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

March 11, 2013 updated by: OrthoCarolina Research Institute, Inc.

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • OrthoCarolina, P.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Biofoam
Device: Biofoam
Device
Other Names:
  • 510(k) Number: K073535
Active Comparator: Iliac Crest Allograft with locked plate
Other: Iliac Crest Allograft with locked plate
Other Names:
  • Iliac Crest Allograft

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 2 weeks, 6 weeks, 12 weeks, and 6 months
2 weeks, 6 weeks, 12 weeks, and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score
Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months
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
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
2 weeks, 6 weeks, 3 months, and 6 months
Implant failure
Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months
2 weeks, 6 weeks, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OrthoCarolina Research Institute, Inc.

Collaborators

Stryker Trauma GmbH

Investigators

  • Principal Investigator: Robert B Anderson, MD, OrthoCarolina, P.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

July 29, 2009

First Submitted That Met QC Criteria

July 29, 2009

First Posted (Estimate)

July 31, 2009

Study Record Updates

Last Update Posted (Estimate)

March 13, 2013

Last Update Submitted That Met QC Criteria

March 11, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 120813B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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