NCT07452549

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: RevBio · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This two arm study will assess the safety and efficacy of TETRANITE, a bioresorbable bone adhesive, for Cranial Flap Fixation as compared to traditional metal hardware. The control arm for this study is the standard of care plating system. Participants will be randomly assigned to either the TETRANITE arm, or the standard of care plating system arm. Participants will generally follow their standard of care follow-up for surgery for one year.

Conditions

• Craniotomy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-15
• Primary completion: 2027-06-15
• Completion: 2027-12-15
• First posted: 2026-03-05
• Last updated: 2026-03-05

Regulatory

• FDA-regulated device study