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.
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 design includes multiple follow-up visits, from surgery to one year after, where neurological, functional and cosmetic assessments will be performed. The selection and exclusion criteria ensure the suitability of the participants, while the variables monitored allow a comprehensive analysis of the results, from cognitive functionality to surgical complications. This study seeks to provide scientific evidence to support the implementation of this technology in patients with cranial defects, improving both quality of life and post-surgical aesthetic and functional outcomes. -Main inclusion criteria: Being older than 18 years, of both sexes. Loss of cranial bone segment greater than 1 cm². Glasgow Coma Scale (GCS) score equal or greater than 9. Satisfactory pre-surgical evaluation. Signed informed consent. -Main exclusion criteria: Local infection at the craniotomy site or active systemic infection. Presence of previous surgical instruments at the cranioplasty site. Need to use two or more implants for reconstruction. History of coagulopathies, uncontrolled diabetes mellitus or body mass index (BMI) greater than 35. Pregnant or lactating women. -Main variables: Efficacy and safety: frequency of complications such as infections, fractures and implant exposure. Cognitive functionality: Assessed by the Mini-Mental State Examination (MMSE). Functional independence: Measured with the Barthel index. Degree of disability: Assessed with the Modified Rankin Scale (mRS). Cosmetic satisfaction: Patient and surgeon satisfaction. Adverse events: Incidence during the 12 months of follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
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).
customized skull implants made of polyetheretheretherketone by three-dimensional printing in patients undergoing cranioplasty
Centro de Investigación Clínica y Medicina Traslacional (CIMET)
Guadalajara, Jalisco, Mexico
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.
Time frame: From enrollment to the end of treatment at 12 months
Infection at the implant site
Evaluate the frequency of infection at the implant site after cranioplasty.
Time frame: From enrollment to 3 months after surgery
Frequency of surgery-associated infections
These are infections that develop as a direct result of a surgical procedure. These infections can affect various parts of the body and are not necessarily limited to the implant site.
Time frame: From enrollment to 3 months after surgery
Frequency of implant exposure
It refers to the fact that the implants placed in the cranial region, in reconstructive or reparative surgeries of the skull, are visible or accessible in some way.
Time frame: From enrollment to the end of treatment at 12 months
Frequency and type of implant fractures
Refers to the rupture or cracking of devices implanted in the cranial region, used in reconstructive or reparative surgeries of the skull.
Time frame: From enrollment to the end of treatment at 12 months
Level of consciousness
Establish the level of consciousness with the Glasgow Coma Scale (GCS).
Time frame: From enrollment to 3 months after surgery
Cognitive function
Measure cognitive function with the Mini-Mental State Examination (MMSE).
Time frame: From enrollment to the end of treatment at 12 months
Functional independence
Evaluate functional independence with the Barthel Index.
Time frame: From enrollment to the end of treatment at 12 months
Level of disability
Evaluate the degree of disability with the modified Rankin Scale (mRS).
Time frame: From enrollment to the end of treatment at 12 months
Cosmetic satisfaction
Subjective scale to assess patient and surgeon satisfaction in terms of aesthetic and functional results after cranioplasty surgery.
Time frame: From enrollment to the end of treatment at 12 months
Frequency of adverse incidents
Time frame: From enrollment to the end of treatment at 12 months
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