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Clnical study of porous cranioplastic implant

Analysis of customized porous cranioplastic implant using biomaterials for cranial defect surgery

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20151118002
Enrollment
Unknown
Registered
2015-11-18
Start date
2009-04-01
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

Postoperative aesthetics&#44

Interventions

The scalp is opened and the circumferential edge of the cranial defects are identified. Each polyethylene implant is fixed to the cranium with 3 to 4 points using the titanium plates and screws.
Experimental Device
Cranioplasty

Sponsors

National Science and Technology Development Agency
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: - Patients who has skull defect resulted from any causes and has indication for cranial reconstruction.

Exclusion criteria

Exclusion criteria: - Patients who has skull infection within 1 year. - Patients who has the time between craniectomy and recruitment less than 3 months. - Patients who receive radiation therapy.

Design outcomes

Primary

MeasureTime frame
Performance of prefabricated implant as cranioplasty Intraoperative, Immediate, 2, 6, 12, 24 months post-operative Observation, Palpation, CT evaluation

Secondary

MeasureTime frame
Safety of implant Immediate, 2, 6, 12, 24 months post-operative Clinical evaluation

Countries

Thailand

Contacts

Public ContactPataravit Rukskul

Thammasat University

prukskul@yahoo.com6622926-9523

Outcome results

None listed

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