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

BioMimetic Therapeutics150 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

150

Conditions

Ankle and Hindfoot Arthrodesis

Interventions

AUGMENT® Bone GraftDEVICE

AUGMENT® Bone Graft

Autologous Bone Graft

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (26)

Tucson Orthopedic Institute

Tucson, Arizona, United States

RECRUITING

OrthoNorcal

Capitola, California, United States

RECRUITING

California Pacific Medical Center

San Francisco, California, United States

RECRUITING

Hartford Hospital

Hartford, Connecticut, United States

Outcomes

Primary Outcomes

Demonstration of bridging bone via CT

Time frame: Months 60 or greater

Subject function as determined by pain on weight bearing

Time frame: Months 60 or greater

Subject function as determined by AOFAS - AHS score

Time frame: Months 60 or greater

Subject function as determined by Foot Function Index

Time frame: Months 60 or greater

Central Contacts

Stephen Roach

CONTACT

615-656-7466 Stephen.Roach@wright.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Center for Bone and Joint Surgery

Royal Palm Beach, Florida, United States

RECRUITING

Illinois Bone and Joint Institute, LLC

Glenview, Illinois, United States

RECRUITING

MedStar Health Research Institute/ Union Memorial Hospital

Baltimore, Maryland, United States

RECRUITING

Orthopaedic Associates of Michigan, PC

Grand Rapids, Michigan, United States

RECRUITING

Michigan Orthopedic Center

Lansing, Michigan, United States

RECRUITING

Desert Orthopaedics

Las Vegas, Nevada, United States

RECRUITING

...and 16 more locations