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OpenTrials
Completed

NCT Number: NCT04736537

A Study to Evaluate 4DCT Controls

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.

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Key information

Conditions

Wrist Ligament and Bone Disorders Bone Diseases Musculoskeletal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

4DCT

Device

CT imaging conceptually similar to time-lapse photography.

Primary outcomes

  1. Scapholunate (SL) Gapping

    Time frame: Baseline

    Normalized volar/dorsal location of the gapping at the scapholunate joint, measured in millimeters, at each of the 17 time steps during each movement.

  2. Radioscaphoid (RS) Gapping

    Time frame: Baseline

    Normalized volar/dorsal location of the gapping at the radioscaphoid joint, measured in millimeters, at each of the 17 time steps during each movement.

  3. Radiolunate (RL) Gapping

    Time frame: Baseline

    Normalized volar/dorsal location of the gapping at the radiolunate joint, measured in millimeters, at each of the 17 time steps during each movement.

Secondary outcomes

  1. Scaphotrapezium (STm) Gapping

    Time frame: Baseline

    Normalized volar/dorsal location of the gapping at the scaphotrapezium joint, measured in millimeters, at each of the 17 time steps during each movement.

  2. Scaphotrapezoid (STd) Gapping

    Time frame: Baseline

    Normalized volar/dorsal location of the gapping at the scaphotrapezoid joint, measured in millimeters, at each of the 17 time steps during each movement.

  3. Trapezoitrapezoid (TmTd) Gapping

    Time frame: Baseline

    Normalized volar/dorsal location of the gapping at the trapeziotrapezoid joint, measured in millimeters, at each of the 17 time steps during each movement.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2021
Registry last updated
May 2, 2024

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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