Pilot Study - Cranial Flap Fixation with Tetranite
Research type
Research Study
Full title
A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation with a Bioresorbable Bone Adhesive based on Imaging and Patient Reported Outcomes
IRAS ID
322033
Contact name
Brian Hess
Contact email
Sponsor organisation
RevBio, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The purpose of the present study is to evaluate the use of a bioresorbable bone adhesive (Tetranite® for Cranial Flap Fixation Material (TN-CFF) to improve cranial flap fixation at two study time points (at the time of fixation and 6 months). The objectives of this study is to show evidence of adequate cranial flap fixation with TN-CFF based on imaging and patient reported outcomes and to demonstrate the safety and efficacy of the use of TN-CFF to allow for further clinical studies. In addition to the Primary Endpoints of flap immobility at the time of flap fixation and at 6 months post surgery, the study also assesses several secondary endpoints over the course of the study and one-year follow-up, as outlined in the sections below. These include assessment of incidence, duration, and severity of adverse effects and events; radiolucency (bone growth) of the cranial flap cut lines over time; translation of the flap; patient satisfaction surveys; patient taken pictures; and assessment of overall health using a focused neurological exam and wound healing assessment.
REC name
Wales REC 7
REC reference
23/WA/0259
Date of REC Opinion
1 Nov 2023
REC opinion
Further Information Favourable Opinion