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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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