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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 1

Conditions: Skull Fixation After Craniotomy for Neurosurgical Procedures

Treatments: Device: sutures; Device: Skull Grip bone fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT00797979

P080501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

1

Experimental group

Description:

Skull Grip bone fixation

Treatment:

Device: Skull Grip bone fixation

2

Active Comparator group

Description:

Standard skull bon flap fixation, sutures

Treatment:

Device: sutures