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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR071338 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Controls | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4DCT | Device | CT imaging conceptually similar to time-lapse photography. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Scaphotrapezoid (STd) Gapping |
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Inclusion Criterion:
Exclusion Criteria (applied to both wrists for control subjects):
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| Name | Affiliation | Role |
|---|---|---|
| Kristin D. Zhao, Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Controls | 4DCT: CT imaging conceptually similar to time-lapse photography. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Controls | 4DCT: CT imaging conceptually similar to time-lapse photography. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Full Range | millimeters | Baseline |
|
|
Single scanning visit, approximately 30 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Controls | 4DCT: CT imaging conceptually similar to time-lapse photography. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tyson Scrabeck | Mayo Clinic | 507-538-1016 | scrabeck.tyson@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2023 | Apr 1, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 16, 2022 | Apr 1, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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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 |
| 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 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 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. | Posted | Median | Full Range | millimeters | 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. | Posted | Median | Full Range | millimeters | 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. | Posted | Median | Full Range | millimeters | 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. | Posted | Median | Full Range | millimeters | 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. | Posted | Median | Full Range | millimeters | Baseline |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
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| Flexion-extension, resisted |
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| Grip load, unresisted |
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| Grip load, resisted |
|
|
| Flexion-extension load, resisted |
|
| Grip load, unresisted |
|
| Grip load, resisted |
|
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| Flexion-extension load, resisted |
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| Grip load, unresisted |
|
| Grip load, resisted |
|
|
| Flexion-extension load, resisted |
|
| Grip load, unresisted |
|
| Grip load, resisted |
|
|
| Flexion-extension load, resisted |
|
| Grip load, unresisted |
|
| Grip load, resisted |
|