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
  Purpose

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.


Condition Intervention Phase
Skull Fixation After Craniotomy for Neurosurgical Procedures
Device: Skull Grip bone fixation
Device: sutures
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Implant System for Fixation of Cranial Bone Flaps After Craniotomy for Brain Surgery

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • To evaluate the efficacy of the "Skull Grip" new system of cranial flap fixation [ Time Frame: 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: October 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Skull Grip bone fixation
Device: Skull Grip bone fixation
Skull Grip bone fixation
Other Name: Skull Grip bone fixation
Active Comparator: 2
Standard skull bon flap fixation, sutures
Device: sutures
Standard skull bon flap fixation, sutures
Other Name: Standard skull bon flap fixation, 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797979

Locations
France
CHU Lariboisière, AP-HP, Neurochirurgie
Paris, Ile De France, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Salvatore CHIBBARO, MD Hôpital Lariboisière, Neurochirurgie
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00797979     History of Changes
Other Study ID Numbers: P080501
Study First Received: November 24, 2008
Last Updated: November 23, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Craniotomy
Skull fixation
Skull Grip
Reconstructive cranial surgery

ClinicalTrials.gov processed this record on July 23, 2014