Wrist Ligament and Bone Disorders
Conditions
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.
Interventions
DEVICE4DCT
CT imaging conceptually similar to time-lapse photography.
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scapholunate (SL) Gapping | 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. |
| Radioscaphoid (RS) Gapping | 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. |
| Radiolunate (RL) Gapping | 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
| Measure | Time frame | Description |
|---|---|---|
| Scaphotrapezium (STm) Gapping | 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. |
| Scaphotrapezoid (STd) Gapping | 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. |
| Trapezoitrapezoid (TmTd) Gapping | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Controls 4DCT: CT imaging conceptually similar to time-lapse photography. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Healthy Controls |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age, Continuous | 29.2 years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Healthy Controls | Radiolunate (RL) Gapping | Radioulnar load, unresisted | 1.81 millimeters |
| Healthy Controls | Radiolunate (RL) Gapping | radioulnar load, resisted | 1.88 millimeters |
| Healthy Controls | Radiolunate (RL) Gapping | Flexion-extension load, unresisted | 1.56 millimeters |
| Healthy Controls | Radiolunate (RL) Gapping | Flexion-extension load, resisted | 1.79 millimeters |
| Healthy Controls | Radiolunate (RL) Gapping | Grip load, unresisted | 1.77 millimeters |
| Healthy Controls | Radiolunate (RL) Gapping | Grip load, resisted | 1.76 millimeters |
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Healthy Controls | Radioscaphoid (RS) Gapping | Radioulnar load, unresisted | 1.42 millimeters |
| Healthy Controls | Radioscaphoid (RS) Gapping | Radioulnar load, resisted | 1.39 millimeters |
| Healthy Controls | Radioscaphoid (RS) Gapping | Flexion-extension, unresisted | 1.52 millimeters |
| Healthy Controls | Radioscaphoid (RS) Gapping | Flexion-extension, resisted | 1.50 millimeters |
| Healthy Controls | Radioscaphoid (RS) Gapping | Grip load, unresisted | 1.48 millimeters |
| Healthy Controls | Radioscaphoid (RS) Gapping | Grip load, resisted | 1.49 millimeters |
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Healthy Controls | Scapholunate (SL) Gapping | Radioulnar load, unresisted | 1.65 millimeters |
| Healthy Controls | Scapholunate (SL) Gapping | Radioulnar load, resisted | 1.64 millimeters |
| Healthy Controls | Scapholunate (SL) Gapping | Flexion-extension load, unresisted | 1.86 millimeters |
| Healthy Controls | Scapholunate (SL) Gapping | Flexion-extension load, resisted | 1.92 millimeters |
| Healthy Controls | Scapholunate (SL) Gapping | Grip load, unresisted | 1.83 millimeters |
| Healthy Controls | Scapholunate (SL) Gapping | Grip load, resisted | 1.79 millimeters |
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Healthy Controls | Scaphotrapezium (STm) Gapping | Grip load, unresisted | 1.14 millimeters |
| Healthy Controls | Scaphotrapezium (STm) Gapping | Radioulnar load, unresisted | 1.06 millimeters |
| Healthy Controls | Scaphotrapezium (STm) Gapping | Radioulnar load, resisted | 1.13 millimeters |
| Healthy Controls | Scaphotrapezium (STm) Gapping | Flexion-extension load, unresisted | 1.18 millimeters |
| Healthy Controls | Scaphotrapezium (STm) Gapping | Flexion-extension load, resisted | 1.13 millimeters |
| Healthy Controls | Scaphotrapezium (STm) Gapping | Grip load, resisted | 1.10 millimeters |
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Healthy Controls | Scaphotrapezoid (STd) Gapping | Radioulnar load, unresisted | 0.97 millimeters |
| Healthy Controls | Scaphotrapezoid (STd) Gapping | Radioulnar load, resisted | 1.04 millimeters |
| Healthy Controls | Scaphotrapezoid (STd) Gapping | Flexion-extension load, unresisted | 1.09 millimeters |
| Healthy Controls | Scaphotrapezoid (STd) Gapping | Flexion-extension load, resisted | 1.09 millimeters |
| Healthy Controls | Scaphotrapezoid (STd) Gapping | Grip load, unresisted | 1.26 millimeters |
| Healthy Controls | Scaphotrapezoid (STd) Gapping | Grip load, resisted | 1.19 millimeters |
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Healthy Controls | Trapezoitrapezoid (TmTd) Gapping | Radioulnar load, unresisted | 0.52 millimeters |
| Healthy Controls | Trapezoitrapezoid (TmTd) Gapping | Radioulnar load, resisted | 0.55 millimeters |
| Healthy Controls | Trapezoitrapezoid (TmTd) Gapping | Flexion-extension load, unresisted | 0.54 millimeters |
| Healthy Controls | Trapezoitrapezoid (TmTd) Gapping | Flexion-extension load, resisted | 0.54 millimeters |
| Healthy Controls | Trapezoitrapezoid (TmTd) Gapping | Grip load, unresisted | 0.54 millimeters |
| Healthy Controls | Trapezoitrapezoid (TmTd) Gapping | Grip load, resisted | 0.55 millimeters |