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Completed

NCT Number: NCT01868789

Weightbearing Assessment of Tarsal Instability

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.

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Key information

Conditions

Adult-acquired Flatfoot Disorder (AAFD) Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Flatfoot Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Talipes

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopedic Foot and Ankle Center

Westerville, Ohio, 43082, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Symptomatic group:

Inclusion criteria

  • adult patients (ages 18 -80 years old) diagnosed with Stage 2 AAFD

Exclusion criteria

  • previous surgery
  • infection
  • tumor in the affected foot
  • pregnancy

Control group:

Inclusion criteria

  • adult patients (ages 18 -80 years old) without foot deformity

Exclusion criteria

  • history of previous foot and ankle surgery
  • foot deformity
  • known foot and ankle pathology
  • pregnancy

Treatment and study plan

Weightbearing CT

Radiation

Primary outcomes

  1. Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular

    Time frame: 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing

    Relative motion, which is the position of the full weightbearing (FWB, greater that 75-100% body weight) navicular in comparison to the touch down weightbearing (TDWB, 25-50% body weight) navicular position, will be determined by comparing the joint orientation across these two points on one CT scan. The difference between the two positions is reported below.

  2. Change in Navicular Rotation Between Touch-down Bearing and Full-weight Bearing

    Time frame: 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing

    Relative motion across joint segments will be determined by comparing the joint orientation across two time points: touch-down bearing (TDWB, 25-50% body weight) and full-weight bearing (FWB, greater that 75-100% body weight) as measured on CT.

Sponsors and collaborators

Lead sponsor

Orthopedic Foot and Ankle Center, Ohio

Other

Collaborators

  • CurveBeam LLC

Registry information

Official study title

In-Vivo Physiologic Weight-Bearing Assessment of Tarsal Instability: Three-Dimensional Cone-Beam Computed Tomography Analysis

Acronym: WBCT

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 5, 2013
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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