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

March 23, 2018 updated by: BioMimetic Therapeutics

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2G 5B6
        • Recruiting
        • Office of Orthopaedic Surgeons, Talisman Centre North Building
        • Contact:
        • Principal Investigator:
          • Ian Le, MD
        • Sub-Investigator:
          • Hugh Dougall, MD
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z-2A5
        • Recruiting
        • St. Paul's Hospital
        • Contact:
        • Principal Investigator:
          • Alastair Younger
        • Sub-Investigator:
          • Murray Penner
        • Sub-Investigator:
          • Kevin Wing
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Recruiting
        • QEll Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Mark Glazebrook, MD
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital
        • Contact:
        • Principal Investigator:
          • Johnny Lau, M.D.
      • Toronto, Ontario, Canada, M5C 1R6
        • Recruiting
        • St. Michael's Hospital
        • Contact:
        • Principal Investigator:
          • Timothy Daniels, M.D.
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • Tucson Orthopedic Institute
        • Contact:
        • Principal Investigator:
          • Nebojsa Skrepnik, MD
        • Sub-Investigator:
          • Eric Anctil, MD
    • California
      • Capitola, California, United States, 95010
        • Recruiting
        • OrthoNorcal
        • Contact:
        • Principal Investigator:
          • Nicholas Abidi, MD
      • San Francisco, California, United States, 94118
        • Recruiting
        • California Pacific Medical Center
        • Contact:
        • Principal Investigator:
          • Keith Donatto, M.D.
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Hospital
        • Contact:
        • Principal Investigator:
          • Raymond Sullivan, MD
        • Sub-Investigator:
          • Ross Benthien, MD
    • Florida
      • Royal Palm Beach, Florida, United States, 33411
        • Recruiting
        • Center for Bone and Joint Surgery
        • Contact:
        • Principal Investigator:
          • Robert Rochman, MD
    • Illinois
      • Glenview, Illinois, United States, 60025
        • Recruiting
        • Illinois Bone and Joint Institute, LLC
        • Contact:
        • Principal Investigator:
          • Steven Haddad, MD
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • MedStar Health Research Institute/ Union Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Lew Schon, M.D.
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Recruiting
        • Orthopaedic Associates of Michigan, PC
        • Contact:
        • Principal Investigator:
          • John Anderson, MD
      • Lansing, Michigan, United States, 48910
        • Recruiting
        • Michigan Orthopedic Center
        • Contact:
        • Principal Investigator:
          • Michael Swords, MD
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Recruiting
        • Desert Orthopaedics
        • Contact:
        • Principal Investigator:
          • Troy Watson, MD
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Recruiting
        • Rutgers New Jersey Medical School
        • Contact:
        • Principal Investigator:
          • Sheldon Lin, M.D.
    • New York
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
        • Principal Investigator:
          • Judith Baumhauer, MD
        • Sub-Investigator:
          • A.S Flemister, MD
        • Sub-Investigator:
          • Jordan Evanicki, PA
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Recruiting
        • OrthoCarolina
        • Contact:
        • Principal Investigator:
          • Robert Anderson, MD
        • Sub-Investigator:
          • Bruce Cohen, MD
        • Sub-Investigator:
          • William Davis, MD
        • Sub-Investigator:
          • Carroll Jones, MD
      • Durham, North Carolina, United States
        • Recruiting
        • Duke University Medical
        • Contact:
        • Principal Investigator:
          • Mark Easley, M.D.
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Mark Berkowitz, M.D.
        • Sub-Investigator:
          • Sara Miniaci-Coxhead, M.D.
        • Sub-Investigator:
          • Michael Tompkins, M.D.
        • Sub-Investigator:
          • Alan Davis, M.D.
      • Westerville, Ohio, United States, 43082
        • Recruiting
        • Orthopedic Foot and Ankle Center / OhioHealth Research Institute
        • Contact:
        • Principal Investigator:
          • Gregory Berlet, M.D.
    • Oregon
      • Bend, Oregon, United States, 97701
        • Recruiting
        • The Center
        • Contact:
        • Principal Investigator:
          • Tony Hinz, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • Campbell Clinic
        • Contact:
        • Principal Investigator:
          • Andrew Murphy, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
        • Principal Investigator:
          • William Granberry, MD
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • The Orthopaedic Foot & Ankle Center
        • Contact:
        • Principal Investigator:
          • Steven Neufeld, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and female subjects over the age of 18 years of age, who were randomized and treated as part of the population of the BMTI-2006-01 protocol.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Standard Rigid Fixation plus autograft
Procedure: Standard of Care
Autologous Bone Graft
Group 2
Standard rigid fixation plus AUGMENT® Bone Graft
Device: AUGMENT® Bone Graft
AUGMENT® Bone Graft

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioMimetic Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

August 17, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Actual)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 23, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BMTI-2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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