Safety and Effectiveness of TETRANITE Bone Adhesive for Cranial Flap Fixation Compared to Traditi… (NCT07452549) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Effectiveness of TETRANITE Bone Adhesive for Cranial Flap Fixation Compared to Traditional Metal Hardware
204 participantsStarted 2026-04-15
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Flap immobility at final surgical fixation (patient)
Timeframe: At enrollment surgery
2
Flap immobility at 6 months (surgeon)
Timeframe: 6 months after index surgery
3
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.