Trial Outcomes & Findings for A Study to Evaluate 4DCT Controls (NCT NCT04736537)
NCT ID: NCT04736537
Last Updated: 2024-05-02
Results Overview
Normalized volar/dorsal location of the gapping at the scapholunate joint, measured in millimeters, at each of the 17 time steps during each movement.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Baseline
Results posted on
2024-05-02
Participant Flow
Participant milestones
| Measure |
Healthy Controls
4DCT: CT imaging conceptually similar to time-lapse photography.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate 4DCT Controls
Baseline characteristics by cohort
| Measure |
Healthy Controls
n=31 Participants
4DCT: CT imaging conceptually similar to time-lapse photography.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.2 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineNormalized volar/dorsal location of the gapping at the scapholunate joint, measured in millimeters, at each of the 17 time steps during each movement.
Outcome measures
| Measure |
Healthy Controls
n=31 Participants
4DCT: CT imaging conceptually similar to time-lapse photography.
|
|---|---|
|
Scapholunate (SL) Gapping
Radioulnar load, unresisted
|
1.65 millimeters
Interval 1.15 to 2.52
|
|
Scapholunate (SL) Gapping
Radioulnar load, resisted
|
1.64 millimeters
Interval 1.24 to 2.54
|
|
Scapholunate (SL) Gapping
Flexion-extension load, unresisted
|
1.86 millimeters
Interval 1.29 to 3.3
|
|
Scapholunate (SL) Gapping
Flexion-extension load, resisted
|
1.92 millimeters
Interval 1.32 to 3.29
|
|
Scapholunate (SL) Gapping
Grip load, unresisted
|
1.83 millimeters
Interval 1.14 to 3.04
|
|
Scapholunate (SL) Gapping
Grip load, resisted
|
1.79 millimeters
Interval 0.97 to 2.95
|
PRIMARY outcome
Timeframe: BaselineNormalized volar/dorsal location of the gapping at the radioscaphoid joint, measured in millimeters, at each of the 17 time steps during each movement.
Outcome measures
| Measure |
Healthy Controls
n=31 Participants
4DCT: CT imaging conceptually similar to time-lapse photography.
|
|---|---|
|
Radioscaphoid (RS) Gapping
Radioulnar load, unresisted
|
1.42 millimeters
Interval -0.49 to 2.04
|
|
Radioscaphoid (RS) Gapping
Radioulnar load, resisted
|
1.39 millimeters
Interval -1.15 to 1.72
|
|
Radioscaphoid (RS) Gapping
Flexion-extension, unresisted
|
1.52 millimeters
Interval 0.59 to 1.96
|
|
Radioscaphoid (RS) Gapping
Flexion-extension, resisted
|
1.50 millimeters
Interval 0.95 to 1.75
|
|
Radioscaphoid (RS) Gapping
Grip load, unresisted
|
1.48 millimeters
Interval 0.82 to 1.83
|
|
Radioscaphoid (RS) Gapping
Grip load, resisted
|
1.49 millimeters
Interval 0.89 to 1.8
|
PRIMARY outcome
Timeframe: BaselineNormalized volar/dorsal location of the gapping at the radiolunate joint, measured in millimeters, at each of the 17 time steps during each movement.
Outcome measures
| Measure |
Healthy Controls
n=31 Participants
4DCT: CT imaging conceptually similar to time-lapse photography.
|
|---|---|
|
Radiolunate (RL) Gapping
Grip load, resisted
|
1.76 millimeters
Interval 1.49 to 2.16
|
|
Radiolunate (RL) Gapping
Radioulnar load, unresisted
|
1.81 millimeters
Interval 0.28 to 2.03
|
|
Radiolunate (RL) Gapping
radioulnar load, resisted
|
1.88 millimeters
Interval 1.29 to 2.06
|
|
Radiolunate (RL) Gapping
Flexion-extension load, unresisted
|
1.56 millimeters
Interval 0.39 to 2.18
|
|
Radiolunate (RL) Gapping
Flexion-extension load, resisted
|
1.79 millimeters
Interval 1.19 to 2.05
|
|
Radiolunate (RL) Gapping
Grip load, unresisted
|
1.77 millimeters
Interval 1.36 to 2.12
|
SECONDARY outcome
Timeframe: BaselineNormalized volar/dorsal location of the gapping at the scaphotrapezium joint, measured in millimeters, at each of the 17 time steps during each movement.
