Clinical Trial

Evaluation of Cranial Flap Fixation With Montage Flowable Settable Bone Paste

Not Yet Recruiting
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Summary
Montage Flowable Settable Bone Paste is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25cm2. It is also intended to be used for the fixation of cranial bone flaps following craniotomy. The MONTAGE Flowable device comprises two separate components of paste-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together in the applicator tip, the components of the MONTAGE Flowable device form a cohesive paste-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate. The components must be mixed immediately prior to use.
Trial Details
NCT Number NCT07103330
Lead Sponsor Abyrx, Inc.
Conditions Cranial Bone, Post-operative Complications, Cranial Fixation, Cranioplasty, Adhesive Bone Cement
Enrollment 100 participants
Start Date 2026-03
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-08-05