CranioplastyCranioplastyNCT04111562
Does Cranioplasty Reduce Disability in Cases With Post Traumatic Skull Bone Defects
A study testing Cranioplasty in people with Cranioplasty and Disability Physical, run by Assiut University at 1 site in Egypt.
Trial summary
Background: The percentage of permanent infirmities following traumatic cranial bone cranial bone defects following trauma for restoration of function and cosmoses. This study designed to evaluate the influence of cranioplasty as a method of skull repair on work capability of the patients and their employability. Read more about this study
- Who is it for?
- Ages 14 to 66 years
- Conditions the study is for
- Cranioplasty, Disability Physical, Trauma
- What is being tested?
- Cranioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2017to 3 Mar 2020
- Phase
- Interventional
- 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 66 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with traumatic skull bone defects
Who cannot join
- Patients were not working before trauma
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Emanaalah shaltouy@yahoo.com
Asyut, 71111
Eman S Shaltout, MD, 00201094149135, emansalahshaltout@yahoo.com
Wael M Abd-ElGhani, MD, 00201098196217, waelneuro@yahoo.com
About this study
Background: The percentage of permanent infirmities following traumatic cranial bone cranial bone defects following trauma for restoration of function and cosmoses. This study designed to evaluate the influence of cranioplasty as a method of skull repair on work capability of the patients and their employability.
Methods: The authors compared the work capability and employment of 35 patients with traumatic cranial bone defects after head trauma treated in the Neurosurgery Department of Assiut University Hospitals, Egypt from January 2013 to January 2018 before and after cranioplasty.
Read the detailed description
Cranioplasty is surgical repair of a cranial bone defect, important to cover defects following skull trauma for restoration of function, cosmoses and protective effects. Cranioplasty is the surgical procedure in which the autologous skull, synthetic materials (titanium, methyl methacrylate, polyetheretherketone implants, hydroxyapatite, and bioceramics are used to repair the skull defect
- Conditions
- Cranioplasty, Disability Physical, Trauma
- Being tested
- Cranioplasty
- Keywords
- Cranial defect, skull bone defects
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CranioplastyProcedure or surgery
Bone grafts
| Study group | Role | What they receive |
|---|---|---|
| polymethyl methacrylate Cranioplasty | Other | The Cranioplastic kit used (Teknimed, Biomaterials Innovation, Gentafix 1 ®, France) a biocompatible material that is composed of powder and liquid form of polymethyl methacrylate. Receives: Procedure: Cranioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with complications
the number of patients with complications after cranioplasty as a method of skull repair.
Measured: 6 months up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start3 Mar 2017
- Primary completion3 Mar 2020 (estimated)
- Study completion3 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CranioplastyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Salah Shaltout, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111562
- Sponsor's protocol ID
- Cranioplasty2018
- Other IDs
- Assiut University
- Acronym
- Cranioplasty
- Status last verified
- Sep 2019
- First submitted
- 25 Feb 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Cranioplasty Reduce Disability in Cases With Post Traumatic Skull Bone Defects
- ClinicalTrials.gov ID
- NCT04111562
- Acronym / sponsor ID
- Cranioplasty / Cranioplasty2018
- Conditions
- Cranioplasty, Disability Physical, Trauma
- Keywords
- Cranial defect, skull bone defects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 3 Mar 2020 (estimated)
- Study completion
- 3 Mar 2020 (estimated)
- First posted
- 1 Oct 2019 (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.
Background: The percentage of permanent infirmities following traumatic cranial bone cranial bone defects following trauma for restoration of function and cosmoses. This study designed to evaluate the influence of cranioplasty as a method of skull repair on work capability of the patients and their employability.
Methods: The authors compared the work capability and employment of 35 patients with traumatic cranial bone defects after head trauma treated in the Neurosurgery Department of Assiut University Hospitals, Egypt from January 2013 to January 2018 before and after cranioplasty.
Detailed description
Cranioplasty is surgical repair of a cranial bone defect, important to cover defects following skull trauma for restoration of function, cosmoses and protective effects. Cranioplasty is the surgical procedure in which the autologous skull, synthetic materials (titanium, methyl methacrylate, polyetheretherketone implants, hydroxyapatite, and bioceramics are used to repair the skull defect
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| polymethyl methacrylate Cranioplasty | Other | Procedure: CranioplastyThe Cranioplastic kit used (Teknimed, Biomaterials Innovation, Gentafix 1 ®, France) a biocompatible material that is composed of powder and liquid form of polymethyl methacrylate. |
Who may qualify
- Ages
- 14 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with traumatic skull bone defects
Key exclusion criteria (1 listed)
- Patients were not working before trauma
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 |
|---|---|---|
| CranioplastyBone grafts | Procedure or surgery | polymethyl methacrylate Cranioplasty |
Primary outcome
Number of participants with complications
Time frame: 6 months up to one year
the number of patients with complications after cranioplasty as a method of skull repair.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranioplasty in people with Cranioplasty and Disability Physical, run by Assiut University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Oct 2019. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with complications (time frame: 6 months up to one year). 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 1 Oct 2019.