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

NCT00949897 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2013-03-13

No results posted yet for this study

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

DEVICE

Biofoam

Device

OTHER

Iliac Crest Allograft with locked plate

Sponsors & Collaborators

  • Stryker Trauma and Extremities

    collaborator INDUSTRY

  • OrthoCarolina Research Institute, Inc.

    lead OTHER

Principal Investigators

  • Robert B Anderson, MD · OrthoCarolina, P.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00949897 on ClinicalTrials.gov