Distal Radius FracturePhase 4NCT03898154

Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures

A Phase 4 study testing Dexamethasone and Methylprednisolone in people with Distal Radius Fracture, run by C. Liam Dwyer at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Distal Radius Fracture
What is being tested?: Dexamethasone and Methylprednisolone
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: 10 Jul 2019to 19 Dec 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient 18 years of age and older.
Patients undergoing ORIF with VP fixation of an acute, isolated DRF with or without associated distal ulna fracture and with or without associated carpal tunnel release

Who cannot join

Worker's compensation patient
Non-operatively treated fractures
Open fractures
Preoperative neurovascular injury
Coexisting fractures or injuries
Diabetes mellitus

Show all 10Show fewer

Allergy or contraindication to GCs
Associated non-orthopedic injury that would prohibit the administration of GCs
Patients currently incarcerated
Pregnant patients

Trial locations and contacts

1 site in 1 country.

United States1 site

Geisinger Woodbine
Danville, Pennsylvania, 17821

Other trials in United States

About this study

Official title: The Effect on Wrist Range of Motion With Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures: A Randomized Controlled Trial

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.

Conditions: Distal Radius Fracture
Being tested: Dexamethasone, Methylprednisolone
Medical subject headings: Wrist Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexamethasoneDrug
Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone
MethylprednisoloneDrug
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 groups in NCT03898154
Study group	Role	What they receive
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 Receives: Drug: Dexamethasone; Drug: Methylprednisolone
Control (non-GC) group	No intervention	No GC administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Pre-Op (day of consent) up through 12 months Post-Op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 201919 Dec 2024

First posted1 Apr 2019
Study start10 Jul 2019
Primary completion19 Dec 2024
Study completion19 Dec 2024

Why it stopped: 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)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Distal Radius FractureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03898154
Sponsor's protocol ID: 2018-0533
Status last verified: Mar 2026
First submitted: 28 Mar 2019
Last updated: 30 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture

All Distal Radius Fracture trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect on Wrist Range of Motion With Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03898154
Acronym / sponsor ID: 2018-0533
Conditions: Distal Radius Fracture
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: 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)
Enrolment: 38 participants (actual)
Lead sponsor: C. Liam DwyerUniversity, hospital or other
Study start: 10 Jul 2019 (actual)
Primary completion: 19 Dec 2024 (actual)
Study completion: 19 Dec 2024 (actual)
First posted: 1 Apr 2019 (actual)
Results: Posted 30 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Glucocorticoid (GC) group	Experimental	Drug: Dexamethasone, Drug: MethylprednisoloneIntraoperative: 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patient 18 years of age and older.
Patients undergoing ORIF with VP fixation of an acute, isolated DRF with or without associated distal ulna fracture and with or without associated carpal tunnel release

Key exclusion criteria (10 listed)

Worker's compensation patient
Non-operatively treated fractures
Open fractures
Preoperative neurovascular injury
Coexisting fractures or injuries

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexamethasoneIntraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone	Drug	Glucocorticoid (GC) group
MethylprednisolonePostoperative: 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	Drug	Glucocorticoid (GC) group

Primary outcome

QuickDASH
Time frame: Pre-Op (day of consent) up through 12 months Post-Op
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).
Visual Analog Scale Pain Score
Time frame: Pre-Op (day of consent) up through 12 months Post-Op
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).
PROMIS Pain Interference
Time frame: Pre-Op visit (day of consent)
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).
PROMIS Self-Efficacy Manage Symptoms
Time frame: Pre-Op (day of consent)
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).
PROMIS Upper Extremity (Short Form 7A)
Time frame: Pre-Op (day of consent) up through 12 months Post-Op
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).

Results and safety

Results posted to the registry on 30 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Glucocorticoid (GC) Group	18	15
Control (Non-GC) Group	20	20

Primary outcome: QuickDASH

Time frame: Pre-Op (day of consent) up through 12 months Post-Op. Mean (Standard Deviation). Unit: score on a scale

Measure	Glucocorticoid (GC) Group n = 15	Control (Non-GC) Group n = 20
Pre-Op Mean	73.7 (25.6)	76.7 (22.4)
2 Weeks Post-Op Mean	45.4 (27.1)	67.7 (16.1)
6 Weeks Post-Op Mean	40.4 (25.5)	24.7 (10.4)
3 Months Post-Op Mean	24.8 (25.3)	16.2 (17.7)
6 Monts Post-Op Mean	13.4 (17.6)	6.6 (4.1)
12 Months Post-Op Mean	8.9 (12.3)	12 (13.2)

Population analysed: 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.

Primary outcome: Visual Analog Scale Pain Score

Time frame: Pre-Op (day of consent) up through 12 months Post-Op. Mean (Standard Deviation). Unit: score on a scale

Measure	Glucocorticoid (GC) Group n = 15	Control (Non-GC) Group n = 20
Pre-Op Mean	6.1 (2.7)	4.6 (2.7)
2 Weeks Post-Op Mean	2.8 (3.1)	2.8 (2.0)
6 Weeks Post-Op Mean	2.0 (2.8)	1.9 (1.7)
3 Months Post-Op Mean	2.4 (3.1)	1.1 (2.1)
6 Months Post-Op Mean	1.72 (2.43)	0.51 (0.71)
12 Months Post-Op Mean	0.8 (1.4)	1.9 (3.8)

Population analysed: 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.

Primary outcome: PROMIS Pain Interference

Time frame: Pre-Op visit (day of consent). Number. Unit: participants

Measure	Glucocorticoid (GC) Group n = 0	Control (Non-GC) Group n = 0
Value	0	0

Population analysed: 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.

Primary outcome: PROMIS Self-Efficacy Manage Symptoms

Time frame: Pre-Op (day of consent). Number. Unit: Number

Measure	Glucocorticoid (GC) Group n = 0	Control (Non-GC) Group n = 0
Value	0	0

Population analysed: 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.

Adverse events

Time frame: Through study completion, an average of 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Glucocorticoid (GC) Group	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15
Control (Non-GC) Group	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Distal Radius Fracture

Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Liam Dwyer, MD principal investigator

Geisinger Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexamethasone and Methylprednisolone in people with Distal Radius Fracture, run by C. Liam Dwyer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

QuickDASH (time frame: Pre-Op (day of consent) up through 12 months Post-Op). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03898154.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.