Bone DefectsPhase 2NCT06662903
Cranioplasty Using Titanium Mesh vs Bone Cement
A Phase 2 study testing Cranioplasty with Titanium mesh and Cranioplasty with bone cement in people with Bone Defects and Decompressive Craniectomy and Cranioplasty, run by Osman Hassan Osman Zafraan at 1 site in Egypt.
Trial summary
The aim of this study is: To compare the surgical outcomes between titanium mesh and bone cement in cranioplasty. To assess the complication rates associated with each material. To evaluate patient satisfaction and aesthetic results post-surgery Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Defects, Decompressive Craniectomy and Cranioplasty, Cranioplasty
- What is being tested?
- Cranioplasty with Titanium mesh and Cranioplasty with bone cement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2024to May 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients requiring cranioplasty for a skull defect due to Decompressive Craniectomy, trauma, tumor resection, or congenital issues.
- All ages .
- Both sex.
- Informed consent obtained from all participants.
- Patient fit for surgery.
Who cannot join
- Patients with active infection at the surgical site
- Patient Unfit for surgery.
- Patient refuse consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Comparative Study Between Cranioplasty Using Titanium Mesh vs Bone Cement
The aim of this study is:
To compare the surgical outcomes between titanium mesh and bone cement in cranioplasty.
To assess the complication rates associated with each material. To evaluate patient satisfaction and aesthetic results post-surgery
Read the detailed description
Cranioplasty is a common neurosurgical procedure performed to repair skull vault defects.
The skull vault defects may result mostly after traumatic injuries as depressed skull fractures, Tumor removal (infiltrating skull bones), decompressive craniectomies, congenital anomalies or inflammatory lesions.
At present, there is no gold standard material for cranioplasty with the use of autologous bone as well as other synthetic materials as bone cement and titanium mesh.
Bone cement is malleable, lightweight, strong, and heat resistant, but it may cause burn injury during the process of its preparation and is used for relatively small defects.
Titanium mesh good mechanical strength, a low infection rate, and an acceptable cost but may cause metal allergy, tissue erosion, implant exposure, and deformity upon application of external force.
Cranioplasty not only provides Brain protection and cosmetic aspects but also, decrease incidence of epilepsy, relief to psychological drawbacks and increases social performance, restoring the dynamics of CSF.
- Being tested
- Cranioplasty with Titanium mesh, Cranioplasty with bone cement
- Keywords
- Cranioplasty, Titanium mesh, Bone cement, Traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranioplasty with Titanium meshProcedure or surgery
Cranioplasty using titanium mesh
Cranioplasty with bone cementProcedure or surgery
Cranioplasty using bone cement
| Study group | Role | What they receive |
|---|---|---|
| Titanium mesh | Active comparator | this group is operated using titanium mesh Receives: Procedure: Cranioplasty with Titanium mesh |
| Bone cement | Active comparator | this group is operated using bone cement Receives: Procedure: Cranioplasty with bone cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction using patient ssatisfaction grade
Patients satisfaction (cosmetic, psychological, neurologic ) measered by validate questionnaire post-opeartive and follow up using Patient satisfaction grade from Excellent to not satisfied
Measured: through study completion, an average 1 years
Secondary outcomes (4)
Infection
follow up rate of post operative infection
Measured: through study completion, an average 1 years
Reoperation
rate of reoperation after using each material a post-operative follow up
Measured: through study completion, an average 1 years
CSF leak
post-operative complication of CSF leak due to changes in Dynamics of CSF flow
Measured: through study completion, an average 1 years
complications
post-operative as hematoma formation , neurologic defict and fits.
Measured: through study completion, an average 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bone DefectsStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Titanium mesh VS Bone cement in Cranioplasty
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osman Hassan Osman Zafraan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Osman Hassan Osman Zafraan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662903
- Sponsor's protocol ID
- Cranioplasty
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mousa M, Eissa S, Raslan M, Abu ElNaga B, Balaha A. Evaluation of three different methods of cranioplasty; a comparative prospective randomized study. Pan Arab Journal of Neurosurgery. 2021;16
Andrabi SM, Sarmast AH, Kirmani AR, Bhat AR. Cranioplasty: Indications, procedures, and outcome - An institutional experience. Surg Neurol Int. 2017 May 26;8:91. doi: 10.4103/sni.sni_45_17. eCollection 2017.
PubMed 28607825Capitelli-McMahon H, Kahlar N, Rahman S. Titanium Versus Autologous Bone-Based Cranioplasty: A Systematic Review and Meta-Analysis. Cureus. 2023 May 26;15(5):e39516. doi: 10.7759/cureus.39516. eCollection 2023 May.
PubMed 37366436Aydin S, Kucukyuruk B, Abuzayed B, Aydin S, Sanus GZ. Cranioplasty: Review of materials and techniques. J Neurosci Rural Pract. 2011 Jul;2(2):162-7. doi: 10.4103/0976-3147.83584.
PubMed 21897681Alkhaibary A, Alharbi A, Alnefaie N, Oqalaa Almubarak A, Aloraidi A, Khairy S. Cranioplasty: A Comprehensive Review of the History, Materials, Surgical Aspects, and Complications. World Neurosurg. 2020 Jul;139:445-452. doi: 10.1016/j.wneu.2020.04.211. Epub 2020 May 6.
