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NOT YET RECRUITING
NCT07452549
NA

Safety and Effectiveness of TETRANITE Bone Adhesive for Cranial Flap Fixation Compared to Traditional Metal Hardware

Sponsor: RevBio

View on ClinicalTrials.gov

Summary

The aim of this study is to demonstrate the safety and efficacy of TETRANITE, a bioresorbable bone adhesive, for Cranial Flap Fixation as compared to traditional metal hardware.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2026-04-15

Completion Date

2027-12-15

Last Updated

2026-03-05

Healthy Volunteers

No

Conditions

Interventions

COMBINATION_PRODUCT

Tetranite for Cranial Flap Fixation

Tetranite for Cranial Flap Fixation is a bioresorbable bone adhesive that can be used to re-adhere the cranial flap following a craniotomy.

DEVICE

Standard of Care Plating System

The standard of care titanium plates and screws will be used to re-adhere the cranial flap following a craniotomy.