Clinical trial NCT00797979: Implant System for Fixation of Cranial Bone Flaps After Craniotomy for Brain Surgery
Official title: Implant System for Fixation of Cranial Bone Flaps After Craniotomy for Brain Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skull Fixation After Craniotomy for Neurosurgical Procedures
Keywords: Craniotomy
Skull fixation
Skull Grip
Reconstructive cranial surgery
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the efficacy of the "Skull Grip" new system of cranial flap fixation
timeFrame: 2009
Secondary outcomes:
measure: To evaluate the security of "Skull Grip" new system of cranial flap fixation
timeFrame: 2009
measure: Compare functional benefits (ease and speed of implementation) of "Skull Grip" new system of cranial flap fixation compared with traditional sutures
timeFrame: 2009
Other outcomes:
Locations:
city: Paris
country: France
facility: CHU Lariboisière, AP-HP, Neurochirurgie
state: Ile De France
Study officials:
affiliation: Hôpital Lariboisière, Neurochirurgie
name: Salvatore CHIBBARO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.