New bone glue could replace metal screws in skull surgery
NCT ID NCT06095531
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests a new bioresorbable bone adhesive (Tetranite) to fix skull bone flaps after cranial surgery in 20 adults. The goal is to see if the glue is safe and works well, using CT scans and patient reports over 6 months. If successful, it may lead to larger studies and offer an alternative to metal plates or screws.
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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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Jun 2026
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 75 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: * Subjects or representatives must have voluntarily signed the informed consent form before any study related procedures. * Subjects can be any gender, but be between (and including) 18 and 75 years of age * Subject is scheduled for a cranial procedure in the supratentorial location. * Subject requires a procedure involving a Class I/clean wound (uninfected surgical wound in which no inflammation was encountered). * Subject, and/or subject's family are able and willing to provide informed consent and HIPAA authorization. * Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests. Intra-Operative Inclusion Criteria: * Width of craniotomy kerf line \< 3mm for more than 75% of the bone flap border Exclusion Criteria: * 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 a previous, open intracranial neurosurgical procedure in the same anatomical location. (Note: stereotactic biopsy was not exclusionary). * Subject requires a craniectomy (the bone flap is not replaced during the current surgery). * Subject had radiation treatment to the surgical site, or standard fractionated radiation therapy was planned post index-procedure. (Note: stereotactic radiosurgery prior to the planned index procedure was not an exclusion criterion.) * Subject has a condition with anticipated survival shorter than six months. * 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 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Semmes Murphey Clinic
Memphis, Tennessee, 38120, United States
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