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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Device
OrthoCarolina, P.A.
Charlotte, North Carolina, United States
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
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
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