CompletedPhase 1

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

France16 participantsStarted 2009-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Major patient (aged ≥ 18 years)
✓. Patient scheduled for craniotomy for a benign tumor
✓. Patient informed and have signed informed consent

Exclusion criteria

✕. 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

What they're measuring

To evaluate the efficacy of the "Skull Grip" new system of cranial flap fixation

Timeframe: 2009

Trial details

NCT IDNCT00797979

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-07

View on ClinicalTrials.gov More Skull Fixation After Craniotomy for Neurosurgical Procedures trials