Evaluation of Cranial Flap Fixation With Montage Flowable Settable Bone Paste
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbyrx, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Male or female > 18 years of age
Undergoing a cranial procedure in supratentorial location
Width of craniotomy kerf line <3mm for than 75% of the bone flap border
Disqualifiers
Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells.
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
Treatments tested in this trial
- Metallic fixation hardware
- Cranial flap placement and fixation using only Montage Flowable Settable Bone Paste
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov