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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)
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The purpose of this investigation is to compare functional outcome measures and range of motion for patients receiving glucocorticoid (GC) injections versus those not receiving GCs for the treatment of distal radius fractures. The investigators hypothesize that patients who receive GC will have improved ROM and functional outcome measures compared to patients who do not receive GC. In addition, this study aims to determine if there is a difference in rates of complications and postoperative pain control between the GC and non-GC groups. In order to accomplish these aims, the investigators will conduct a prospective, randomized, controlled investigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucocorticoid (GC) group | Experimental | 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 Intervention | No GC administration |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone |
|
| Measure | Description | Time Frame |
|---|---|---|
| QuickDASH | 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). | Pre-Op (day of consent) up through 12 months Post-Op |
| Visual Analog Scale Pain Score | 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). | Pre-Op (day of consent) up through 12 months Post-Op |
| PROMIS Pain Interference | 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). | Pre-Op visit (day of consent) |
| PROMIS Self-Efficacy Manage Symptoms | 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). | Pre-Op (day of consent) |
| PROMIS Upper Extremity (Short Form 7A) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liam Dwyer, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Woodbine | Danville | Pennsylvania | 17821 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | QuickDASH | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-Op (day of consent) up through 12 months Post-Op |
|
Through study completion, an average of 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hardware Prominence | General disorders | Non-systematic Assessment | One patient from the glucocorticoid group subsequently underwent removal of hardware at the surgeons discretion due to hardware prominence |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Liam Dwyer | Geisinger Medical Center | 5702716700 | ldwyer@geisinger.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2019 | Jan 13, 2026 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 2, 2019 | Dec 12, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Methylprednisolone | Drug | 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 |
|
| Pre-Op (day of consent) up through 12 months Post-Op |
| Control (Non-GC) Group |
No GC administration |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | 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) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 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) | Count of Participants | Participants |
|
| OG001 | Control (Non-GC) Group | No GC administration |
|
|
| Primary | Visual Analog Scale Pain Score | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-Op (day of consent) up through 12 months Post-Op |
|
|
|
| Primary | PROMIS Pain Interference | 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). | 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. | Posted | Number | participants | Pre-Op visit (day of consent) |
|
|
|
| Primary | PROMIS Self-Efficacy Manage Symptoms | 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). | 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. | Posted | Number | Number | Pre-Op (day of consent) |
|
|
|
| Primary | PROMIS Upper Extremity (Short Form 7A) | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-Op (day of consent) up through 12 months Post-Op |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
|
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011239 | Prednisolone |
| 2 Weeks Post-Op Mean |
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