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

OrthoCarolina Research Institute, Inc.

Status and phase: Withdrawn; Phase 4

Conditions: Adult Acquired Flatfoot

Treatments: Device: Biofoam; Other: Iliac Crest Allograft with locked plate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00949897

120813B

Details and patient eligibility

About

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.

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Biofoam

Active Comparator group

Treatment:

Device: Biofoam

Iliac Crest Allograft with locked plate

Active Comparator group

Treatment:

Other: Iliac Crest Allograft with locked plate