PubMed 32387405
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Cranioplasty Using Titanium Mesh vs Bone Cement
- ClinicalTrials.gov ID
- NCT06662903
- Acronym / sponsor ID
- Cranioplasty
- Keywords
- Cranioplasty, Titanium mesh, Bone cement, Traumatic brain injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Osman Hassan Osman ZafraanUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 29 Oct 2024 (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.
The aim of this study is:
To compare the surgical outcomes between titanium mesh and bone cement in cranioplasty.
To assess the complication rates associated with each material. To evaluate patient satisfaction and aesthetic results post-surgery
Detailed description
Cranioplasty is a common neurosurgical procedure performed to repair skull vault defects.
The skull vault defects may result mostly after traumatic injuries as depressed skull fractures, Tumor removal (infiltrating skull bones), decompressive craniectomies, congenital anomalies or inflammatory lesions.
At present, there is no gold standard material for cranioplasty with the use of autologous bone as well as other synthetic materials as bone cement and titanium mesh.
Bone cement is malleable, lightweight, strong, and heat resistant, but it may cause burn injury during the process of its preparation and is used for relatively small defects.
Titanium mesh good mechanical strength, a low infection rate, and an acceptable cost but may cause metal allergy, tissue erosion, implant exposure, and deformity upon application of external force.
Cranioplasty not only provides Brain protection and cosmetic aspects but also, decrease incidence of epilepsy, relief to psychological drawbacks and increases social performance, restoring the dynamics of CSF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Titanium mesh VS Bone cement in Cranioplasty
| Arm | Type | Receives |
|---|---|---|
| Titanium mesh | Active comparator | Procedure: Cranioplasty with Titanium meshthis group is operated using titanium mesh |
| Bone cement | Active comparator | Procedure: Cranioplasty with bone cementthis group is operated using bone cement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (3 listed)
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 with Titanium meshCranioplasty using titanium mesh | Procedure or surgery | Titanium mesh |
| Cranioplasty with bone cementCranioplasty using bone cement | Procedure or surgery | Bone cement |
Primary outcome
Patient satisfaction using patient ssatisfaction grade
Time frame: through study completion, an average 1 years
Patients satisfaction (cosmetic, psychological, neurologic ) measered by validate questionnaire post-opeartive and follow up using Patient satisfaction grade from Excellent to not satisfied
4 secondary outcomes
Infection
Time frame: through study completion, an average 1 years
Reoperation
Time frame: through study completion, an average 1 years
CSF leak
Time frame: through study completion, an average 1 years
complications
Time frame: through study completion, an average 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Results publicationMousa M, Eissa S, Raslan M, Abu ElNaga B, Balaha A. Evaluation of three different methods of cranioplasty; a comparative prospective randomized study. Pan Arab Journal of Neurosurgery. 2021;16
- Results publication: PubMed 28607825Andrabi SM, Sarmast AH, Kirmani AR, Bhat AR. Cranioplasty: Indications, procedures, and outcome - An institutional experience. Surg Neurol Int. 2017 May 26;8:91. doi: 10.4103/sni.sni_45_17. eCollection 2017.
- Results publication: PubMed 37366436Capitelli-McMahon H, Kahlar N, Rahman S. Titanium Versus Autologous Bone-Based Cranioplasty: A Systematic Review and Meta-Analysis. Cureus. 2023 May 26;15(5):e39516. doi: 10.7759/cureus.39516. eCollection 2023 May.
- Results publication: PubMed 21897681Aydin S, Kucukyuruk B, Abuzayed B, Aydin S, Sanus GZ. Cranioplasty: Review of materials and techniques. J Neurosci Rural Pract. 2011 Jul;2(2):162-7. doi: 10.4103/0976-3147.83584.
- Results publication: PubMed 32387405Alkhaibary A, Alharbi A, Alnefaie N, Oqalaa Almubarak A, Aloraidi A, Khairy S. Cranioplasty: A Comprehensive Review of the History, Materials, Surgical Aspects, and Complications. World Neurosurg. 2020 Jul;139:445-452. doi: 10.1016/j.wneu.2020.04.211. Epub 2020 May 6.
- Individual participant dataSharing planned: Undecided
Related trials for Bone Defects
Not yet recruitingEarly Phase 1
The Efficacy of Exosomes Combined With Synthetic Bone Graft for the Treatment of Periodontal Intra-bony Defects
Intra-Bony Defects in Periodontitis Patients
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
Recruiting
Subchondral Drilling Diameter During CARTISTEM Implantation for Knee Cartilage Defects
Osteoarthritis, Knee, Articular Cartilage Defects of the Knee
Recruiting
Effect of Changing Grafting Sequences During Sinus Lifting & Simultaneous Implant Placement in the Gained Bone Using Customized Surgical Guide
Vertical Bone Defects, Missing Tooth/Teeth
Active, not recruitingObservational study
Biomechanics of Metastatic Defects in Bone
Cancer Bone, Bone Tumors
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cranioplasty with Titanium mesh and Cranioplasty with bone cement in people with Bone Defects and Decompressive Craniectomy and Cranioplasty, run by Osman Hassan Osman Zafraan 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 29 Oct 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osman Hassan Zafraan, Resident doctor (+201220993578, docosmanhassan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction using patient ssatisfaction grade (time frame: through study completion, an average 1 years). 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 NCT06662903, which also lists 5 linked publications.
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 29 Oct 2024.