Bone glue could replace metal screws in skull surgery
NCT ID NCT07452549
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new bioresorbable bone adhesive called TETRANITE for fixing bone flaps in the skull after surgery, comparing it to standard metal hardware. About 204 adults aged 18-80 who need a cranial procedure will be enrolled. The goal is to see if the glue is safe and keeps the bone flap stable.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 204 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
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How to take part
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The official record
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A doctor treating you
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