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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Craniotomy
• Intervention / Treatment: Combination product: Tetranite for Cranial Flap Fixation; Device: Standard of Care Plating System

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.

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Moss; Phone Number: 281-795-1812; Email: smoss@primepathmedtech.com
• Study Contact Backup: Name: Gracie Cleaver; Phone Number: 862-202-3109; Email: gcleaver@revbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Intra-Operative Inclusion Criteria:

• Width of craniotomy kerf line < 3mm for more than 75% of the bone flap border.

Exclusion Criteria:

• Subject has undergone a previous, open intracranial neurosurgical procedure in the same anatomical location. (Note: stereotactic biopsy is not exclusionary).

  • Subject requires a craniectomy (the bone flap is not replaced during the current surgery).
  • Subject has had radiation treatment to the surgical site within the past year, or standard fractionated radiation therapy was planned within 2 weeks post index-procedure. (Note: stereotactic radiosurgery prior to the planned index procedure was not an exclusion criterion.)
  • Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells. Note: Superficial penetration of mastoid air cells is not an exclusion if cells were appropriately sealed (e.g., bone wax).
  • 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.
  • Standard use of peri-operative steroids (i.e., corticosteroids) is permitted. Chronic steroid use (defined as daily use of corticosteroids for ≥ 8 weeks) for the purposes of reducing the side effects of chemotherapy and/or radiation therapy for cancer is not exclusionary unless the patient is deemed by the investigator to be suffering from steroid toxicity (i.e., Cushing's syndrome) manifested by symptoms and signs such as thin skin, striae, easy bruising, muscle atrophy, upper body obesity, severe fatigue, etc. Use of corticosteroids on a chronic basis (as defined previously) for purposes other than decreasing the symptoms of systemic chemotherapy is exclusionary unless those steroids were discontinued 4 weeks prior to the planned index procedure.
  • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TETRANITE Bone Adhesive; These participants will receive tetranite to re-adhere the cranial flap following a craniotomy.	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.
Active Comparator: Standard of Care Plating System; 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; The standard of care titanium plates and screws will be used to re-adhere the cranial flap following a craniotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flap immobility through 12 months (patient)	Flap immobility assessed by the patient through a survey.	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.	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	Adverse events, including CSF leaks or wound dehiscence	From enrollment through 12 months after index surgery.
Patient reported outcome using PROMIS10	Survey sent to the patient to complete independently.	Enrollment through 12 months from index surgery.
Patient reported outcome using VAS Pain Score	Survey sent to the patient to complete independently.	Enrollment through 12 months from index surgery
Patient reported outcome using Cranio-Facial PROMS	Survey sent to the patient to complete independently.	Enrollment through 12 months from index surgery
Flap volume change to assess growth/atrophy based on CT at 6 and 12 Months	Flap volume change to assess growth/atrophy based on CT at 6 and 12 Months	6 months and 12 months
Flap fusion to assess bony bridging of the kerf and burr holes via kerf and burr hole gap volume increase/decrease based on CT at 6 and 12 Months	Flap fusion to assess bony bridging of the kerf and burr holes via kerf and burr hole gap volume increase/decrease based on CT at 6 and 12 Months	6 months and 12 months
Flap congruence to assess immediate post-operative conformance to surrounding bone	Flap congruence to assess immediate post-operative conformance to surrounding bone	1-4 days from index surgery (+7/-3)
Flap displacement to assess migration via peak displacement of the flap surface based on CT at 6 and 12 Months compared to post-operative placement	Flap displacement to assess migration via peak displacement of the flap surface based on CT at 6 and 12 Months compared to post-operative placement	6 months and 12 months
Artifact assessment of distortion that obscures lesion detection based on available standard of care MRI throughout the 12- month study period	Artifact assessment of distortion that obscures lesion detection based on available standard of care MRI throughout the 12- month study period	From enrollment through 12 months following index procedure

Collaborators and Investigators

• Sponsor: RevBio

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): December 15, 2027

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: DVAL25068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes