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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Metallic fixation hardware

    Device

    Control

  • Cranial flap placement and fixation using only Montage Flowable Settable Bone Paste

    Device

    Experimental

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Montage Flowable Settable Bone PasteExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cranial flap immobility

Cranial flap immobility as determine by the neurosurgeon will be tabulated and compared between group

Time frame
12 months

Secondary outcomes

1

Flap localization

Localization of the flap based on CT scan compared between groups.

Time frame
12 months
2

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

Time frame
12 months

Other outcomes

1

Complications

Complication categories will also be tabulated and compared

Time frame
12 months

Locations

This trial has no locations.

Sponsors and contacts

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