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

• Conditions: Ankle and Hindfoot Arthrodesis

• Registration Number: NCT02879149
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-25
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-23
• Last Update Posted: 2018-03-27
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (26)

Tucson Orthopedic Institute; 🇺🇸 Tucson, Arizona, United States

OrthoNorcal; 🇺🇸 Capitola, California, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Center for Bone and Joint Surgery; 🇺🇸 Royal Palm Beach, Florida, United States

Illinois Bone and Joint Institute, LLC; 🇺🇸 Glenview, Illinois, United States

MedStar Health Research Institute/ Union Memorial Hospital; 🇺🇸 Baltimore, Maryland, United States

Orthopaedic Associates of Michigan, PC; 🇺🇸 Grand Rapids, Michigan, United States

Michigan Orthopedic Center; 🇺🇸 Lansing, Michigan, United States

Desert Orthopaedics; 🇺🇸 Las Vegas, Nevada, United States

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