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

NCT06782711 | Enrolling By Invitation DMC

• 1 other identifier: CIMET-2024-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cranial Defects

Keywords

Cranioplasty; Custom implants; Polyetheretheretherketone (PEEK); Three-dimensional (3D) printing; Neurosurgery; Cranial prostheses; Medical devices

Outcome Measures

Primary Outcomes (1)

• Frequency and causes of cranioplasty revisions

  Cranioplasty revision is performed when it is necessary to correct or adjust a previously placed implant, either due to complications adjust a previously placed implant, either due to complications, lack of integration of the implant or changes in the desired form and function.

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (10)

• Infection at the implant site

  From enrollment to 3 months after surgery

• Frequency of surgery-associated infections

  From enrollment to 3 months after surgery

• Frequency of implant exposure

  From enrollment to the end of treatment at 12 months

• Frequency and type of implant fractures

  From enrollment to the end of treatment at 12 months

• Level of consciousness

  From enrollment to 3 months after surgery

Study Arms (1)

cranioplasty using customized skull implants made of polyetheretheretherketone using 3D printing

EXPERIMENTAL

All participants will undergo cranioplasty using customized skull implants made of polyetheretheretherketone using 3D printing

Procedure: cranioplasty; Device: customized skull implants made of polyetheretheretherketone (PEEK) using 3D printing

Interventions

cranioplasty PROCEDURE

In this pivotal study of a medical device, patients with bone loss undergo a computed tomography scan, which is used to create a three-dimensional model of the lesion. After validation, the model is printed using PEEK material, and subsequently, the skull is repaired through cranial reconstruction (cranioplasty).

cranioplasty using customized skull implants made of polyetheretheretherketone using 3D printing

customized skull implants made of polyetheretheretherketone (PEEK) using 3D printing DEVICE

customized skull implants made of polyetheretheretherketone by three-dimensional printing in patients undergoing cranioplasty

cranioplasty using customized skull implants made of polyetheretheretherketone using 3D printing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CIMET SCIENTIFIC CORPORATION: lead
• Consejo Nacional de Humanidades, Ciencias y Tecnologias (CONAHCYT): collaborator

Study Sites (1)

Centro de Investigación Clínica y Medicina Traslacional (CIMET)

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (7)

• Yang J, Sun T, Yuan Y, Li X, Yu H, Guan J. Evaluation of titanium mesh cranioplasty and polyetheretherketone cranioplasty: protocol for a multicentre, assessor-blinded, randomised controlled trial. BMJ Open. 2019 Dec 3;9(12):e033997. doi: 10.1136/bmjopen-2019-033997.

  PMID: 31796495 BACKGROUND

• Sharma N, Aghlmandi S, Dalcanale F, Seiler D, Zeilhofer HF, Honigmann P, Thieringer FM. Quantitative Assessment of Point-of-Care 3D-Printed Patient-Specific Polyetheretherketone (PEEK) Cranial Implants. Int J Mol Sci. 2021 Aug 7;22(16):8521. doi: 10.3390/ijms22168521.

  PMID: 34445228 BACKGROUND

• Mozaffari K, Rana S, Chow A, Mahgerefteh N, Duong C, Sheppard JP, Phillips HW, Jarrahy R, Yang I. Customized polyetheretherketone (PEEK) implants are associated with similar hospital length of stay compared to autologous bone used in cranioplasty procedures. J Neurol Sci. 2022 Mar 15;434:120169. doi: 10.1016/j.jns.2022.120169. Epub 2022 Jan 24.

  PMID: 35134672 BACKGROUND

• Henry J, Amoo M, Taylor J, O'Brien DP. Complications of Cranioplasty in Relation to Material: Systematic Review, Network Meta-Analysis and Meta-Regression. Neurosurgery. 2021 Aug 16;89(3):383-394. doi: 10.1093/neuros/nyab180.

  PMID: 34100535 BACKGROUND

• Csamer L, Csernatony Z, Novak L, Kovari VZ, Kovacs AE, Soosne Horvath H, Mano S. Custom-made 3D printing-based cranioplasty using a silicone mould and PMMA. Sci Rep. 2023 Jul 25;13(1):11985. doi: 10.1038/s41598-023-38772-9.

  PMID: 37491550 BACKGROUND

• Basgul C, Yu T, MacDonald DW, Siskey R, Marcolongo M, Kurtz SM. Structure-Property Relationships for 3D printed PEEK Intervertebral Lumbar Cages Produced using Fused Filament Fabrication. J Mater Res. 2018 Jul 27;33(14):2040-2051. doi: 10.1557/jmr.2018.178. Epub 2018 Jun 18.

  PMID: 30555210 BACKGROUND

• Alkhaibary 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.

  PMID: 32387405 BACKGROUND

Study Officials

• Geannyne Villegas Rivera, MD, PhD, MBA

  Centro de Investigación Clínica y Medicina Traslacional (CIMET)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 20, 2025
• Study Start: January 1, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

ME (1)