Pilot Study Evaluating Safety and Effectiveness of Bioresorbable Bone Adhesive for Cranial Flap Fixation After Craniotomy

What this Trial Is About

Researchers are evaluating the use of a bioresorbable bone adhesive called Tetranite for improving cranial flap fixation in patients undergoing craniotomy. This pilot clinical study aims to demonstrate the safety and effectiveness of Tetranite compared to current metal fixation methods, with assessments at the time of fixation and after six months. The study focuses on safety outcomes and patient-reported results to support further clinical studies involving more patients. Participants will receive cranial flap fixation using either the standard metal plates and screws with Tetranite applied to fill kerf lines and burr holes, or Tetranite alone for flap fixation. The study includes two groups the first five patients will have metal fixation plus Tetranite augmentation, followed by patients receiving only Tetranite. Treatments are delivered during surgery, with follow-up evaluations extending to twelve months. Participants will be monitored through clinical assessments including CT imaging to evaluate bone healing and flap position, clinical palpation to check flap immobility, and patient surveys measuring pain and quality of life. The primary safety outcome is the rate of serious device or procedure-related adverse effects within six months. Secondary measures include radiolucency changes, device-related events, flap translation, and patient-reported outcomes over a one-year period. The total participation time includes surgery and follow-up visits for up to twelve months.

A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive