Implant System for Fixation of Cranial Bone Flaps After Craniotomy for Brain Surgery
CRANIOSG
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2008
CompletedFirst Posted
Study publicly available on registry
November 25, 2008
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedNovember 27, 2012
November 1, 2012
9 months
November 24, 2008
November 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy of the "Skull Grip" new system of cranial flap fixation
2009
Secondary Outcomes (2)
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
Study Arms (2)
1
EXPERIMENTALSkull Grip bone fixation
2
ACTIVE COMPARATORStandard skull bon flap fixation, sutures
Interventions
Standard skull bon flap fixation, sutures
Eligibility Criteria
You may qualify if:
- Major patient (aged ≥ 18 years)
- Patient scheduled for craniotomy for a benign tumor
- Patient informed and have signed informed consent
You may not qualify if:
- Patient not affiliated with a social security scheme (or beneficiary entitled)
- Patient with a known allergy to titanium
- Patient non-compliant or whose follow-up to 3 months is impossible
- Patient with against-indication scanner
- Pregnant or lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Lariboisière, AP-HP, Neurochirurgie
Paris, Île-de-France Region, 75010, France
Related Publications (1)
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.
PMID: 22278799RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Salvatore CHIBBARO, MD
Hôpital Lariboisière, Neurochirurgie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2008
First Posted
November 25, 2008
Study Start
October 1, 2009
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
November 27, 2012
Record last verified: 2012-11