Trial Outcomes & Findings for Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures (NCT NCT03898154)
NCT ID: NCT03898154
Last Updated: 2026-04-30
Results Overview
QuickDash scale is designed to measure physical function and symptoms in patients with musculoskeletal disorders of the upper extremity (arm, shoulder, and hand). Scale is 0-100, with 0 being no disability (best outcome) and 100 being full disability (worst outcome).
TERMINATED
PHASE4
38 participants
Pre-Op (day of consent) up through 12 months Post-Op
2026-04-30
Participant Flow
Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm). No analysis was completed, and study was administratively closed.
Participant milestones
| Measure |
Glucocorticoid (GC) Group
Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone Postoperative: A 6-day oral methylprednisolone (oral GC) taper course. The oral GC taper course begins on the day of surgery and includes 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day 6
Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm). No analysis was completed, and study was administratively closed.
|
Control (Non-GC) Group
No GC administration
Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm). No analysis was completed, and study was administratively closed.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
|
Overall Study
COMPLETED
|
15
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
Baseline characteristics by cohort
| Measure |
Glucocorticoid (GC) Group
n=18 Participants
Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone Postoperative: A 6-day oral methylprednisolone (oral GC) taper course. The oral GC taper course begins on the day of surgery and includes 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day 6
|
Control (Non-GC) Group
n=20 Participants
No GC administration
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=14 Participants
|
14 Participants
n=34 Participants
|
29 Participants
n=69 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=14 Participants
|
6 Participants
n=34 Participants
|
9 Participants
n=69 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=14 Participants
|
15 Participants
n=34 Participants
|
32 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=14 Participants
|
5 Participants
n=34 Participants
|
6 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
1 Participants
n=34 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
1 Participants
n=69 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
0 Participants
n=34 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
0 Participants
n=69 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
0 Participants
n=34 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
0 Participants
n=69 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
0 Participants
n=34 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
0 Participants
n=69 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
|
Race (NIH/OMB)
White
|
18 Participants
n=14 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
19 Participants
n=34 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
37 Participants
n=69 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
0 Participants
n=34 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
0 Participants
n=69 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
0 Participants
n=34 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
0 Participants
n=69 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
0 Participants
n=34 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
0 Participants
n=69 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=14 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
20 Participants
n=34 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
38 Participants
n=69 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
0 Participants
n=34 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
0 Participants
n=69 Participants • Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm)
|
PRIMARY outcome
Timeframe: Pre-Op (day of consent) up through 12 months Post-OpPopulation: The results reflect only the QuickDash data recorded from patient assessment. Data was not collected for some timepoints because the QuickDash assessment is part of routine clinical care, not research-specific, so its timing is pre-determined based on clinical standard care needs rather than protocol study timepoints. Therefore, some participants have no results if the assessment was not aligned with their clinic visit.
QuickDash scale is designed to measure physical function and symptoms in patients with musculoskeletal disorders of the upper extremity (arm, shoulder, and hand). Scale is 0-100, with 0 being no disability (best outcome) and 100 being full disability (worst outcome).
Outcome measures
| Measure |
Glucocorticoid (GC) Group
n=15 Participants
Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone Postoperative: A 6-day oral methylprednisolone (oral GC) taper course. The oral GC taper course begins on the day of surgery and includes 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day 6.
|
Control (Non-GC) Group
n=20 Participants
No GC administration
|
|---|---|---|
|
QuickDASH
6 Weeks Post-Op Mean
|
40.4 score on a scale
Standard Deviation 25.5
|
24.7 score on a scale
Standard Deviation 10.4
|
|
QuickDASH
3 Months Post-Op Mean
|
24.8 score on a scale
Standard Deviation 25.3
|
16.2 score on a scale
Standard Deviation 17.7
|
|
QuickDASH
6 Monts Post-Op Mean
|
13.4 score on a scale
Standard Deviation 17.6
|
6.6 score on a scale
Standard Deviation 4.1
|
|
QuickDASH
12 Months Post-Op Mean
|
8.9 score on a scale
Standard Deviation 12.3
|
12 score on a scale
Standard Deviation 13.2
|
|
QuickDASH
2 Weeks Post-Op Mean
|
45.4 score on a scale
Standard Deviation 27.1
|
67.7 score on a scale
Standard Deviation 16.1
|
|
QuickDASH
Pre-Op Mean
|
73.7 score on a scale
Standard Deviation 25.6
|
76.7 score on a scale
Standard Deviation 22.4
|
PRIMARY outcome
Timeframe: Pre-Op (day of consent) up through 12 months Post-OpPopulation: The results reflect only the VAS Pain data recorded from patient assessment. Data was not collected for some timepoints because the VAS Pain assessment is part of routine clinical care, not research-specific, so its timing is pre-determined based on clinical standard care needs rather than protocol study time points. Therefore, some participants have no results if the assessment was not aligned with their clinic visit.
Visual Analog Scale Pain Score is a subjective pain scale reported by patients to assess current pain levels for their condition being seen in clinic. Scale is 0-10, with 0 being no pain at all (best outcome), 10 being worst pain imaginable (worst outcome).
