bon flap fixation, sutures<br>* Other names: Standard skull bon flap fixation, sutures;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of the Skull Grip new system of cranial flap fixation |  | 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the security of Skull Grip new system of cranial flap fixation |  | 2009 | 
| Compare functional benefits (ease and speed of implementation) of Skull Grip new system of cranial flap fixation compared with traditional sutures |  | 2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Craniotomy, Skull fixation, Skull Grip, Reconstructive cranial surgery