Cerebral Decompression InjuryNCT01641523
Controlled Study in Cranioplasty Reconstruction
An observational study of Cerebral Decompression Injury and Cranioplasty, run by Azienda Ospedaliero-Universitaria di Parma.
Trial summary
Multicenter, prospective, comparative, observational study with regular follow-up visits. The project's aim is long-term follow-up of patients affected by large and complex craniolacuniae treated, in standard clinical practice, with CustomBone Service™ Cranial (porous bio-mimetic hydroxyapatite custom-made medical… Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Cerebral Decompression Injury, Cranioplasty
- What is being tested?
- CustomBone Service
- Type of treatment
- Medical device
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Sep 2011
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: consecutive patients,in different italian centres, requiring cranioplasty
Who may be able to join
- Patients which need cranial reconstruction,
- Cranioplasty reconstruction by autologous bone, hidroxyapatite or polymethylmethacrylate,
- Patients of both sex in age range between 14 and 75 years old,
- Craniolacuniae size > 25 cm2 ,
- Patients affected by complex pathologies or fracture or infection of a previous implant.
- Elegibility to CustomBone Service™ Cranial treatment will respect the product leaflet instructions.
- Each investigator will respect his own medical centre internal inclusion criteria to cranial reconstruction.
Who cannot join
- Patients affected by important emocoagulation pathologies,
- Patients affected by mellitus diabetes,
- Patients affected by autoimmune pathology,
- Patients unable to intend,
- Patients affected by immunodepression.
About this study
Official title: Multicenter Prospective Controlled Study in Cranioplasty Reconstruction
Multicenter, prospective, comparative, observational study with regular follow-up visits.
The project's aim is long-term follow-up of patients affected by large and complex craniolacuniae treated, in standard clinical practice, with CustomBone Service™ Cranial (porous bio-mimetic hydroxyapatite custom-made medical device for cranioplasty), autologous bone or polymethilmethacrylate customized prosthesis and to compare the clinical outcome and safety among the three treatments.
Read more
Elegibility to each treatment will respect the standard clinical practice. Each investigator will respect his own hospital criteria for cranial reconstruction.
Each centre's agreement to participate the study is totally voluntary.
The study sample size has not been defined on statistical criteria: the study population was set at 100 consecutive patients treated with cranioplasty reconstruction with one of the three foreseen group.
Each investigator will not be allowed to enrol more then 20 patients to avoid an enrolment imbalance between centres involved.
Primary study end-points are: evaluation of adverse event incidence after surgical treatment.
Secondary end-points are: quality of life improvement, evaluation of bone continuity restoration evaluated by CT scan analysis, neurological improvement.
Read the detailed description
Cranioplasty surgery is necessary everytime a craniolacuniae has to be reconstructed to ensure protection to the central nervous system. Cranioplasty surgery is classified into first line surgery, due to traumatic events or degenerative pathologies, and second line treatment, when due to first treatment failure, for example because of autologous bone reabsorption/infection or other material reject.
Clinical evaluation scores Specific and validated clinical scores will be employed for End-points evaluation.
CT scan will required in the pre-operation visit and in the post-operation time during the follow up visits to evaluate the bone-implant osteointegration process and osteointegration will be evaluated applying a specific score.
Data have been recorded in a e-CRF with limited access, protected by personal password.
Data will always be collected in an anonymous way, subjects identity will always be undisclosed.
Each patient will be asked to give informed consent to partecipate the study.
- Conditions
- Cerebral Decompression Injury, Cranioplasty
- Being tested
- CustomBone Service
- Keywords
- Cranioplasty prosthesis, Hydroxyapatite, PolyMethylMethacrylate, Autologous Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CustomBone ServiceDevice
Also called polymethylmethacrylate cranioplasty, autologous bone opercula
customized hydroxyapatite cranial prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Hydroxyapatite Cranioplasty | patient underwent to cranioplasty reconstruction with customized hydroxyapatite prosthesis Receives: Device: CustomBone Service | |
| polymethylmethacrylate | patient underwent to cranioplasty reconstruction with polymethylmethacrylate prosthesis Receives: Device: CustomBone Service | |
| autologous bone | patients underwent to cranioplasty reconstruction by autologous bone repositioning Receives: Device: CustomBone Service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
incidence of adverse event (infection, reabsorption, mobilization, fractures, dislocation) after surgical treatment
Measured: 360 day after surgery
Secondary outcomes (1)
Efficacy
Quality of life improvement evaluation: Disability Rating Scale(DRS); Neurological recovery evaluation: Neurological Objective Exam (EON), Glasgow Coma Scale (GCS), Glasgow Outcome Scale (GCS), motor deficit evaluation scale; Mechanical, biological and aesthetic outcome; CT scan evaluation;
Measured: 90, 180, 360, 720 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startJan 2007
- Primary completionJan 2007
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Decompression InjuryStudies 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Collaborators
- Fin-Ceramica Faenza Spa
- Responsible party
- Principal investigator, Franco Servadei, Azienda Ospedaliero-Universitaria di Parma
- Investigators
- Franco Servadei, Prof. MD, Study director, Maggiore Hospital Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641523
- Sponsor's protocol ID
- NEU02
- Status last verified
- Aug 2015
- First submitted
- 5 Jul 2012
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Controlled Study in Cranioplasty Reconstruction
- ClinicalTrials.gov ID
- NCT01641523
- Acronym / sponsor ID
- NEU02
- Conditions
- Cerebral Decompression Injury, Cranioplasty
- Keywords
- Cranioplasty prosthesis, Hydroxyapatite, PolyMethylMethacrylate, Autologous Bone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Collaborators
- Fin-Ceramica Faenza Spa
- Study start
- Jan 2007
- Primary completion
- Jan 2007 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 16 Jul 2012 (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.
