Comparison Study of Biofoam Porous Metal Versus Allograft to Treat Adult Acquired Flatfoot
NCT ID: NCT00949897
Last Updated: 2013-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2009-03-31
2011-06-30
Brief Summary
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Null hypothesis: At six months postoperatively, there is no difference in the degree of correction as measured by the talonavicular coverage angle between patients randomized to allograft and Biofoam.
Alternative hypothesis: At six months postoperatively, the degree of correction as measured by the talonavicular coverage angle will be less in patients randomized to allograft than the degree of correction in patients randomized to Biofoam.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Biofoam
Biofoam
Device
Iliac Crest Allograft with locked plate
Iliac Crest Allograft with locked plate
Interventions
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Biofoam
Device
Iliac Crest Allograft with locked plate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unresponsive to conservative treatment
* Patient with acquired flatfoot deformity, who is a candidate for lateral column lengthening (Stage IIB) = (greater than \> 40% uncoverage of talar head by navicular on standing AP radiograph)
Exclusion Criteria
* Pre-existing infection
* Peripheral neuropathy
* Charcot arthropathy
* Peripheral vascular disease
* Rhematoid Arthritis (RA) or inflammatory arthropathy
* Metal allergy or sensitivity to metal
25 Years
75 Years
ALL
No
Sponsors
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Stryker Trauma and Extremities
INDUSTRY
OrthoCarolina Research Institute, Inc.
OTHER
Responsible Party
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OrthoCarolina Research Institute, Inc.
Principal Investigators
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Robert B Anderson, MD
Role: PRINCIPAL_INVESTIGATOR
OrthoCarolina, P.A.
Locations
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OrthoCarolina, P.A.
Charlotte, North Carolina, United States
Countries
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Other Identifiers
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120813B
Identifier Type: -
Identifier Source: org_study_id
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