Efficacy and Safety of 3D-Printed PEEK Skull Implants in Cranioplasty

Launched by CIMET SCIENTIFIC CORPORATION · Jan 16, 2025

Keywords

ClinConnect Summary

The aim of this study is to evaluate the efficacy and safety of personalized skull implants made of polyetheretheretherketone (PEEK) using three-dimensional printing in patients undergoing cranioplasty. This is a phase II clinical trial, with a single group of 30 patients who have suffered cranial bone loss. Specific objectives include analyzing the incidence of complications (infections, fractures, implant exposure), assessing functional recovery using recognized scales such as the Glasgow and Barthel scales, and measuring patient and surgeon aesthetic satisfaction over 12 months.

The des...

Gender

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Eligibility criteria

• 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 significant coagulopathy.
• * Patients with uncontrolled diabetes according to, ADA criteria:
• • o fasting glucose ≥ 200 mg/dL, HbA1C ≥ 8.5% in the last 3 months.
• • Patients with a body mass index (BMI) ≥ 35 kg/m
• • History of steroid drugs at least 3 months before surgery.
• • Women breastfeeding or pregnant.
• • Inability to read and understand the participant's information.
• • Prior participation in any related investigational drug or device study within 30 days.