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Clinical Study to evaluate clinical efficacy of patent specific cranial prothesis fabricated using 3-D Printed Model.

A study to evaluate the Clinical Efficacy of indigenously produced, 3D printed, patient specific acrylic cranial prosthesis in Decompressive Craniectomy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035575
Enrollment
10
Registered
2021-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 3D Printed patient specific Polymethyl methacrylate (PMMA) cranial prosthesis: Sample Size: 10, as there is no hypothesis to be tested, and since it is a feasibility and pilot study, th

Sponsors

Department of Biotechnology Government of India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients between the age of 18 and 70 years who have undergone decompressive craniectomy for trauma or stroke where autologous bone flap is not available for cranioplasty.

Exclusion criteria

Exclusion criteria: 1 Patient with a previous allergy to polymethyl methyacrylate. 2 Pregnant women and children.

Design outcomes

Primary

MeasureTime frame
Cranial index of symmetry, incidence of Infection and allergy, other complications.Timepoint: After Cranioplasty 1, 3, 6, 12 months.—

Secondary

MeasureTime frame
Neurological improvementTimepoint: After Cranioplasty 1, 3, 6, 12 months.;Patient health and other condition before and after the surgery.Timepoint: Patient will be evaluated for 12 months—

Countries

India

Contacts

Public ContactDr Quazi Syed Zahiruddin

JNMC, Datta Meghe Institute of Medical Sciences

zahirquazi@gmail.com9765404065

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026