Outcome measures
| Measure |
Glucocorticoid (GC) Group
n=15 Participants
Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone Postoperative: A 6-day oral methylprednisolone (oral GC) taper course. The oral GC taper course begins on the day of surgery and includes 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day 6.
|
Control (Non-GC) Group
n=20 Participants
No GC administration
|
|---|---|---|
|
Visual Analog Scale Pain Score
Pre-Op Mean
|
6.1 score on a scale
Standard Deviation 2.7
|
4.6 score on a scale
Standard Deviation 2.7
|
|
Visual Analog Scale Pain Score
2 Weeks Post-Op Mean
|
2.8 score on a scale
Standard Deviation 3.1
|
2.8 score on a scale
Standard Deviation 2.0
|
|
Visual Analog Scale Pain Score
6 Weeks Post-Op Mean
|
2.0 score on a scale
Standard Deviation 2.8
|
1.9 score on a scale
Standard Deviation 1.7
|
|
Visual Analog Scale Pain Score
3 Months Post-Op Mean
|
2.4 score on a scale
Standard Deviation 3.1
|
1.1 score on a scale
Standard Deviation 2.1
|
|
Visual Analog Scale Pain Score
6 Months Post-Op Mean
|
1.72 score on a scale
Standard Deviation 2.43
|
0.51 score on a scale
Standard Deviation 0.71
|
|
Visual Analog Scale Pain Score
12 Months Post-Op Mean
|
0.8 score on a scale
Standard Deviation 1.4
|
1.9 score on a scale
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: Pre-Op visit (day of consent)Population: No patients completed the PROMIS Pain Interference because this assessment is part of routine clinical care and is not research-specific, so this data was erroneously not collected. There are no plans to collect this data in the future.
PROMIS Pain Interference scale measuring how pain impacts daily activities, social life, and emotional well-being. Scale is 40.7- 77 with 40.7 being the no impact on activity (best outcome), and 77 being worst impact on daily activity (worst outcome).
Outcome measures
| Measure |
Glucocorticoid (GC) Group
Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone Postoperative: A 6-day oral methylprednisolone (oral GC) taper course. The oral GC taper course begins on the day of surgery and includes 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day 6.
|
Control (Non-GC) Group
No GC administration
|
|---|---|---|
|
PROMIS Pain Interference
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Pre-Op (day of consent)Population: No patients completed the PROMIS Self-Efficacy because this assessment is part of routine clinical care and is not research-specific, so this data was erroneously not collected. There are no plans to collect this data in the future.
PROMIS Self-Efficacy Manage Symptoms is a scale that measures a person's confidence in managing symptoms, such as pain or fatigue, and preventing them from interfering with daily life. Scale is 22.67-63.85 with 22.67 meaning no confidence in managing symptoms (worst outcome) and 63.85 being full confidence in managing symptoms (best outcome).
Outcome measures
| Measure |
Glucocorticoid (GC) Group
Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone Postoperative: A 6-day oral methylprednisolone (oral GC) taper course. The oral GC taper course begins on the day of surgery and includes 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day 6.
|
Control (Non-GC) Group
No GC administration
|
|---|---|---|
|
PROMIS Self-Efficacy Manage Symptoms
|
0 Number
|
0 Number
|
PRIMARY outcome
Timeframe: Pre-Op (day of consent) up through 12 months Post-OpPopulation: The results reflect only the PROMIS Upper Extremity data recorded from patient assessment. Data was not collected for some timepoints because the PROMIS Upper Extremity assessment is part of routine clinical care, not research-specific, so its timing is pre-determined based on clinical standard care needs rather than protocol study time points. Therefore, some participants have no results if the assessment was not aligned with their clinic visit.
PROMIS Upper Extremity Scale measures the self-reported functioning of the arms, shoulders, hands, and fingers. Scale is 16.3-58.2, with 16.3 being severe functional impact (worst outcome) and 58.2 being no functional issues (best outcome).
Outcome measures
| Measure |
Glucocorticoid (GC) Group
n=15 Participants
Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone Postoperative: A 6-day oral methylprednisolone (oral GC) taper course. The oral GC taper course begins on the day of surgery and includes 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day 6.
|
Control (Non-GC) Group
n=20 Participants
No GC administration
|
|---|---|---|
|
PROMIS Upper Extremity (Short Form 7A)
Pre-Op Mean
|
21 score on a scale
Standard Deviation 1.7
|
20.6 score on a scale
Standard Deviation 8.5
|
|
PROMIS Upper Extremity (Short Form 7A)
2 Weeks Post-Op Mean
|
27.8 score on a scale
Standard Deviation 8.0
|
27.4 score on a scale
Standard Deviation 10.4
|
|
PROMIS Upper Extremity (Short Form 7A)
6 Weeks Post-Op Mean
|
35.6 score on a scale
Standard Deviation 12.7
|
37.8 score on a scale
Standard Deviation 17.5
|
|
PROMIS Upper Extremity (Short Form 7A)
3 Months Post-Op Mean
|
45.4 score on a scale
Standard Deviation 11.9
|
38.0 score on a scale
Standard Deviation 13.2
|
|
PROMIS Upper Extremity (Short Form 7A)
6 Months Post-Op Mean
|
49.5 score on a scale
Standard Deviation 12.2
|
46.2 score on a scale
Standard Deviation 14.5
|
|
PROMIS Upper Extremity (Short Form 7A)
12 Months Post-Op Mean
|
53.1 score on a scale
Standard Deviation 10.8
|
48.0 score on a scale
Standard Deviation 15.0
|
Adverse Events
Glucocorticoid (GC) Group
Control (Non-GC) Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Glucocorticoid (GC) Group
n=15 participants at risk
Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone Postoperative: A 6-day oral methylprednisolone (oral GC) taper course. The oral GC taper course begins on the day of surgery and includes 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day 6
Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm). No analysis was completed, and study was administratively closed.
|
Control (Non-GC) Group
n=20 participants at risk
No GC administration
Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm). No analysis was completed, and study was administratively closed.
|
|---|---|---|
|
General disorders
Hardware Prominence
|
6.7%
1/15 • Through study completion, an average of 1 year
|
0.00%
0/20 • Through study completion, an average of 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place