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.
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