Multicenter retrospective data collection and prospective follow-up of patients who were implanted with the tailor-made titanium cranioplasty implant produced by 3D printing technique and intra-operative PMMA cranioplasty implant

• Conditions: Patients who were implanted with the tailor-made titanium cranioplasty implant produced by 3D printing technique or the intra-operative cranioplasty plate for 6 months or over.; Cranioplasty; Tailor-made titanium cranioplasty plate; Intra-operative cranioplasty plate; Infection rate; Quality of life

• Registration Number: TCTR20211026003
• Lead Sponsor: Health System Research Institute (HSRI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-26
• Study Completion: 2022-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Patients who were implanted with the tailor-made titanium cranioplasty implant produced by 3D printing technique or the intra-operative cranioplasty plate from 1 January 2019 - 28 February 2021 in 4 medical sites, Phramongkutklao hospital, Maharaj Nakorn Chiang Mai hospital, Taksin hospital, and Prasat Neurological Institute.

Exclusion Criteria

Patients who have no follow-up data for 6 months.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infection rate 6 months after cranioplasty surgery Descriptive statistics,Complication rate and cause 6 months after cranioplasty surgery Descriptive statistics,Surgical operation time Intra-operative time (skin to skin) Descriptive statistics

Secondary Outcome Measures

Name	Time	Method
Patient quality of life 6 months after cranioplasty surgery Qualitative research discussion,Comparative economic value between tailor-made titanium cranioplasty plate and intra-operative PMM cranioplasty plate in direct medical and non-medical cost 6 months after cranioplasty surgery Qualitative research discussion,Comparative budget impact and social impact between tailor-made titanium cranioplasty plate and intra-operative PMM cranioplasty plate 6 months after cranioplasty surgery Qualitative research discussion