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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Skull Grip bone fixation |
|
| 2 | Active Comparator | Standard skull bon flap fixation, sutures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skull Grip bone fixation | Device | Skull Grip bone fixation |
| |
| sutures |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of the "Skull Grip" new system of cranial flap fixation | 2009 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salvatore CHIBBARO, MD | Hôpital Lariboisière, Neurochirurgie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Lariboisière, AP-HP, Neurochirurgie | Paris | Île-de-France Region | 75010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22278799 | Result | 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. |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Device |
Standard skull bon flap fixation, sutures |
|
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