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.
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 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).
Parallel
Tetranite for Cranial Flap Fixation
Combination productTetranite for Cranial Flap Fixation is a bioresorbable bone adhesive that can be used to re-adhere the cranial flap following a craniotomy.
Standard of Care Plating System
DeviceThe standard of care titanium plates and screws will be used to re-adhere the cranial flap following a craniotomy.
Flap immobility at final surgical fixation (patient)
Immobility of the flap prior to surgical closure, assessed by the principal investigator and an independent neurosurgeon.
Flap immobility at 6 months (surgeon)
Flap immobility assessed through a flap mobility assessment by the principal investigator and an independent neurosurgeon.
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.
Flap immobility through 12 months (patient)
Flap immobility assessed by the patient through a survey.
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.
Adverse events, including CSF leaks or wound dehiscence
Adverse events, including CSF leaks or wound dehiscence
Patient reported outcome using PROMIS10
Survey sent to the patient to complete independently.
This trial is not recruiting at the moment. You can still explore other options:
