Evaluation of Cranial Flap Fixation With Montage Flowable Settable Bone Paste

NCT07103330 | Not Yet Recruiting FDA Device

• 1 other identifier: Abyrx PMRCT 25-001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cranial Bone; Post-operative Complications; Cranial Fixation; Cranioplasty; Adhesive Bone Cement

Keywords

Cranioplasty; Settable bone paste; Adhesive cranial cement

Outcome Measures

Primary Outcomes (1)

• Cranial flap immobility

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

  12 months

Secondary Outcomes (2)

• Flap localization

  12 months

• Device-related adverse events

  12 months

Other Outcomes (1)

• Complications

  12 months

Study Arms (2)

Montage Flowable Settable Bone Paste

EXPERIMENTAL

Fixation using Montage Flowable Settable Bone Paste exclusively

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

Control

ACTIVE COMPARATOR

Metallic fixation hardware

Device: Metallic fixation hardware

Interventions

Metallic fixation hardware DEVICE

Control

Control

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

Experimental

Montage Flowable Settable Bone Paste

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 requires a craniectomy (the bone flap is not replaced during the current surgery).
• Subject requires a craniotomy across the sinus for which Montage Flowable is applied adjacent to or within the sinus to fixate the cranial flap.
• Subject has a condition with anticipated survival shorter than six months.
• Subject has undergone chemotherapy treatment, excluding hormonal therapy, within three weeks prior to the planned index procedure, or use of intracavitary chemotherapy wafer (BCNU) was planned, or chemotherapy treatment was planned within two weeks after the index procedure was performed.
• Subject receives warfarin, heparin, other anticoagulant agents on a daily basis and pre-surgical, standard of care drug wash-out did not occur.
• Subject is pregnant, breast-feeding, or intended to become pregnant during the course of the study.

Sponsors & Collaborators

• Abyrx, Inc.: lead

Central Study Contacts

Aniq Darr, Ph.D.

CONTACT

18554759175; Darr@Abyrx.com

Alyssa McDermott, M.S.

CONTACT

8554759175; McDermott@Abyrx.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Post-market, Prospective, Randomized, Multi Center, Single Blind (Patient)

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share