NCT00949897

Comparison Study of Biofoam Porous Metal Versus Allograft to Treat Adult Acquired Flatfoot

A Randomized, Prospective, Controlled Trial for Lateral Column Lengthening in Adult Acquired Flatfoot Using Biofoam Porous Metal Compared With Allograft

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: OrthoCarolina Research Institute, Inc. · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adult Acquired Flatfoot

Interventions

Type	Name	Description
DEVICE	Biofoam	Device
OTHER	Iliac Crest Allograft with locked plate

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-07-31
• Last updated: 2013-03-13

Locations

1 site across 1 country: United States