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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Metallic fixation hardware
DeviceControl
Cranial flap placement and fixation using only Montage Flowable Settable Bone Paste
DeviceExperimental
Treatment groups
Trial outcomes
Primary outcomes
Cranial flap immobility
Cranial flap immobility as determine by the neurosurgeon will be tabulated and compared between group
Secondary outcomes
Flap localization
Localization of the flap based on CT scan compared between groups.
Device-related adverse events
• Device related adverse events included all adverse events classified as definitely, probably, possibly, or undetermined relation to the device or procedure
Other outcomes
Complications
Complication categories will also be tabulated and compared
Locations
Sponsors and contacts
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