Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft
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|ClinicalTrials.gov Identifier: NCT02879149|
Recruitment Status : Recruiting
First Posted : August 25, 2016
Last Update Posted : March 27, 2018
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|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|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|
Standard Rigid Fixation plus autograft
Procedure: Standard of Care
Autologous Bone Graft
Standard rigid fixation plus AUGMENT® Bone Graft
Device: AUGMENT® Bone Graft
AUGMENT® Bone Graft
- 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 ]
Biospecimen Retention: Samples Without DNA
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 ClinicalTrials.gov identifier (NCT number): NCT02879149
|Contact: Stephen Roach||615-656-7466||Stephen.Roach@wright.com|
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