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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00949897
Study type Interventional
Source OrthoCarolina Research Institute, Inc.
Contact
Status Withdrawn
Phase Phase 4
Start date March 2009
Completion date June 2011