Recruiting

AUGMENT® vs. Autologous Bone GraftLong-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft

Sponsor:

BioMimetic Therapeutics

Code:

NCT02879149

Conditions

Ankle and Hindfoot Arthrodesis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AUGMENT® Bone Graft

Standard of Care

Study Details

Brief summary:

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

Conditions

Ankle and Hindfoot Arthrodesis

Study ID

NCT02879149

Start date

Aug, 2016

Status verified date

Mar, 2018

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

Standard Rigid Fixation plus autograft

Group 2

Standard rigid fixation plus AUGMENT® Bone Graft

Interventions

AUGMENT® Bone Graft

Standard of Care

Autologous Bone Graft

Primary outcome measure

Demonstration of bridging bone via CT [ Time Frame: Months 60 or greater ]
Subject function as determined by pain on weight bearing [ Time Frame: Months 60 or greater ]
Subject function as determined by AOFAS - AHS score [ Time Frame: Months 60 or greater ]
Subject function as determined by Foot Function Index [ Time Frame: Months 60 or greater ]

Central Contacts and Locations

Central contacts

Stephen Roach

615-656-7466 Stephen.Roach@wright.com

Locations

Tucson Orthopedic Institute

Recruiting

Tucson, Arizona, United States, 85712

Contacts

Jelena Candito

520-784-6446 jcandito@tucsonortho.com

Principal Investigator:

Nebojsa Skrepnik, MD

OrthoNorcal

Recruiting

Capitola, California, United States, 95010

Contacts

Clay Christensen

831-475-4024 cchristensen@orthonorcal.com

Principal Investigator:

Nicholas Abidi, MD

California Pacific Medical Center

Recruiting

San Francisco, California, United States, 94118

Contacts

Wilson Ling

415-600-3148 LingW@cpmcri.org

Principal Investigator:

Keith Donatto, M.D.

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Jamie Fish-Fuhrmann

860-972-5311 Jamie.fish-fuhrmann@hhchealth.org

Principal Investigator:

Raymond Sullivan, MD

Center for Bone and Joint Surgery

Recruiting

Royal Palm Beach, Florida, United States, 33411

Contacts

Samantha Levy

561-633-4241 samantha.levy@boneandjoint.org

Principal Investigator:

Robert Rochman, MD

Illinois Bone and Joint Institute, LLC

Recruiting

Glenview, Illinois, United States, 60025

Contacts

Steven Haddad, MD

847-998-5680 slhaddadmd@gmail.com

Principal Investigator:

Steven Haddad, MD

MedStar Health Research Institute/ Union Memorial Hospital

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Flossine Brown, BS, CRC

410-554-4451 flossine.brown@medstar.net

Principal Investigator:

Lew Schon, M.D.

Orthopaedic Associates of Michigan, PC

Recruiting

Grand Rapids, Michigan, United States, 49525

Contacts

Michelle Padley

616-459-7101 Michelle.Padley@oamichigan.com

Principal Investigator:

John Anderson, MD

Michigan Orthopedic Center

Recruiting

Lansing, Michigan, United States, 48910

Contacts

Wendy Downey

517-267-0200 Wdowney07@hotmail.com

Principal Investigator:

Michael Swords, MD

Desert Orthopaedics

Recruiting

Las Vegas, Nevada, United States, 89121

Contacts

Madison Hurley

702-731-1616 hurlem1@unlv.nevada.edu

Principal Investigator:

Troy Watson, MD

Rutgers New Jersey Medical School

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Melody Aldred, PhD

973-972-5435 Melody26@njms.rutgers.edu

Principal Investigator:

Sheldon Lin, M.D.

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Hayley McDermott

585-341-0556 Hayley_Mcdermott@URMC.Rochester.edu

Principal Investigator:

Judith Baumhauer, MD

OrthoCarolina

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Katherine Prassas

704-323-2266 Katherine.prassas@orthocarolina.com

Principal Investigator:

Robert Anderson, MD

Duke University Medical

Recruiting

Durham, North Carolina, United States

Contacts

Christina Van Sant

919-668-9175 christina.van.sant@duke.edu

Principal Investigator:

Mark Easley, M.D.

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Maxine Cox

216-444-5436 coxm@ccf.org

Principal Investigator:

Mark Berkowitz, M.D.

Orthopedic Foot and Ankle Center / OhioHealth Research Institute

Recruiting

Westerville, Ohio, United States, 43082

Contacts

Emily Stansbury

614-895-2424 stansburyet@orthofootankle.com

Principal Investigator:

Gregory Berlet, M.D.

The Center

Recruiting

Bend, Oregon, United States, 97701

Contacts

Meredith Dawson

541-382-2653 mdawson@thecenteroregon.com

Principal Investigator:

Tony Hinz, MD

Rothman Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Ioanna Kosmaoglou

267-339-3613 Ioanna.Kosmaoglou@rothmaninstitute.com

Principal Investigator:

Steven Raikin, MD

Campbell Clinic

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Marian Shaw

901-435-5705 mshaw@campbell-foundation.org

Principal Investigator:

Andrew Murphy, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Melyssa Fink

832-355-3710 Melyssa.Fink@bcm.edu

Principal Investigator:

William Granberry, MD

The Orthopaedic Foot & Ankle Center

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Nicole Patterson

703-584-2040 npatterson@footankledc.com

Principal Investigator:

Steven Neufeld, MD

Office of Orthopaedic Surgeons, Talisman Centre North Building

Recruiting

Calgary, Alberta, Canada, T2G 5B6

Contacts

Tara Heric

403-671-8645 jditara@yahoo.ca

Principal Investigator:

Ian Le, MD

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z-2A5

Contacts

Biraj Bora

604-806-8743 bbora@providencehealth.bc.ca

Principal Investigator:

Alastair Younger

QEll Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Contacts

Trish Francis, RN

902 473 5993 francisp@nsheath.ca

Principal Investigator:

Mark Glazebrook, MD

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5C 1R6

Contacts

Ryan Khan

416-864-6060 khanry@smh.ca

Principal Investigator:

Timothy Daniels, M.D.

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Antonietta Fazio

416-603-5800 afazio@uhnresearch.ca

Principal Investigator:

Johnny Lau, M.D.

More Information

Sponsor

BioMimetic Therapeutics

Last update posted

Mar 27, 2018

Last verified

Mar, 2018

Keywords

Ankle Fusions
AUGMENT® Bone Graft
Autologous Bone Graft
arthritis
ankle pain
foot pain
hindfoot fracture
ankle fracture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BioMimetic Therapeutics on 2018-03-27.