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

Ankle and Hindfoot Arthrodesis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02879149
• Other study ID #: BMTI-2015-01
• Status: Recruiting
• First received: August 17, 2016
• Last updated: March 23, 2018
• Start date: August 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2018
• Source: BioMimetic Therapeutics
• Contact: Stephen Roach
• Phone: 615-656-7466
• Email: Stephen.Roach[@]wright.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankle and Hindfoot Arthrodesis

Intervention

Device:
• AUGMENT® Bone Graft
AUGMENT® Bone Graft

Procedure:
• Standard of Care
Autologous Bone Graft

Locations

Country	Name	City	State
Canada	Office of Orthopaedic Surgeons, Talisman Centre North Building	Calgary	Alberta
Canada	QEll Health Sciences Centre	Halifax	Nova Scotia
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
United States	MedStar Health Research Institute/ Union Memorial Hospital	Baltimore	Maryland
United States	The Center	Bend	Oregon
United States	OrthoNorcal	Capitola	California
United States	OrthoCarolina	Charlotte	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical	Durham	North Carolina
United States	The Orthopaedic Foot & Ankle Center	Falls Church	Virginia
United States	Campbell Clinic	Germantown	Tennessee
United States	Illinois Bone and Joint Institute, LLC	Glenview	Illinois
United States	Orthopaedic Associates of Michigan, PC	Grand Rapids	Michigan
United States	Hartford Hospital	Hartford	Connecticut
United States	Baylor College of Medicine	Houston	Texas
United States	Michigan Orthopedic Center	Lansing	Michigan
United States	Desert Orthopaedics	Las Vegas	Nevada
United States	Rutgers New Jersey Medical School	Newark	New Jersey
United States	Rothman Institute	Philadelphia	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	Center for Bone and Joint Surgery	Royal Palm Beach	Florida
United States	California Pacific Medical Center	San Francisco	California
United States	Tucson Orthopedic Institute	Tucson	Arizona
United States	Orthopedic Foot and Ankle Center / OhioHealth Research Institute	Westerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
BioMimetic Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstration of bridging bone via CT		Months 60 or greater
Primary	Subject function as determined by pain on weight bearing		Months 60 or greater
Primary	Subject function as determined by AOFAS - AHS score		Months 60 or greater
Primary	Subject function as determined by Foot Function Index		Months 60 or greater

External Links

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