Comparison Study of Biofoam Porous Metal Versus Allograft to Treat Adult Acquired Flatfoot
Withdrawn before enrolling · Phase 4
Conditions studied: Adult Acquired Flatfoot
In brief
The purpose of this study is to compare the clinical and radiographic outcomes of a randomized, consecutive series of adult patients, with an acquired flatfoot, treated with a lateral column lengthening using an allograft bone wedge versus a titanium porous metal implant (Biofoam, Wright Medical). 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.
Key facts
- Study ID
- NCT00949897
- Run by
- OrthoCarolina Research Institute, Inc.
- People needed
- 0
- Starts
- 2009-03-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2013-03-13
Who can join
Age: 25 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ages 25-75
- 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)
You may not qualify if…
- Less than 25 years of age and greater than 75 years
- Pre-existing infection
- Peripheral neuropathy
- Charcot arthropathy
- Peripheral vascular disease
- Rhematoid Arthritis (RA) or inflammatory arthropathy
- Metal allergy or sensitivity to metal
Where it is running
- OrthoCarolina, P.A. — Charlotte, North Carolina, United States
Full record on ClinicalTrials.gov
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