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Evaluation of Cranial Flap Fixation With Montage Flowable Settable Bone Paste

NCT07103330 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-05

No results posted yet for this study

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

Interventions

DEVICE

Metallic fixation hardware

Control

DEVICE

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

Experimental

Sponsors & Collaborators

  • Abyrx, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07103330 on ClinicalTrials.gov