Outcome measures
| Measure |
Healthy Controls
n=31 Participants
4DCT: CT imaging conceptually similar to time-lapse photography.
|
|---|---|
|
Scaphotrapezium (STm) Gapping
Radioulnar load, unresisted
|
1.06 millimeters
Interval 0.83 to 1.65
|
|
Scaphotrapezium (STm) Gapping
Radioulnar load, resisted
|
1.13 millimeters
Interval 0.84 to 1.66
|
|
Scaphotrapezium (STm) Gapping
Flexion-extension load, unresisted
|
1.18 millimeters
Interval 0.65 to 1.75
|
|
Scaphotrapezium (STm) Gapping
Flexion-extension load, resisted
|
1.13 millimeters
Interval 0.75 to 1.56
|
|
Scaphotrapezium (STm) Gapping
Grip load, unresisted
|
1.14 millimeters
Interval 0.77 to 1.71
|
|
Scaphotrapezium (STm) Gapping
Grip load, resisted
|
1.10 millimeters
Interval 0.75 to 1.68
|
SECONDARY outcome
Timeframe: BaselineNormalized volar/dorsal location of the gapping at the scaphotrapezoid joint, measured in millimeters, at each of the 17 time steps during each movement.
Outcome measures
| Measure |
Healthy Controls
n=31 Participants
4DCT: CT imaging conceptually similar to time-lapse photography.
|
|---|---|
|
Scaphotrapezoid (STd) Gapping
Grip load, unresisted
|
1.26 millimeters
Interval 0.55 to 1.62
|
|
Scaphotrapezoid (STd) Gapping
Radioulnar load, unresisted
|
0.97 millimeters
Interval 0.79 to 1.66
|
|
Scaphotrapezoid (STd) Gapping
Radioulnar load, resisted
|
1.04 millimeters
Interval 0.62 to 1.59
|
|
Scaphotrapezoid (STd) Gapping
Flexion-extension load, unresisted
|
1.09 millimeters
Interval 0.61 to 1.39
|
|
Scaphotrapezoid (STd) Gapping
Flexion-extension load, resisted
|
1.09 millimeters
Interval 0.57 to 1.37
|
|
Scaphotrapezoid (STd) Gapping
Grip load, resisted
|
1.19 millimeters
Interval 0.42 to 1.51
|
SECONDARY outcome
Timeframe: BaselineNormalized volar/dorsal location of the gapping at the trapeziotrapezoid joint, measured in millimeters, at each of the 17 time steps during each movement.
Outcome measures
| Measure |
Healthy Controls
n=31 Participants
4DCT: CT imaging conceptually similar to time-lapse photography.
|
|---|---|
|
Trapezoitrapezoid (TmTd) Gapping
Radioulnar load, unresisted
|
0.52 millimeters
Interval 0.32 to 0.78
|
|
Trapezoitrapezoid (TmTd) Gapping
Radioulnar load, resisted
|
0.55 millimeters
Interval 0.32 to 0.77
|
|
Trapezoitrapezoid (TmTd) Gapping
Flexion-extension load, unresisted
|
0.54 millimeters
Interval 0.34 to 0.83
|
|
Trapezoitrapezoid (TmTd) Gapping
Flexion-extension load, resisted
|
0.54 millimeters
Interval 0.36 to 0.79
|
|
Trapezoitrapezoid (TmTd) Gapping
Grip load, unresisted
|
0.54 millimeters
Interval 0.31 to 0.75
|
|
Trapezoitrapezoid (TmTd) Gapping
Grip load, resisted
|
0.55 millimeters
Interval 0.3 to 0.73
|
Adverse Events
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place