SurgeryCUSTOMBONENCT01824706
Prospective, Multicenter Observational Study Evaluating the Long Term Safety of the Custombone Implant
An observational study of Surgery, run by Integra LifeSciences Corporation at 18 sites in France.
Trial summary
A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™ The patients will be included as soon as they are implanted and follow-up for 2 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery
- What is being tested?
- craniectomy
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 18 sitesFrance
- Study dates
- 1 Dec 2012to 1 May 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patient implanted with the Custombone prosthesis
Who may be able to join
- Patient planning to have a cranioplasty and be implanted with the Custombone™ medical device
- Patient who agrees to take part in the study, or agreement of a representative of the patient in case of patient inability, after being informed by the investigator and having received an information letter
Who cannot join
- Patient who does not accept to take part in the study after being informed
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
CH Amiens
Amiens
CHU Angers
Angers
CH de la cote basque
Bayonne
CHU la cavale blanche
Brest
CHU Beaujon
Clichy
CHU Henri Mondor
Créteil
CHRU Roger Salengro
Lille
CHU Lyon
Lyon
CHU Hotel Dieu
Nantes
CHU Pasteur
Nice
CHU Lariboisière
Paris
CHU La¨Pitié Salpêtrière
Paris
Hopital Maison Blanche
Reims
Hôpital Ponchaillou
Rennes
CH Saint Etienne
Saint-Etienne
CHU Hautepierre
Strasbourg
CH Bretonneau
Tours
Clinique du Tonkin
Villeurbanne
About this study
Official title: A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™
A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™
The patients will be included as soon as they are implanted and follow-up for 2 years. It is observational so no specific exam is planned.
The explantation rate will be measured, that is to say the number of patients whose prosthesis will be removed (with or without any relationship with the implant or the procedure).
- Conditions
- Surgery
- Being tested
- craniectomy
- Keywords
- cranial prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
craniectomyProcedure or surgery
craniectomy
| Study group | Role | What they receive |
|---|---|---|
| craniectomy | craniectomy Receives: Procedure: craniectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explantation rate after 2 years of follow-up
The main objective of the study is to measure the explantation rate after the implantation of a Custombone TM prosthesis. We will measure the number of patients whose prosthesis has an been removed, with or without any relationship with the implant or the procedure
Measured: 24 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study start1 Dec 2012
- Primary completion1 May 2016
- Study completion1 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- S Froelich, Principal investigator, Hospital Lariboisiere Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824706
- Sponsor's protocol ID
- NT-PMK-1201
- Acronym
- CUSTOMBONE
- Status last verified
- Jun 2018
- First submitted
- 25 Mar 2013
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™
- ClinicalTrials.gov ID
- NCT01824706
- Acronym / sponsor ID
- CUSTOMBONE / NT-PMK-1201
- Conditions
- Surgery
- Keywords
- cranial prosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 May 2016 (actual)
- First posted
- 5 Apr 2013 (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.
A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™
The patients will be included as soon as they are implanted and follow-up for 2 years. It is observational so no specific exam is planned.
The explantation rate will be measured, that is to say the number of patients whose prosthesis will be removed (with or without any relationship with the implant or the procedure).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| craniectomy | – | Procedure: craniectomycraniectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patient implanted with the Custombone prosthesis
Key inclusion criteria (2 listed)
- Patient planning to have a cranioplasty and be implanted with the Custombone™ medical device
- Patient who agrees to take part in the study, or agreement of a representative of the patient in case of patient inability, after being informed by the investigator and having received an information letter
Key exclusion criteria (1 listed)
- Patient who does not accept to take part in the study after being informed
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 |
|---|---|---|
| craniectomycraniectomy | Procedure or surgery | craniectomy |
Primary outcome
Explantation rate after 2 years of follow-up
Time frame: 24 months after implantation
The main objective of the study is to measure the explantation rate after the implantation of a Custombone TM prosthesis. We will measure the number of patients whose prosthesis has an been removed, with or without any relationship with the implant or the procedure
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 2 Jul 2018.
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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.
S Froelich principal investigator
Hospital Lariboisiere Paris
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Integra LifeSciences Corporation at 18 sites 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 2 inclusion and 1 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 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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.
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?
Explantation rate after 2 years of follow-up (time frame: 24 months after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2018.