Multicenter, prospective, comparative, observational study with regular follow-up visits.
The project's aim is long-term follow-up of patients affected by large and complex craniolacuniae treated, in standard clinical practice, with CustomBone Service™ Cranial (porous bio-mimetic hydroxyapatite custom-made medical device for cranioplasty), autologous bone or polymethilmethacrylate customized prosthesis and to compare the clinical outcome and safety among the three treatments.
Elegibility to each treatment will respect the standard clinical practice. Each investigator will respect his own hospital criteria for cranial reconstruction.
Each centre's agreement to participate the study is totally voluntary.
The study sample size has not been defined on statistical criteria: the study population was set at 100 consecutive patients treated with cranioplasty reconstruction with one of the three foreseen group.
Each investigator will not be allowed to enrol more then 20 patients to avoid an enrolment imbalance between centres involved.
Primary study end-points are: evaluation of adverse event incidence after surgical treatment.
Secondary end-points are: quality of life improvement, evaluation of bone continuity restoration evaluated by CT scan analysis, neurological improvement.
Detailed description
Cranioplasty surgery is necessary everytime a craniolacuniae has to be reconstructed to ensure protection to the central nervous system. Cranioplasty surgery is classified into first line surgery, due to traumatic events or degenerative pathologies, and second line treatment, when due to first treatment failure, for example because of autologous bone reabsorption/infection or other material reject.
Clinical evaluation scores Specific and validated clinical scores will be employed for End-points evaluation.
CT scan will required in the pre-operation visit and in the post-operation time during the follow up visits to evaluate the bone-implant osteointegration process and osteointegration will be evaluated applying a specific score.
Data have been recorded in a e-CRF with limited access, protected by personal password.
Data will always be collected in an anonymous way, subjects identity will always be undisclosed.
Each patient will be asked to give informed consent to partecipate the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydroxyapatite Cranioplasty | – | Device: CustomBone Servicepatient underwent to cranioplasty reconstruction with customized hydroxyapatite prosthesis |
| polymethylmethacrylate | – | Device: CustomBone Servicepatient underwent to cranioplasty reconstruction with polymethylmethacrylate prosthesis |
| autologous bone | – | Device: CustomBone Servicepatients underwent to cranioplasty reconstruction by autologous bone repositioning |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- consecutive patients,in different italian centres, requiring cranioplasty
Key inclusion criteria (7 listed)
- Patients which need cranial reconstruction,
- Cranioplasty reconstruction by autologous bone, hidroxyapatite or polymethylmethacrylate,
- Patients of both sex in age range between 14 and 75 years old,
- Craniolacuniae size > 25 cm2 ,
- Patients affected by complex pathologies or fracture or infection of a previous implant.
Key exclusion criteria (5 listed)
- Patients affected by important emocoagulation pathologies,
- Patients affected by mellitus diabetes,
- Patients affected by autoimmune pathology,
- Patients unable to intend,
- Patients affected by immunodepression.
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 |
|---|---|---|
| CustomBone ServiceAlso: polymethylmethacrylate cranioplasty, autologous bone operculacustomized hydroxyapatite cranial prosthesis | Device | Hydroxyapatite Cranioplasty, autologous bone, polymethylmethacrylate |
Primary outcome
Safety
Time frame: 360 day after surgery
incidence of adverse event (infection, reabsorption, mobilization, fractures, dislocation) after surgical treatment
1 secondary outcome
Efficacy
Time frame: 90, 180, 360, 720 days after the surgery
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 19 Aug 2015.
Related trials for Cerebral Decompression Injury
Active, not recruitingObservational study
Feasibility and Outcomes of 3D-printed External Cranial Orthosis After Craniectomy
Traumatic Brain Injury, Acquired Brain Injury
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.
Franco Servadei, Prof. MD study director
Maggiore Hospital Parma
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Decompression Injury and Cranioplasty, run by Azienda Ospedaliero-Universitaria di Parma.
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 7 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Safety (time frame: 360 day after surgery). 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 19 Aug 2015.