Back to resultsA Study to Evaluate 4DCT Controls
Primary Purpose
Wrist Ligament and Bone Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
4DCT
Sponsored by
About this trial
This is an interventional basic science trial for Wrist Ligament and Bone Disorders
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy Controls
Arm Description
Outcomes
Primary Outcome Measures
Scapholunate 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.
Radioscaphoid 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.
Radiolunate 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.
Secondary Outcome Measures
Scaphotrapezium 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.
Scaphotrapezoid 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.
Trapezoitrapezoid 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.
Full Information
NCT ID
NCT04736537
First Posted
January 11, 2021
Last Updated
May 5, 2023
Sponsor
Mayo Clinic
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT04736537
Brief Title
A Study to Evaluate 4DCT Controls
Official Title
4DCT Wrist Biomarkers During Resisted and Unresisted Tasks in Healthy Controls
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
April 6, 2023 (Actual)
Study Completion Date
April 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrist Ligament and Bone Disorders
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Controls
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
4DCT
Intervention Description
CT imagining conceptually similar to time-lapse photography.
Primary Outcome Measure Information:
Title
Scapholunate gapping
Description
Normalized volar/dorsal location of the gapping at the scapholunate joint, measured in millimeters, at each of the 17 time steps during each movement.
Time Frame
Baseline
Title
Radioscaphoid gapping
Description
Normalized volar/dorsal location of the gapping at the radioscaphoid joint, measured in millimeters, at each of the 17 time steps during each movement.
Time Frame
Baseline
Title
Radiolunate gapping
Description
Normalized volar/dorsal location of the gapping at the radiolunate joint, measured in millimeters, at each of the 17 time steps during each movement.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Scaphotrapezium gapping
Description
Normalized volar/dorsal location of the gapping at the radiolunate joint, measured in millimeters, at each of the 17 time steps during each movement.
Time Frame
Baseline
Title
Scaphotrapezoid gapping
Description
Normalized volar/dorsal location of the gapping at the radiolunate joint, measured in millimeters, at each of the 17 time steps during each movement.
Time Frame
Baseline
Title
Trapezoitrapezoid gapping
Description
Normalized volar/dorsal location of the gapping at the radiolunate joint, measured in millimeters, at each of the 17 time steps during each movement.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin D. Zhao, Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study to Evaluate 4DCT Controls
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