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Clinical Investigation of MONTAGE in Adults With Spinal Deformity Undergoing Pedicle Subtraction Osteotomy

NCT04125147 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-08-01

No results posted yet for this study

Summary

This study evaluates the difference in postoperative bleeding between two study groups, FDA cleared MONTAGE Settable Resorbable Hemostatic Bone Putty and standard of care (no bone hemostat) during pedicle subtraction osteotomy procedures.

Conditions

Interventions

DEVICE

Experimental: Montage Bone Hemostat

Use of Montage bone hemostat on the cut surfaces of bone at the osteotomy site

Sponsors & Collaborators

  • Abyrx, Inc.

    lead INDUSTRY

Principal Investigators

  • William Lavelle, MD · SUNY Upstate

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-05
Primary Completion
2023-07-20
Completion
2023-07-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04125147 on ClinicalTrials.gov