Skull Fixation After Craniotomy for Neurosurgical ProceduresPhase 1CRANIOSGNCT00797979
Implant System for Fixation of Cranial Bone Flaps After Craniotomy for Brain Surgery
A Phase 1 study testing Skull Grip bone fixation and sutures in people with Skull Fixation After Craniotomy for Neurosurgical Procedures, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skull Fixation After Craniotomy for Neurosurgical Procedures
- What is being tested?
- Skull Grip bone fixation and sutures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Jul 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patient (aged ≥ 18 years)
- Patient scheduled for craniotomy for a benign tumor
- Patient informed and have signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Lariboisière, AP-HP, Neurochirurgie
Paris, Île-de-France Region, 75010
About this study
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.
Read the detailed 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.
- Being tested
- Skull Grip bone fixation, sutures
- Keywords
- Craniotomy, Skull fixation, Skull Grip, Reconstructive cranial surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skull Grip bone fixationDevice
Skull Grip bone fixation
suturesDevice
Also called Standard skull bon flap fixation, sutures
Standard skull bon flap fixation, sutures
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Skull Grip bone fixation Receives: Device: Skull Grip bone fixation |
| 2 | Active comparator | Standard skull bon flap fixation, sutures Receives: Device: sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of the "Skull Grip" new system of cranial flap fixation
Measured: 2009
Secondary outcomes (2)
To evaluate the security of "Skull Grip" new system of cranial flap fixation
Measured: 2009
Compare functional benefits (ease and speed of implementation) of "Skull Grip" new system of cranial flap fixation compared with traditional sutures
Measured: 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skull Fixation After Craniotomy for Neurosurgical ProceduresStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salvatore CHIBBARO, MD, Principal investigator, Hôpital Lariboisière, Neurochirurgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797979
- Sponsor's protocol ID
- P080501
- Acronym
- CRANIOSG
- Status last verified
- Nov 2012
- First submitted
- 24 Nov 2008
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22278799
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant System for Fixation of Cranial Bone Flaps After Craniotomy for Brain Surgery
- ClinicalTrials.gov ID
- NCT00797979
- Acronym / sponsor ID
- CRANIOSG / P080501
- Keywords
- Craniotomy, Skull fixation, Skull Grip, Reconstructive cranial surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 25 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Skull Grip bone fixationSkull Grip bone fixation |
| 2 | Active comparator | Device: suturesStandard skull bon flap fixation, sutures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major patient (aged ≥ 18 years)
- Patient scheduled for craniotomy for a benign tumor
- Patient informed and have signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skull Grip bone fixationSkull Grip bone fixation | Device | 1 |
| suturesAlso: Standard skull bon flap fixation, suturesStandard skull bon flap fixation, sutures | Device | 2 |
Primary outcome
To evaluate the efficacy of the "Skull Grip" new system of cranial flap fixation
Time frame: 2009
2 secondary outcomes
To evaluate the security of "Skull Grip" new system of cranial flap fixation
Time frame: 2009
Compare functional benefits (ease and speed of implementation) of "Skull Grip" new system of cranial flap fixation compared with traditional sutures
Time frame: 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
- Results publication: PubMed 22278799Chibbaro 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvatore CHIBBARO, MD principal investigator
Hôpital Lariboisière, Neurochirurgie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Skull Grip bone fixation and sutures in people with Skull Fixation After Craniotomy for Neurosurgical Procedures, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of the "Skull Grip" new system of cranial flap fixation (time frame: 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00797979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.