Cerebral Decompression InjuryNCT03218150
Cranioplasty: Autogenous Bone Graft Versus Artificial Substitutes
An observational study of Cerebral Decompression Injury, run by Assiut University.
Trial summary
Prospective, comparative, observational study. The project's aim is long term follow up of patient's having skull bone defects due to traumatic or lesion resection causes, treated , in standard clinical practice, with autologous bone graft , bone cement or titanium mesh and to compare the clinical outcome and safety… Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Cerebral Decompression Injury
- What is being tested?
- cranioplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Oct 2018
- 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 10 to 60 years
- All sexes
- Child, Adult
Study population: Patient's that need cranioplasty surgery admitted in assiut university hospital
Who may be able to join
- All patients that have reconstructive surgery of cranial defects due to traumatic or lesion resection causes .
- Age older than 10 and less than 60 years
- Provided written informed consent
Who cannot join
- Cases of cranial defects due to congenital anomalies or growing skull fractures .
- Severe disease with limited life expectancy of less than one year
About this study
Prospective, comparative, observational study.
The project's aim is long term follow up of patient's having skull bone defects due to traumatic or lesion resection causes, treated , in standard clinical practice, with autologous bone graft , bone cement or titanium mesh and to compare the clinical outcome and safety among the 3 types of treatment.
Eligibility to each treatment will respect the standard clinical practice.
Primary outcome: minimize post operative infection
Secondary outcomes: decrease operation time , clinical and psychological improvement of the patient, decrease the cost on the patient
Read the detailed description
Cranioplasty is the surgical intervention to repair cranial defects. The aim of cranioplasty is not only a cosmetic issue; also, the repair of cranial defects gives relief to psychological drawbacks and increases the social performances. Many different types of materials were used throughout the history of cranioplasty. With the evolving biomedical technology, new materials are available to be used by the surgeons. Although many different materials and techniques had been described, ongoing researches on both biologic and non biologic substitutions continue aiming to develop the ideal reconstruction material.
Autologous bone grafts remain the best option for adult and pediatric patients with viable donor sites and small-to-medium defects. Large defects in the adult population can be reconstructed with titanium mesh and polymethylmethacrylate overlay with or without the use of computer-assisted design and manufacturing customization. Advances in alloplastic materials and custom manufacturing of implants will have an important influence on cranioplasty techniques in the years to come.
- Conditions
- Cerebral Decompression Injury
- Being tested
- cranioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cranioplastyProcedure or surgery
. The margins of the craniectomy defects exposed, and the bone flaps fixed in their original positions using wires or titanium plates with screws. As prophylaxis, all patients intravenously administered with pre- and postoperative antibiotics.
In cases of artificial substitutes , The polymethyemethacrylate implant fixed to the defective region with titanium plates and self-tapping screws.
| Study group | Role | What they receive |
|---|---|---|
| bone cement group | patient underwent to cranioplasty reconstruction with customized hydroxyapatite prosthesis Receives: Procedure: cranioplasty | |
| titanium mesh group | patient underwent to cranioplasty reconstruction with titanium mesh Receives: Procedure: cranioplasty | |
| autologous bone group | patient underwent to cranioplasty reconstruction with autologous bone graft Receives: Procedure: cranioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety : minimize incidence of infection
incidence of adverse events ((infection, reabsorption))
Measured: 360 days after surgery
Secondary outcomes (1)
efficacy
quality of life improvement evaluation : (( glasgow coma score))
Measured: 60 , 120 , 360 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study startOct 2016
- Primary completionMar 2018 (estimated)
- Study completionOct 2018 (estimated)
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.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaeddin Mohamed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218150
- Sponsor's protocol ID
- Assiut cranioplasty
- Status last verified
- Jul 2017
- First submitted
- 11 Jul 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranioplasty: Autogenous Bone Graft Versus Artificial Substitutes
- ClinicalTrials.gov ID
- NCT03218150
- Acronym / sponsor ID
- Assiut cranioplasty
- Conditions
- Cerebral Decompression Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 14 Jul 2017 (actual)
- 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.
Prospective, comparative, observational study.
The project's aim is long term follow up of patient's having skull bone defects due to traumatic or lesion resection causes, treated , in standard clinical practice, with autologous bone graft , bone cement or titanium mesh and to compare the clinical outcome and safety among the 3 types of treatment.
Eligibility to each treatment will respect the standard clinical practice.
Primary outcome: minimize post operative infection
Secondary outcomes: decrease operation time , clinical and psychological improvement of the patient, decrease the cost on the patient
Detailed description
Cranioplasty is the surgical intervention to repair cranial defects. The aim of cranioplasty is not only a cosmetic issue; also, the repair of cranial defects gives relief to psychological drawbacks and increases the social performances. Many different types of materials were used throughout the history of cranioplasty. With the evolving biomedical technology, new materials are available to be used by the surgeons. Although many different materials and techniques had been described, ongoing researches on both biologic and non biologic substitutions continue aiming to develop the ideal reconstruction material.
Autologous bone grafts remain the best option for adult and pediatric patients with viable donor sites and small-to-medium defects. Large defects in the adult population can be reconstructed with titanium mesh and polymethylmethacrylate overlay with or without the use of computer-assisted design and manufacturing customization. Advances in alloplastic materials and custom manufacturing of implants will have an important influence on cranioplasty techniques in the years to come.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bone cement group | – | Procedure: cranioplastypatient underwent to cranioplasty reconstruction with customized hydroxyapatite prosthesis |
| titanium mesh group | – | Procedure: cranioplastypatient underwent to cranioplasty reconstruction with titanium mesh |
| autologous bone group | – | Procedure: cranioplastypatient underwent to cranioplasty reconstruction with autologous bone graft |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patient's that need cranioplasty surgery admitted in assiut university hospital
Key inclusion criteria (3 listed)
- All patients that have reconstructive surgery of cranial defects due to traumatic or lesion resection causes .
- Age older than 10 and less than 60 years
- Provided written informed consent
Key exclusion criteria (2 listed)
- Cases of cranial defects due to congenital anomalies or growing skull fractures .
- Severe disease with limited life expectancy of less than one year
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 |
|---|---|---|
| cranioplasty. The margins of the craniectomy defects exposed, and the bone flaps fixed in their original positions using wires or titanium plates with screws. As prophylaxis, all patients intravenously administered with pre- and postoperative antibiotics. In cases of artificial substitutes , The polymethyemethacrylate implant fixed to the defective region with titanium plates and self-tapping screws. | Procedure or surgery | autologous bone group, bone cement group, titanium mesh group |
Primary outcome
safety : minimize incidence of infection
Time frame: 360 days after surgery
incidence of adverse events ((infection, reabsorption))
1 secondary outcome
efficacy
Time frame: 60 , 120 , 360 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Decompression Injury, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 14 Jul 2017. 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?
Results are not available in the source record.
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 : minimize incidence of infection (time frame: 360 days 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 14 Jul 2017.