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

Phase 1

Completed

• Conditions: Skull Fixation After Craniotomy for Neurosurgical Procedures
• Interventions: Device: sutures; Device: Skull Grip bone fixation

• Registration Number: NCT00797979
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2008-11-24
• Study First Submitted QC: 2008-11-24
• Study First Posted: 2008-11-25
• Study Start: 2009-10
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-23
• Last Update Posted: 2012-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Major patient (aged ≥ 18 years)
2. Patient scheduled for craniotomy for a benign tumor
3. Patient informed and have signed informed consent

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Exclusion Criteria

1. Patient not affiliated with a social security scheme (or beneficiary entitled)
2. Patient with a known allergy to titanium
3. Patient non-compliant or whose follow-up to 3 months is impossible
4. Patient with against-indication scanner
5. Pregnant or lactating

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	sutures	Standard skull bon flap fixation, sutures
1	Skull Grip bone fixation	Skull Grip bone fixation

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of the "Skull Grip" new system of cranial flap fixation	2009

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Lariboisière, AP-HP, Neurochirurgie; 🇫🇷 Paris, Ile De France, France