Status:

WITHDRAWN

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

Lead Sponsor:

OrthoCarolina Research Institute, Inc.

Collaborating Sponsors:

Stryker Trauma and Extremities

Conditions:

Adult Acquired Flatfoot

Eligibility:

All Genders

25-75 years

Phase:

PHASE4

Brief 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 lengtheni...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

  • 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

Key Trial Info

Start Date :

March 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2011

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00949897

Start Date

March 1 2009

End Date

June 1 2011

Last Update

March 13 2013

Active Locations (1)

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OrthoCarolina, P.A.

Charlotte, North Carolina, United States, 28203