A Study to Evaluate 4DCT Controls
4DCT Wrist Biomarkers During Resisted and Unresisted Tasks in Healthy Controls
2 other identifiers
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2021
CompletedFirst Posted
Study publicly available on registry
February 3, 2021
CompletedStudy Start
First participant enrolled
August 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2023
CompletedResults Posted
Study results publicly available
May 2, 2024
CompletedMay 2, 2024
May 1, 2024
8 months
January 11, 2021
April 5, 2024
May 1, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (3)
Scaphotrapezium (STm) Gapping
Baseline
Scaphotrapezoid (STd) Gapping
Baseline
Trapezoitrapezoid (TmTd) Gapping
Baseline
Study Arms (1)
Healthy Controls
EXPERIMENTALInterventions
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tyson Scrabeck
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Kristin D. Zhao, Ph.D.
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 11, 2021
First Posted
February 3, 2021
Study Start
August 4, 2022
Primary Completion
April 6, 2023
Study Completion
April 6, 2023
Last Updated
May 2, 2024
Results First Posted
May 2, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share