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

NCT07452549 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: DVAL25068
• Study Type: interventional
• Target: 204
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Craniotomy

Outcome Measures

Primary Outcomes (3)

• Flap immobility at final surgical fixation (patient)

  Immobility of the flap prior to surgical closure, assessed by the principal investigator and an independent neurosurgeon.

  At enrollment surgery

• Flap immobility at 6 months (surgeon)

  Flap immobility assessed through a flap mobility assessment by the principal investigator and an independent neurosurgeon.

  6 months after index surgery

• No incidence of serious adverse events, including unplanned retreatment of the original surgical site, adjudicated by the CEC to be device-related within 6 months of index surgery.

  No incidence of serious adverse events, including unplanned retreatment of the original surgical site, adjudicated by the CEC to be device-related within 6 months of index surgery.

  6 months from enrollment

Secondary Outcomes (11)

• Flap immobility through 12 months (patient)

  12 months

• Serious adverse events, including unplanned retreatment of the original surgical site, adjudicated by the CEC to be device-related beyond 6 months of index surgery.

  6 months from enrollment to 12 months

• Adverse events, including CSF leaks or wound dehiscence

  From enrollment through 12 months after index surgery.

• Patient reported outcome using PROMIS10

  Enrollment through 12 months from index surgery.

• Patient reported outcome using VAS Pain Score

  Enrollment through 12 months from index surgery

Study Arms (2)

TETRANITE Bone Adhesive

EXPERIMENTAL

These participants will receive tetranite to re-adhere the cranial flap following a craniotomy.

Combination Product: Tetranite for Cranial Flap Fixation

Standard of Care Plating System

ACTIVE COMPARATOR

These participants will receive the standard of care plating system to re-adhere the cranial flap following a craniotomy.

Device: Standard of Care Plating System

Interventions

Tetranite for Cranial Flap Fixation COMBINATION_PRODUCT

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

TETRANITE Bone Adhesive

Standard of Care Plating System DEVICE

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

Standard of Care Plating System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject, and/or subject's family are able and willing to provide informed consent and HIPAA authorization prior to any study related procedures.
• Subjects can be any gender, but be between (and including) 18 and 80 years of age
• Subject is scheduled for a cranial procedure that requires the creation of a bone flap or replacement of a bone flap (i.e., cranioplasty)
• Subject is scheduled for a cranial procedure in the supratentorial location.
• Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.
• Pre-operative CT scan for craniotomy patients must be less than or equal to 0.625 mm slice thickness and pixel spacing. It shall include the skull in native condition near the planned flap site DICOM export must be thin sliced reconstruction in the bone window.
• Width of craniotomy kerf line \< 3mm for more than 75% of the bone flap border.

You may not qualify if:

• Subject requires a craniectomy (the bone flap is not replaced during the current surgery).
• Subject has clinically significant hydrocephalus or clinical evidence of altered CSF dynamics. Subject has undergone chemotherapy treatment, excluding hormonal therapy, within three weeks prior to the planned index procedure, or use of intracavitary chemotherapy wafer (BCNU) was planned, or chemotherapy treatment was planned within two weeks after the index procedure was performed.
• Subject has a condition with anticipated survival shorter than one year.
• Subject receives warfarin, heparin, other anticoagulant agents on a daily basis and pre-surgical, standard of care drug wash-out did not occur.
• Subject is pregnant, breast-feeding, or intended to become pregnant during the course of the study.
• Current infection (either superficial or deep) at the planned operative site
• Sepsis diagnosed within one week before the planned index procedure

Sponsors & Collaborators

• RevBio: lead

Central Study Contacts

Gracie Cleaver

CONTACT

862-202-3109; gcleaver@revbio.com

Sarah Moss

CONTACT

281-795-1812; smoss@primepathmedtech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 5, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share