Trial Outcomes & Findings for In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries (NCT NCT03017040)
NCT ID: NCT03017040
Last Updated: 2019-08-14
Results Overview
The questionnaire will help the investigators determine how much difficulty the subject has had with the injured wrist in the past week.
TERMINATED
NA
1 participants
at enrollment
2019-08-14
Participant Flow
Unit of analysis: Wrists
Participant milestones
| Measure |
Scapholunate Tear
Subjects with a full scapholunate (SL) tear will have a CT scan and fluoroscopy images taken. Subjects will enroll the injured wrist into the SL tear group and uninjured wrist into the control group. Thus each participant will flow into both study arms/groups and may appear to be counted twice, however, for this study we focus on number of wrists.
CT scan: A CT scan of the wrist
Fluoroscopy Scan: A fluoroscopy scan of the wrist.
|
Control Wrist
Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control. Subjects will enroll the injured wrist into the SL tear group and uninjured wrist into the control group. Thus each participant will flow into both study arms/groups and may appear to be counted twice, however, for this study we focus on number of wrists.
CT scan: A CT scan of the wrist
Fluoroscopy Scan: A fluoroscopy scan of the wrist.
|
|---|---|---|
|
Overall Study
STARTED
|
1 1
|
1 1
|
|
Overall Study
COMPLETED
|
0 0
|
0 0
|
|
Overall Study
NOT COMPLETED
|
1 1
|
1 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries
Baseline characteristics by cohort
| Measure |
Participants With Unilateral Scapholunate Tear
n=1 Participants
All subjects with a full scapholunate (SL) tear will have a CT scan and fluoroscopy images taken. The injured wrist will enroll in the SL tear group and the uninjured wrist as the control wrist.
CT scan: A CT scan of the wrist
Fluoroscopy Scan: A fluoroscopy scan of the wrist.
|
|---|---|
|
Age, Continuous
|
47 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at enrollmentPopulation: The paper-based questionnaire was not scored and tallied, thus not analyzed.
The questionnaire will help the investigators determine how much difficulty the subject has had with the injured wrist in the past week.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: at enrollmentPopulation: The paper-based questionnaire was not scored and tallied, thus not analyzed.
The SF-12 questionnaire will help the investigators determine how well subjects are able to do usual activities
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: at enrollmentPopulation: The paper-based questionnaire was not scored and tallied, thus not analyzed.
The DASH questionnaire will help the investigators determine the level of disability subjects face from the wrist injury.
Outcome measures
Outcome data not reported
Adverse Events
Scapholunate Tear
Control Wrist
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