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

NCT03998137 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 94

Last updated 2019-07-09

No results posted yet for this study

Summary

The objective of this long-term study is to evaluate the long-term effectiveness and safety of AUGMENT® Injectable Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated under protocol BMTI-2009-01 or BMTI-2010-01 or treated with autograft 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-2009-01 or BMTI-2010-01.

STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® Injectable Bone Graft is maintained and remains comparable to that of autologous bone graft over long-term subject follow-up.

REGULATORY PHASE: Post-approval study

Conditions

  • Ankle and Hindfoot Arthrodesis

Interventions

DEVICE

AUGMENT® Injectable Bone Graft

AUGMENT® Injectable Bone Graft

PROCEDURE

Standard of Care

Autologous Bone Graft

Sponsors & Collaborators

  • BioMimetic Therapeutics

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-31
Primary Completion
2021-06-30
Completion
2021-06-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03998137 on ClinicalTrials.gov