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

Study Overview
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Brief Summary
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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.

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

Conditions
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Adult Acquired Flatfoot

Intervention / Treatment
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* Device: Biofoam
* Other: Iliac Crest Allograft with locked plate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biofoam<br> | Device: Biofoam<br>* Device<br>* Other names: 510(k) Number: K073535;|
| Active Comparator: Iliac Crest Allograft with locked plate<br> | Other: Iliac Crest Allograft with locked plate<br> <br> * Other names: Iliac Crest Allograft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult Acquired Flatfoot, Biofoam Porous Metal Implant, Allograft Bone Wedge