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OpenTrials
Completed

NCT Number: NCT00797979

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU Lariboisière, AP-HP, Neurochirurgie

Paris, Île-de-France Region, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skull Grip bone fixation

Device

Skull Grip bone fixation

sutures

Device

Standard skull bon flap fixation, sutures

Other names: Standard skull bon flap fixation, sutures

Primary outcomes

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

    Time frame: 2009

Secondary outcomes

  1. To evaluate the security of "Skull Grip" new system of cranial flap fixation

    Time frame: 2009

  2. Compare functional benefits (ease and speed of implementation) of "Skull Grip" new system of cranial flap fixation compared with traditional sutures

    Time frame: 2009

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: CRANIOSG

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 25, 2008
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.