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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02879149
Recruitment Status : Unknown
Verified March 2018 by BioMimetic Therapeutics.
Recruitment status was:  Recruiting
First Posted : August 25, 2016
Last Update Posted : March 27, 2018
Information provided by (Responsible Party):
BioMimetic Therapeutics

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

Condition or disease Intervention/treatment
Ankle and Hindfoot Arthrodesis Device: AUGMENT® Bone Graft Procedure: Standard of Care

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : August 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

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

Primary Outcome Measures :
  1. Demonstration of bridging bone via CT [ Time Frame: Months 60 or greater ]
  2. Subject function as determined by pain on weight bearing [ Time Frame: Months 60 or greater ]
  3. Subject function as determined by AOFAS - AHS score [ Time Frame: Months 60 or greater ]
  4. Subject function as determined by Foot Function Index [ Time Frame: Months 60 or greater ]

Biospecimen Retention:   Samples Without DNA
Serum Samples for antibody testing.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02879149

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Contact: Stephen Roach 615-656-7466

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Sponsors and Collaborators
BioMimetic Therapeutics
Additional Information:
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Responsible Party: BioMimetic Therapeutics Identifier: NCT02879149    
Other Study ID Numbers: BMTI-2015-01
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by BioMimetic Therapeutics:
Ankle Fusions
AUGMENT® Bone Graft
Autologous Bone Graft
ankle pain
foot pain
hindfoot fracture
ankle fracture