FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20211026003
Enrollment
66
Registered
2021-10-26
Start date
2021-10-26
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Patients who were implanted with the tailor-made titanium cranioplasty implant produced by 3D printing technique for 30 samples in 4 sites.,Patients who were implanted with the intra-operative PMMA cr
Device Feasibility,Device Feasibility,Device Feasibility
Sample group 1,Sample group 2,Sample group 3

Sponsors

Health System Research Institute (HSRI)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

Thailand

Contacts

Public ContactThanakorn Thiensri

Phramongkutklao hospital

thanakorn.aof1@gmail.com0991988988

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026