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

Phase 4

Withdrawn

• Conditions: Adult Acquired Flatfoot
• Interventions: Device: Biofoam; Other: Iliac Crest Allograft with locked plate

• Registration Number: NCT00949897
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

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 Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-31
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-11
• Last Update Posted: 2013-03-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofoam	Biofoam	-
Iliac Crest Allograft with locked plate	Iliac Crest Allograft with locked plate	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

OrthoCarolina, P.A.; 🇺🇸 Charlotte, North Carolina, United States