UnknownNot Applicable

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

94 participantsStarted 2019-08

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Must be willing and able to provide informed consent and be available for the planned follow-up evaluations and radiologic tests; and
. Must have been included in the Augment Injectable propensity score matching population from the Augment Injectable summary of safety and effectiveness data (SSED).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain on weight bearing via Visual Analog Scale (VAS)

Timeframe: Visit 1 (Day 0)

Trial details

NCT IDNCT03998137

SponsorBioMimetic Therapeutics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-06

Contact for this trial

Justin Moss

615-236-4984 justin.moss@wright.com

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