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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 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.


Detailed Summary:
Sponsor: OrthoCarolina Research Institute, Inc.

Current Primary Outcome: The degree of correction as measured by talonavicular coverage angle, which is used to quantify the degree of deformity. Degree of correction is defined as the difference between the preoperative and postoperative talonavicular coverage angle. [ Time Frame: 2 weeks, 6 weeks, 12 weeks, and 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score [ Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months ]
  • Foot Function Index (FFI) Score [ Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months ]
  • Pain Visual Analog Scale (VAS) [ Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months ]
  • Implant failure [ Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months ]


Original Secondary Outcome: Same as current

Information By: OrthoCarolina Research Institute, Inc.

Dates:
Date Received: July 29, 2009
Date Started: March 2009
Date Completion:
Last Updated: March 11, 2013
Last Verified: March 2013