NCT07183540

Study on the Effect of Ultra-early Autologous Cranioplasty on Neurological Function Recovery

Study on the Effect of Ultra-early Autologous Cranioplasty on Neurological Function Recovery: a Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 582 (estimated)
• Sponsor: The Affiliated Hospital Of Guizhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To compare the neurological recovery and complication rate of autogenous cranioplasty(CP) within 6 weeks after decompressive craniectomy (DC) with that of autogenous cranioplasty within 3\~6 months after DC.

Detailed description

Objective: To compare the neurological recovery and complication rate of autogenous cranioplasty(CP) within 6 weeks after decompressive craniectomy (DC) with that of autogenous cranioplasty within 3\~6 months after DC. Design: This study is a multi-center, prospective, randomized controlled, open-label trial. Interventions: Intervention measures were the time point of cranioplasty: within 6 weeks after decompressive craniectomy VS 3-6 months after decompressive craniectomy.

Conditions

• Cranial Defect

Interventions

Type	Name	Description
PROCEDURE	operation opportunity-within 6 weeks after the DC operation.	The autologous skull repair surgery will be completed within 6 weeks after the DC operation.
PROCEDURE	operation opportunity-within 90 to 180 days after the DC operation.	The autologous skull repair surgery should be completed within 90 to 180 days after DC.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-09-19
• Last updated: 2025-09-19

Locations

7 sites across 1 country: China