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Development of Bio Resorbable Cranial Implants for Neurosurgical Cranioplasty

Development of Bio Resorbable Cranial Implants for Neurosurgical Cranioplasty Procedure across Institutes of National Importance (INIs) - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089365
Enrollment
100
Registered
2025-06-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: S020- Fracture of vault of skull

Interventions

Intervention1: Cranioplasty Procedure: PCL Implants, Incision, bipolar device, Duration 2 year Intervention2: PMMA Cranioplasty: PMMA Mould implants

Sponsors

BIRAC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing cerebral surgeries that require a portion of skull to be cut out.

Exclusion criteria

Exclusion criteria: Patients having bone flaps stored in the abdomen which can be used for cranioplasty, pregnant women

Design outcomes

Primary

MeasureTime frame
The implants will eventually resorb within few months while the absorbed bone marrow aspirate will trigger repair of damaged blood vessels, revascularisation and finally regeneration of bony tissue. Total regeneration of the skull shall also be completed within the resorbing period. Timepoint: 18 Months & 2 weeks to 23 months 4 weeks—

Secondary

MeasureTime frame
The patient will experience a better quality of life than PMMA implants as there are least chances of infection or degradation. They’ll not require a re-cranioplasty of the defect. Timepoint: 18 month to 24 month—

Countries

India

Contacts

Public ContactDr Deepak Agrawal

All India Institute of Medical Sciences, New Delhi

drdeepak@gmail.com9811282043

Outcome results

None listed

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