- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03998137
Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft
A Prospective, Controlled, Multi-Center, Post-Approval Trial to Evaluate the Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Justin Moss
- Phone Number: 615-236-4984
- Email: justin.moss@wright.com
Study Contact Backup
- Name: Dana Haywood
- Phone Number: 615-236-4963
- Email: JohnDana.Haywood@wright.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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).
Exclusion Criteria:
1) Subjects that were excluded from the safety analysis in the BMTI-2009-01 or BMTI-2010-01 study. These subjects were consented, but never treated as part of the BMTI-2009-01 or BMTI-2010-01 protocol.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Autograft
Standard Rigid Fixation plus autograft
|
Autologous Bone Graft
|
AUGMENT® Injectable
Standard rigid fixation plus AUGMENT® Injectable Bone Graft
|
AUGMENT® Injectable Bone Graft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain on weight bearing via Visual Analog Scale (VAS)
Time Frame: Visit 1 (Day 0)
|
Subjects were asked to stand and report pain on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).
|
Visit 1 (Day 0)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confirmation of bridging bone via computerized tomography (CT)
Time Frame: Visit 1 (Day 0)
|
Overall Assessment of Osseous Bridging (% Bone Bridging; CT Scans)
|
Visit 1 (Day 0)
|
AOFAS (American Orthopaedic Foot & Ankle Society) Hindfoot and Ankle Score
Time Frame: Visit 1 (Day 0)
|
Subjects were asked to report pain, functionality and ability levels while the physician performed assessments based on alignment, abnormality, motion, and stability.
The total score ranges from a low of zero to a high of 100, with subscales measuring pain (40 points), function (50 points), and alignment (10 points), with higher scores showing better outcomes.
|
Visit 1 (Day 0)
|
Foot Function Index, FFI
Time Frame: Visit 1 (Day 0)
|
The Foot Function Index (FFI) measures the impact of foot pathology on function in terms of pain, disability and activity restriction.
The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales all ranging from 0-100.
To obtain a sub-scale score, the item scores for a sub-scale are totaled and then divided by the maximum total possible for all of the sub-scale items which the subject indicated were applicable.
Any item marked as not applicable is excluded from the total possible.
Sub-scales are an average of the completed ratings within that sub-scale.
The total foot function score is an average of the three sub-scale scores and ranges from 0-100.
Lower scores are indicative of better outcomes whereas higher scores indicate greater impairment.
|
Visit 1 (Day 0)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BMTI-2018-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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