Trial Outcomes & Findings for 4DCT Imaging for Improved Diagnosis and Treatment of Wrist Ligament Injuries (NCT NCT03193996)
NCT ID: NCT03193996
Last Updated: 2024-06-05
Results Overview
Baseline, Post-4DCT Viewing, Post-Arthroscopy estimates or observations were made by the attending surgeon of Geissler grading, an arthroscopic classification of carpal instability and suggested management of acute injuries to the SLIL. Lower Geissler grading indicates milder damage and suggests more conservative injury management, and higher Geissler grading indicates more severe damage and suggests more aggressive injury management.
COMPLETED
NA
29 participants
Baseline, Post-4DCT Viewing, Post-Arthroscopy
2024-06-05
Participant Flow
Participant milestones
| Measure |
SLIL Injury
Surgical interventions for all subjects will be determined based on combined findings of both 4DCT and standard arthroscopy.
4DCT: 4DCT will be used to assess the location of the torn scapholunate interosseus ligament.
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|---|---|
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Overall Study
STARTED
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29
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Overall Study
COMPLETED
|
16
|
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Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
SLIL Injury
Surgical interventions for all subjects will be determined based on combined findings of both 4DCT and standard arthroscopy.
4DCT: 4DCT will be used to assess the location of the torn scapholunate interosseus ligament.
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|---|---|
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Overall Study
Withdrawal by Subject
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4
|
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Overall Study
Lost to Follow-up
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4
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Subject did not proceed to reconstructive surgery.
|
1
|
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Overall Study
Complicating disease
|
1
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Baseline Characteristics
4DCT Imaging for Improved Diagnosis and Treatment of Wrist Ligament Injuries
Baseline characteristics by cohort
| Measure |
SLIL Injury
n=29 Participants
Surgical interventions for all subjects will be determined based on combined findings of both 4DCT and standard arthroscopy.
4DCT: 4DCT will be used to assess the location of the torn scapholunate interosseus ligament.
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|---|---|
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Age, Continuous
|
41.7 years
STANDARD_DEVIATION 13 • n=39 Participants
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Sex: Female, Male
Female
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5 Participants
n=39 Participants
|
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Sex: Female, Male
Male
|
24 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
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Region of Enrollment
United States
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29 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Baseline, Post-4DCT Viewing, Post-ArthroscopyPopulation: All participants who underwent 4DCT scanning were analyzed for suspected change in Geissler grade. A subset of participants who proceeded to arthroscopy were analyzed for grading agreement between arthroscopy and 4DCT scan, and between arthroscopy and clinical suspicion prior to the 4DCT scan occurring.
Baseline, Post-4DCT Viewing, Post-Arthroscopy estimates or observations were made by the attending surgeon of Geissler grading, an arthroscopic classification of carpal instability and suggested management of acute injuries to the SLIL. Lower Geissler grading indicates milder damage and suggests more conservative injury management, and higher Geissler grading indicates more severe damage and suggests more aggressive injury management.
Outcome measures
| Measure |
SLIL Injury
n=22 Participants
Surgical interventions for all subjects will be determined based on combined findings of both 4DCT and standard arthroscopy.
4DCT: 4DCT will be used to assess the location of the torn scapholunate interosseus ligament.
|
|---|---|
|
Equivalency of 4DCT-based Treatment Plan to Arthroscopic-based Treatment Plan.
Agreement in Geissler stage between arthroscopy and 4DCT.
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14 Participants
|
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Equivalency of 4DCT-based Treatment Plan to Arthroscopic-based Treatment Plan.
4DCT changed suspected Geissler stage
|
5 Participants
|
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Equivalency of 4DCT-based Treatment Plan to Arthroscopic-based Treatment Plan.
Agreement in Geissler stage between arthroscopy and clinical suspicion pre-4DCT
|
11 Participants
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SECONDARY outcome
Timeframe: Baseline and 1 Year Post-SurgeryPopulation: All subjects who completed 1-year follow-up evaluation
Baseline and one year post-surgery Patient-Rated Wrist Evaluation (PRWE) Score will measure patient perception of change. The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, with higher numbers representing more pain and disability, and consists of 2 subscales as well as a total score: Pain subscale: contains 5 items each of which is further rated from 0-10. The maximum score in this section is 50 and minimum 0, with a higher score suggesting more severe and frequent pain. Function subscale: contains total 10 items. The maximum score in this section is 50 and minimum 0, with a higher score suggesting greater difficulty performing activities of daily living. Total score: all subscales together. The maximum score in this section is 100 and minimum 0, with a higher score suggesting more pain and disability overall.
Outcome measures
| Measure |
SLIL Injury
n=16 Participants
Surgical interventions for all subjects will be determined based on combined findings of both 4DCT and standard arthroscopy.
4DCT: 4DCT will be used to assess the location of the torn scapholunate interosseus ligament.
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|---|---|
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Subject Perception of Surgical Outcome
Pain domain change between baseline and 1-year post surgery
|
-12.5 score on a scale
Interval -18.0 to -6.0
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Subject Perception of Surgical Outcome
Functional impairment change between baseline and 1-year post surgery
|
-4.5 score on a scale
Interval -7.5 to -2.0
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Subject Perception of Surgical Outcome
Total PRWE score change between baseline and 1-year post surgery
|
-20 score on a scale
Interval -24.3 to -8.5
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Adverse Events
SLIL Injury
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