Adult Acquired Flatfoot
Conditions
Keywords
Adult Acquired Flatfoot, Biofoam Porous Metal Implant, Allograft Bone Wedge
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.
Interventions
DEVICEBiofoam
Device
OTHERIliac Crest Allograft with locked plate
Sponsors
Stryker Trauma and Extremities
OrthoCarolina Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 2 weeks, 6 weeks, 12 weeks, and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score | 2 weeks, 6 weeks, 3 months, and 6 months |
| Foot Function Index (FFI) Score | 2 weeks, 6 weeks, 3 months, and 6 months |
| Pain Visual Analog Scale (VAS) | 2 weeks, 6 weeks, 3 months, and 6 months |
| Implant failure | 2 weeks, 6 weeks, 3 months, and 6 months |
Countries
United States
Outcome results
None listed