Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:August 2016
End Date:December 2018
Contact:Stephen Roach
Email:Stephen.Roach@wright.com
Phone:615-656-7466

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

A Prospective, Controlled, Multi-Center, Post-Approval Trial to Evaluate the Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions

The objective of this long-term study is to evaluate the long term effectiveness and safety
of AUGMENT® Bone Graft vs. autologous bone graft. The study involves evaluation of subjects
originally treated under Protocol BMTI-2006-01.

Subjects will be asked to consent and return to provide long-term follow-up data at or after
60 months (5 years) have elapsed since their original surgery as a subject in protocol
BMTI-2006-01.

STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® Bone Graft is maintained
and remains comparable to that of autologous bone graft over long-term subject follow-up.

REGULATORY PHASE: Post-approval study


Inclusion Criteria:

Subjects who meet the following criteria may be included in the study:

1. Must be willing and able to provide informed consent and be available for the planned
follow-up evaluations and radiologic tests; and

2. Must have been randomized, treated and included in the safety population of Protocol
BMTI-2006-01 (see Exhibit 13.1).

Exclusion Criteria:

1) Subjects that were excluded from the safety analysis in the BMTI-2006-01 study (subjects
not listed in Exhibit 13.1). These subjects were consented, but never treated as part of
the BMTI-2006-01 protocol.
We found this trial at
22
sites
Cleveland Clinic
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Mark Berkowitz, M.D.
Phone: 216-444-5436
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
2035
mi
from 91732
Cleveland, OH
Click here to add this to my saved trials
Baylor College of Medicine
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: William Granberry, MD
Phone: 832-355-3710
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
University of Rochester
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Judith Baumhauer, MD
Phone: 585-341-0556
University of Rochester The University of Rochester is one of the country's top-tier research universities....
2244
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
MedStar Health Research Institute at Union Memorial Hospital
Baltimore, Maryland 21218
Principal Investigator: Lew Schon, M.D.
Phone: 410-554-4451
2301
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
The Center
Bend, Oregon 97701
Principal Investigator: Tony Hinz, MD
Phone: 541-382-2653
712
mi
from 91732
Bend, OR
Click here to add this to my saved trials
Office of Orthopaedic Surgeons, Talisman Centre North Building
2225 Macleod Trail Southeast
Calgary, Alberta T2G 5B6
Principal Investigator: Ian Le, MD
Phone: 403-671-8645
1188
mi
from 91732
Calgary,
Click here to add this to my saved trials
OrthoNorcal
4140 Jade Street
Capitola, California 95010
Principal Investigator: Nicholas Abidi, MD
Phone: 831-475-4024
298
mi
from 91732
Capitola, CA
Click here to add this to my saved trials
OrthoCarolina
Charlotte, North Carolina 28207
Principal Investigator: Robert Anderson, MD
Phone: 704-323-2266
2102
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
Duke University Medical
Durham, North Carolina
Principal Investigator: Mark Easley, M.D.
Phone: 919-668-9175
2201
mi
from 91732
Durham, NC
Click here to add this to my saved trials
The Orthopaedic Foot & Ankle Center
2922 Telestar Court
Falls Church, Virginia 22042
Principal Investigator: Steven Neufeld, MD
Phone: 703-584-2040
2271
mi
from 91732
Falls Church, VA
Click here to add this to my saved trials
Campbell Clinic
Germantown, Tennessee 38138
Principal Investigator: Andrew Murphy, MD
Phone: 901-435-5705
1600
mi
from 91732
Germantown, TN
Click here to add this to my saved trials
Illinois Bone & Joint Institute
Glenview, Illinois 60025
Principal Investigator: Steven Haddad, MD
Phone: 847-998-5680
1722
mi
from 91732
Glenview, IL
Click here to add this to my saved trials
Orthopaedic Associates of Michigan
Grand Rapids, Michigan 49525
Principal Investigator: John Anderson, MD
Phone: 616-459-7101
1843
mi
from 91732
Grand Rapids, MI
Click here to add this to my saved trials
The Hartford Hospital
80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
Principal Investigator: Raymond Sullivan, MD
Phone: 860-972-5311
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
2497
mi
from 91732
Hartford, CT
Click here to add this to my saved trials
Michigan Orthopedic Center
2815 South Pennsylvania Avenue
Lansing, Michigan 48910
Principal Investigator: Michael Swords, MD
Phone: 517-267-0200
1894
mi
from 91732
Lansing, MI
Click here to add this to my saved trials
Desert Orthopaedics
2800 East Desert Inn Road
Las Vegas, Nevada 89121
Principal Investigator: Troy Watson, MD
Phone: 702-731-1616
217
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
Rutgers New Jersey Medical School
Newark, New Jersey 07103
Principal Investigator: Sheldon Lin, M.D.
Phone: 973-972-5435
2422
mi
from 91732
Newark, NJ
Click here to add this to my saved trials
Rothman Institute
Philadelphia, Pennsylvania 19107
Principal Investigator: Steven Raikin, MD
Phone: 267-339-3613
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
The Center for Bone and Joint Surgery
Royal Palm Beach, Florida 33411
Principal Investigator: Robert Rochman, MD
Phone: 561-633-4241
2295
mi
from 91732
Royal Palm Beach, FL
Click here to add this to my saved trials
California Pacific Medical Center
45 Castro Street
San Francisco, California 94114
(415) 600-6000
Principal Investigator: Keith Donatto, M.D.
Phone: 415-600-3148
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
356
mi
from 91732
San Francisco, CA
Click here to add this to my saved trials
Tucson Orthopedic Institute, P.C.
5301 East Grant Road
Tucson, Arizona 85172
Principal Investigator: Nebojsa Skrepnik, MD
Phone: 520-784-6446
431
mi
from 91732
Tucson, AZ
Click here to add this to my saved trials
Orthopedic Foot and Ankle Center / OhioHealth Research Institute
Westerville, Ohio 43082
Principal Investigator: Gregory Berlet, M.D.
Phone: 614-895-2424
1964
mi
from 91732
Westerville, OH
Click here to add this to my saved trials