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

NCT00797979 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2012-11-27

No results posted yet for this study

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.

Conditions

  • Skull Fixation After Craniotomy for Neurosurgical Procedures

Interventions

DEVICE

Skull Grip bone fixation

Skull Grip bone fixation

DEVICE

sutures

Standard skull bon flap fixation, sutures

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Salvatore CHIBBARO, MD · Hôpital Lariboisière, Neurochirurgie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00797979 on ClinicalTrials.gov