This clinical pilot study will evaluate the use of a bioresorbable bone adhesive to improve cranial flap fixation at two study time points (at the time of fixation and 6 months). The aim of this Pilot Study is to demonstrate the safety and efficacy of the use of Tetranite for Cranial Flap Fixation (TN-CFF) to allow clinical study of the TN-CFF device in a greater number of patients.
The primary endpoint is safety during the post procedure follow up period. This endpoint will be evaluated through the rate of all serious adverse device and procedure related effects from the time of fixation to 6 months post-procedure. The secondary endpoints include efficacy evaluated through radiolucency data using CT imaging at the cranial flap cut lines and the change of radiolucency with respect to time, device related adverse events, flap immobility at time of fixation, six months and 12 months, evaluation of flap translation and patient reported outcome measures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Bioresorbable bone adhesive for cranial flap fixation following a craniotomy.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Semmes Murphey Clinic
Memphis, Tennessee, United States
The primary endpoint is the rate of all serious adverse device and procedure related effects during the post procedure follow up period.
Rate of all serious adverse device and procedure related effects from the time of fixation to 6 months post - procedure
Time frame: Time of fixation and 6 months post-procedure
Radiolucency data using CT imaging at the cranial flap cut lines.
Radiolucency data using CT imaging at the cranial flap cut lines and the change of radiolucency with respect to time.
Time frame: Throughout 12 Months post-procedure period
Change in radiolucency using CT imaging at the cranial flap cut lines with respect to time.
Radiolucency data using CT imaging at the cranial flap cut lines and the change of radiolucency with respect to time
Time frame: Throughout 12 Months post-procedure period
Device-related adverse events.
Device-related adverse events included all adverse events classified as definitely, probably, possibly, or undetermined relation to the device or procedure.
Time frame: Throughout 12 Months post-procedure period
Flap immobility determined clinical palpation of the cranial flap by an independent neurosurgeon.
Flap immobility will be determined by an independent neurosurgeon.
Time frame: Time of fixation and 6 months post-procedure
Flap immobility at 6 months and 12 months determined by clinical palpation of the cranial flap by the neurosurgeon and the patient.
Flap immobility will be determined by the surgeon and the patient.
Time frame: 6 months and 12 months post-procedure
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Translation of the flap based on CT scan.
Translation of the flap based on CT scan
Time frame: Throughout 12 Months post-procedure period
Patient Reported outcome using PROMIS10.
Subject satisfaction after TN-CFF was used for cranial flap fixation using a validated questionnaire for overall health.
Time frame: Throughout 12 Months post-procedure period
Patient Reported outcome using the 36 Item Short Form Survey (SF-36).
Subject satisfaction after TN-CFF was used for cranial flap fixation using a validated questionnaire for overall quality of life measures.
Time frame: Throughout 12 Months post-procedure period
Patient Reported outcome as measured on a Visual Analog Scale of pain intensity.
Subject satisfaction after TN-CFF is used for cranial flap fixation (i.e., level of headache pain)
Time frame: Throughout 12 Months post-procedure period