A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive
ConditionCraniotomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRevBio
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Sequential
Treatments tested in this trial
Tetranite for Cranial Flap Fixation (TN-CFF)
DeviceBioresorbable bone adhesive for cranial flap fixation following a craniotomy.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: Hardware AugmentationExperimental treatment 1 intervention
Group B: StandaloneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
Flap immobility as 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.Other outcomes
1
Neurological Exam using the Karnofsky Performance Scale (KPS)
Neurological exam will be completed throughout the study to assess neurological healing. The KPS scale is designed to measure the level of patient activity and medical care requirements
Time frame
Throughout 12 Months post-procedure period.2
Neurological Exam using the Neurologic Assessment in Neuro-Oncology (NANO) scale.
Neurological exams will be completed throughout the study to assess neurological healing. The NANO scale is a quantifiable evaluation of 9 relevant neurologic domains based on direct observation and testing conducted during routine office visits.
Time frame
Throughout 12 Months post-procedure period.3
Wound Healing
Wound healing will be evaluated at post-surgical visits and will result in one of the three results: Surgical Revision needed, Superficial dehiscence, Completely Healed
Time frame
Throughout 12 Months post-procedure period4
Patient reported outcomes will also be measured using a patient taken picture of surgical wound.
A patient taken picture of surgical wound will be taken to show wound progress.
Time frame
Throughout 12 Months post-procedure period. Source ClinicalTrials.gov