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

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.

Study Overview

• Status: Completed
• Conditions: Skull Fixation After Craniotomy for Neurosurgical Procedures
• Intervention / Treatment: Device: Skull Grip bone fixation; Device: sutures

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75010
      • CHU Lariboisière, AP-HP, Neurochirurgie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Skull Grip bone fixation	Device: Skull Grip bone fixation; Skull Grip bone fixation
Active Comparator: 2; Standard skull bon flap fixation, sutures	Device: sutures; Standard skull bon flap fixation, sutures; Other Names: Standard skull bon flap fixation, sutures

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Salvatore CHIBBARO, MD, Hôpital Lariboisière, Neurochirurgie

Publications and helpful links

General Publications

• Chibbaro S, Makiese O, Bresson D, Hamdi S, Cornelius JF, Guichard JP, Reiss A, Bouazza S, Vicaut E, Ricci A, Galzio R, Poczos P, George B, Marsella M, Di Emidio P. Skull bone flap fixation - reliability and efficacy of a new grip-like titanium device (Skull Grip) versus traditional sutures: a clinical randomized trial. Minim Invasive Neurosurg. 2011 Oct;54(5-6):282-5. doi: 10.1055/s-0031-1297246. Epub 2012 Jan 25.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: November 24, 2008
• First Submitted That Met QC Criteria: November 24, 2008
• First Posted (Estimate): November 25, 2008

Study Record Updates

• Last Update Posted (Estimate): November 27, 2012
• Last Update Submitted That Met QC Criteria: November 23, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Craniotomy; Skull fixation; Skull Grip; Reconstructive cranial surgery
• Other Study ID Numbers: P080501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No