Weightbearing Assessment of Tarsal Instability

NCT01868789 | Completed Results

• 1 other identifier: OH1-12-00397
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adult-acquired Flatfoot Disorder (AAFD)

Keywords

Adult-acquired flatfoot disorder (AAFD); flexible flatfoot; computed tomography (CT)

Outcome Measures

Primary Outcomes (2)

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

  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.

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

• Change in Navicular Rotation Between Touch-down Bearing and 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.

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

Study Arms (2)

Weightbearing CT (AAFD group)

EXPERIMENTAL

Weightbearing CT scan of affected foot

Radiation: Weightbearing CT

Weightbearing CT (control group)

ACTIVE COMPARATOR

Weightbearing CT scan of normal foot

Radiation: Weightbearing CT

Interventions

Weightbearing CT RADIATION

Weightbearing CT (AAFD group); Weightbearing CT (control group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• previous surgery
• infection
• tumor in the affected foot
• pregnancy
• Control group:
• \. adult patients (ages 18 -80 years old) without foot deformity
• history of previous foot and ankle surgery
• foot deformity
• known foot and ankle pathology
• pregnancy

Sponsors & Collaborators

• Orthopedic Foot and Ankle Center, Ohio: lead
• CurveBeam LLC: collaborator

Study Sites (1)

Orthopedic Foot and Ankle Center

Westerville, Ohio, 43082, United States

Location

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

Any movement during the scanning process or metal implants caused difficulty with reconstructing the positioning of the bones, therefore those subjects were eliminated from analysis.

Results Point of Contact

• Title: Dr. Gregory Berlet
• Organization: Orthopedic Foot and Ankle Center

ofacresearch@orthofootankle.com

6148958747

Study Officials

• Gregory C Berlet, MD

  Orthopedic Foot and Ankle Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: June 5, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 1, 2018
• Results First Posted: January 18, 2018

Record last verified: 2018-01

Locations

US (1)