Skull Fixation After Craniotomy for Neurosurgical Procedures
Conditions
Keywords
Craniotomy, Skull fixation, Skull Grip, Reconstructive cranial surgery
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.
Interventions
DEVICESkull Grip bone fixation
Skull Grip bone fixation
DEVICEsutures
Standard skull bon flap fixation, sutures
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of the Skull Grip new system of cranial flap fixation | 2009 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed