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

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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
Rothman Institute
Philadelphia, Pennsylvania 19107
Principal Investigator: Steven Raikin, MD
Phone: 267-339-3613
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Philadelphia, PA
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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...
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Cleveland, OH
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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...
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Houston, TX
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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....
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Rochester, NY
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MedStar Health Research Institute at Union Memorial Hospital
Baltimore, Maryland 21218
Principal Investigator: Lew Schon, M.D.
Phone: 410-554-4451
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Baltimore, MD
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The Center
Bend, Oregon 97701
Principal Investigator: Tony Hinz, MD
Phone: 541-382-2653
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Bend, OR
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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
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Calgary,
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OrthoNorcal
4140 Jade Street
Capitola, California 95010
Principal Investigator: Nicholas Abidi, MD
Phone: 831-475-4024
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Capitola, CA
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OrthoCarolina
Charlotte, North Carolina 28207
Principal Investigator: Robert Anderson, MD
Phone: 704-323-2266
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Charlotte, NC
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Duke University Medical
Durham, North Carolina
Principal Investigator: Mark Easley, M.D.
Phone: 919-668-9175
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Durham, NC
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The Orthopaedic Foot & Ankle Center
2922 Telestar Court
Falls Church, Virginia 22042
Principal Investigator: Steven Neufeld, MD
Phone: 703-584-2040
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Falls Church, VA
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Campbell Clinic
Germantown, Tennessee 38138
Principal Investigator: Andrew Murphy, MD
Phone: 901-435-5705
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Germantown, TN
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Illinois Bone & Joint Institute
Glenview, Illinois 60025
Principal Investigator: Steven Haddad, MD
Phone: 847-998-5680
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Glenview, IL
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Orthopaedic Associates of Michigan
Grand Rapids, Michigan 49525
Principal Investigator: John Anderson, MD
Phone: 616-459-7101
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Grand Rapids, MI
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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...
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Hartford, CT
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Michigan Orthopedic Center
2815 South Pennsylvania Avenue
Lansing, Michigan 48910
Principal Investigator: Michael Swords, MD
Phone: 517-267-0200
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Lansing, MI
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Desert Orthopaedics
2800 East Desert Inn Road
Las Vegas, Nevada 89121
Principal Investigator: Troy Watson, MD
Phone: 702-731-1616
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Las Vegas, NV
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Rutgers New Jersey Medical School
Newark, New Jersey 07103
Principal Investigator: Sheldon Lin, M.D.
Phone: 973-972-5435
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Newark, NJ
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The Center for Bone and Joint Surgery
Royal Palm Beach, Florida 33411
Principal Investigator: Robert Rochman, MD
Phone: 561-633-4241
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Royal Palm Beach, FL
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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,...
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Tucson Orthopedic Institute, P.C.
5301 East Grant Road
Tucson, Arizona 85172
Principal Investigator: Nebojsa Skrepnik, MD
Phone: 520-784-6446
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Tucson, AZ
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Orthopedic Foot and Ankle Center / OhioHealth Research Institute
Westerville, Ohio 43082
Principal Investigator: Gregory Berlet, M.D.
Phone: 614-895-2424
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Westerville, OH
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