Weightbearing Assessment of Tarsal Instability

NCT ID: NCT01868789

Last Updated: 2018-03-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-11-30

Brief Summary

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The purpose of this study is to compare the average joint motion and joint axis orientation of the hindfoot bones between patients diagnosed with adult-acquired flatfoot disorder (AAFD) and a control group of patients without foot deformity, using weight-bearing CT technology.

Detailed Description

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Conditions

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Adult-acquired Flatfoot Disorder (AAFD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Weightbearing CT (AAFD group)

Weightbearing CT scan of affected foot

Group Type EXPERIMENTAL

Weightbearing CT

Intervention Type RADIATION

Weightbearing CT (control group)

Weightbearing CT scan of normal foot

Group Type ACTIVE_COMPARATOR

Weightbearing CT

Intervention Type RADIATION

Interventions

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Weightbearing CT

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1\. adult patients (ages 18 -80 years old) diagnosed with Stage 2 AAFD


1\. adult patients (ages 18 -80 years old) without foot deformity

Exclusion Criteria

1. previous surgery
2. infection
3. tumor in the affected foot
4. pregnancy

Control group:


1. history of previous foot and ankle surgery
2. foot deformity
3. known foot and ankle pathology
4. pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CurveBeam LLC

UNKNOWN

Sponsor Role collaborator

Orthopedic Foot and Ankle Center, Ohio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory C Berlet, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Foot and Ankle Center

Locations

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Orthopedic Foot and Ankle Center

Westerville, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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OH1-12-00397

Identifier Type: -

Identifier Source: org_study_id

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