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

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ClinicalTrials.gov Identifier: NCT00797979
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : November 27, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implant System for Fixation of Cranial Bone Flaps After Craniotomy for Brain Surgery
Study Start Date : October 2009
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu
U.S. FDA Resources

Arms and Interventions

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 Name: Standard skull bon flap fixation, sutures


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the efficacy of the "Skull Grip" new system of cranial flap fixation [ Time Frame: 2009 ]

Secondary Outcome Measures :
  1. To evaluate the security of "Skull Grip" new system of cranial flap fixation [ Time Frame: 2009 ]
  2. Compare functional benefits (ease and speed of implementation) of "Skull Grip" new system of cranial flap fixation compared with traditional sutures [ Time Frame: 2009 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012

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