Actively Recruiting
A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive Based on Imaging and Patient Reported Outcomes
Led by RevBio · Updated on 2025-03-11
15
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a bioresorbable bone adhesive called Tetranite for improving cranial flap fixation in patients undergoing craniotomy. This pilot clinical study aims to demonstrate the safety and effectiveness of Tetranite compared to current metal fixation methods, with assessments at the time of fixation and after six months. The study focuses on safety outcomes and patient-reported results to support further clinical studies involving more patients. Participants will receive cranial flap fixation using either the standard metal plates and screws with Tetranite applied to fill kerf lines and burr holes, or Tetranite alone for flap fixation. The study includes two groups: the first five patients will have metal fixation plus Tetranite augmentation, followed by patients receiving only Tetranite. Treatments are delivered during surgery, with follow-up evaluations extending to twelve months. Participants will be monitored through clinical assessments including CT imaging to evaluate bone healing and flap position, clinical palpation to check flap immobility, and patient surveys measuring pain and quality of life. The primary safety outcome is the rate of serious device or procedure-related adverse effects within six months. Secondary measures include radiolucency changes, device-related events, flap translation, and patient-reported outcomes over a one-year period. The total participation time includes surgery and follow-up visits for up to twelve months.
CONDITIONS
Brief Title
A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Width of craniotomy kerf line < 3mm for more than 75% of the bone flap border (intra-operative inclusion)
You will not qualify if you...
- Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells (except if sealed)
- 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 (stereotactic biopsy not exclusionary)
- Subject requires a craniectomy (bone flap not replaced)
- Subject had radiation treatment to the surgical site or planned fractionated radiation therapy post-procedure (stereotactic radiosurgery prior not exclusionary)
- Subject requires a craniotomy across the sinus where Tetranite is applied adjacent to or within the sinus
- Subject has a condition with anticipated survival shorter than six months
- Subject has undergone chemotherapy (excluding hormonal therapy) within three weeks prior or planned within two weeks after the procedure or planned intracavitary chemotherapy wafer use
- Chronic steroid use daily for 8 weeks or more for non-chemotherapy reasons unless discontinued 4 weeks prior, or steroid toxicity
- Subject receives warfarin, heparin, or other anticoagulants daily without presurgical wash-out
- Subject is pregnant, breast-feeding, or intends to become pregnant during the study
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo cranial flap fixation using either metal fixation with Tetranite filler or Tetranite alone.
1 surgical visit (in-person)
Duration - 12 months post-procedure
Participants are monitored for safety and efficacy outcomes including flap immobility, radiolucency on CT imaging, flap translation, and patient-reported outcomes.
Visits at time of fixation, 6 months, and 12 months post-procedure with additional imaging assessments throughout 12 months
Trial Site Locations
Total: 1 location
1
Bristol Southmead Hospital
Bristol, United Kingdom, BS10 5NB
Actively Recruiting
Research Team
B
Brian Hess
S
Sarah Moss
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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