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

Primary Purpose

Adult Acquired Flatfoot

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Biofoam
Iliac Crest Allograft with locked plate
Sponsored by
OrthoCarolina Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Acquired Flatfoot focused on measuring Adult Acquired Flatfoot, Biofoam Porous Metal Implant, Allograft Bone Wedge

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • OrthoCarolina, P.A.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Biofoam

Iliac Crest Allograft with locked plate

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score
Foot Function Index (FFI) Score
Pain Visual Analog Scale (VAS)
Implant failure

Full Information

First Posted
July 29, 2009
Last Updated
March 11, 2013
Sponsor
OrthoCarolina Research Institute, Inc.
Collaborators
Stryker Trauma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00949897
Brief Title
Comparison Study of Biofoam Porous Metal Versus Allograft to Treat Adult Acquired Flatfoot
Official Title
A Randomized, Prospective, Controlled Trial for Lateral Column Lengthening in Adult Acquired Flatfoot Using Biofoam Porous Metal Compared With Allograft
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Funding terminated
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
OrthoCarolina Research Institute, Inc.
Collaborators
Stryker Trauma GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Acquired Flatfoot
Keywords
Adult Acquired Flatfoot, Biofoam Porous Metal Implant, Allograft Bone Wedge

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biofoam
Arm Type
Active Comparator
Arm Title
Iliac Crest Allograft with locked plate
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Biofoam
Other Intervention Name(s)
510(k) Number: K073535
Intervention Description
Device
Intervention Type
Other
Intervention Name(s)
Iliac Crest Allograft with locked plate
Other Intervention Name(s)
Iliac Crest Allograft
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score
Time Frame
2 weeks, 6 weeks, 3 months, and 6 months
Title
Foot Function Index (FFI) Score
Time Frame
2 weeks, 6 weeks, 3 months, and 6 months
Title
Pain Visual Analog Scale (VAS)
Time Frame
2 weeks, 6 weeks, 3 months, and 6 months
Title
Implant failure
Time Frame
2 weeks, 6 weeks, 3 months, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert B Anderson, MD
Organizational Affiliation
OrthoCarolina, P.A.
Official's Role
Principal Investigator
Facility Information:
Facility Name
OrthoCarolina, P.A.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States

12. IPD Sharing Statement

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

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