A Study to Evaluate 4DCT Controls

Wrist Ligament and Bone Disorders Clinical Trial

Official title:

4DCT Wrist Biomarkers During Resisted and Unresisted Tasks in Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04736537
• Other study ID #: 20-007668
• Secondary ID: R01AR071338
• Status: Completed
• Phase: N/A
• Start date: August 4, 2022
• Est. completion date: April 6, 2023

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to use CT motion pictures (4DCT) to visualize and record how much space there is between certain wrist joint bones, both without any resistance and with light resistance to the movement, during a single scanning visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 6, 2023
• Est. primary completion date: April 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criterion:

• Age = 18 and = 60 years.

• Control subjects without any history of wrist injury or disease.

Exclusion Criteria (applied to both wrists for control subjects):

• Previously-diagnosed rheumatological conditions or connective tissue diseases;

• Inability to be appropriately positioned in the scanner for the imaging;

• Congenital malformations of the wrist or forearm;

• Diagnosed wrist osteoarthritis

• Age under 18 or over 60.

Related Conditions & MeSH terms

• Bone Diseases
• Wrist Ligament and Bone Disorders

Intervention

Device:
• 4DCT
CT imaging conceptually similar to time-lapse photography.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scapholunate (SL) Gapping	Normalized volar/dorsal location of the gapping at the scapholunate joint, measured in millimeters, at each of the 17 time steps during each movement.	Baseline
Primary	Radioscaphoid (RS) Gapping	Normalized volar/dorsal location of the gapping at the radioscaphoid joint, measured in millimeters, at each of the 17 time steps during each movement.	Baseline
Primary	Radiolunate (RL) Gapping	Normalized volar/dorsal location of the gapping at the radiolunate joint, measured in millimeters, at each of the 17 time steps during each movement.	Baseline
Secondary	Scaphotrapezium (STm) Gapping	Normalized volar/dorsal location of the gapping at the scaphotrapezium joint, measured in millimeters, at each of the 17 time steps during each movement.	Baseline
Secondary	Scaphotrapezoid (STd) Gapping	Normalized volar/dorsal location of the gapping at the scaphotrapezoid joint, measured in millimeters, at each of the 17 time steps during each movement.	Baseline
Secondary	Trapezoitrapezoid (TmTd) Gapping	Normalized volar/dorsal location of the gapping at the trapeziotrapezoid joint, measured in millimeters, at each of the 17 time steps during each movement.	Baseline