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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00797979
First received: November 24, 2008
Last updated: November 23, 2012
Last verified: November 2012

November 24, 2008
November 23, 2012
October 2009
July 2010   (final data collection date for primary outcome measure)
To evaluate the efficacy of the "Skull Grip" new system of cranial flap fixation [ Time Frame: 2009 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00797979 on ClinicalTrials.gov Archive Site
  • To evaluate the security of "Skull Grip" new system of cranial flap fixation [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]
  • Compare functional benefits (ease and speed of implementation) of "Skull Grip" new system of cranial flap fixation compared with traditional sutures [ Time Frame: 2009 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Implant System for Fixation of Cranial Bone Flaps After Craniotomy for Brain Surgery
Implant System for Fixation of Cranial Bone Flaps After Craniotomy for Brain Surgery

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Skull Fixation After Craniotomy for Neurosurgical Procedures
  • Device: Skull Grip bone fixation
    Skull Grip bone fixation
    Other Name: Skull Grip bone fixation
  • Device: sutures
    Standard skull bon flap fixation, sutures
    Other Name: Standard skull bon flap fixation, sutures
  • Experimental: 1
    Skull Grip bone fixation
    Intervention: Device: Skull Grip bone fixation
  • Active Comparator: 2
    Standard skull bon flap fixation, sutures
    Intervention: Device: sutures
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00797979
P080501
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Salvatore CHIBBARO, MD Hôpital Lariboisière, Neurochirurgie
Assistance Publique - Hôpitaux de Paris
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP