Efficacy and Safety of 3D-Printed PEEK Skull Implants in Cranioplasty (NCT06782711) | Clinical Trial Compass
By InvitationNot Applicable
Efficacy and Safety of 3D-Printed PEEK Skull Implants in Cranioplasty
Mexico30 participantsStarted 2025-01
Plain-language summary
The goal of this clinical trial is to determine the efficacy and safety of customized skull implants made of polyetheretheretherketone by three-dimensional printing in patients undergoing cranioplasty. The main question it aims to answer is:
• Are customized skull implants made of polyetheretheretherketone using 3D printing effective and safe in patients undergoing cranioplasty?
Participants will:
* The patient will be submitted to cranioplasty.
* The patient will answer the neurological scales at each visit.
* Keep a diary of their symptoms and concomitant medications
* The study will be divided into 5 visits to the center, the surgical intervention and 3 telephone calls where patients will be followed up.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults \>18 years old.
* Both sexes.
* Who agree to participate and sign the informed consent form.
* With loss of a bone segment.
* Area of bone segment loss greater than 1 cm.
* Glasgow Coma Scale score equal to or greater than 9.
* Satisfactory preoperative evaluation
Exclusion Criteria:
* Presence of local infection at the craniotomy site or any type of systemic infection at the time of medical evaluation and systemic infection at the time of medical evaluation and during surgery.
* Presence of previous surgical instruments in the cranioplasty site.
* Need to use two or more implants for the reconstruction.
* The resulting angle between the tangential lines to the curvature of the implant and the tangent determined to the center of the implant, determined to the center of the implant, is greater than 50º.
* Patients whose cranial morphology presents difficulties for the prosthesis design.
* Presence of postoperative ossifications in the defect area.
* History of hypersensitivity to biomaterials.
* Surgery at the same site within the 6 months prior to the study surgery.
* Patients with any diagnosis that affects blood supply and bone quality.
* Patients who have received chemotherapy or radiotherapy in the surgical region that ended within 6 months prior to the planned surgery or are scheduled for the next 12 weeks.
* Diagnosis of malignant cranial tumor.
* History of any status epilepticus.
* Known history of hemophilia or other clinically signifi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency and causes of cranioplasty revisions
Timeframe: From enrollment to the end of treatment at 12 months