Distal Radius Steroid | NCT05655130

Studies
Distal Radius Steroid

NCT05655130

Sponsor

Indiana Hand to Shoulder Center

Status

Terminated

Last Update Posted

Jan 23, 2024Actual

Enrollment

30Actual

Phase

Phase 1

Conditions

Fractures, Bone
Fractures, Closed
Radius Fracture Distal

Interventions

Dexamethasone
Methylprednisolone
Standard of Care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low participation rate

Expanded Access Info

Start Date

Nov 6, 2018Actual

Primary Completion Date

May 2, 2023Actual

Completion Date

May 2, 2023Actual

First Submitted Date

Dec 6, 2022

First Submission Date that Met QC Criteria

Dec 14, 2022

First Posted Date

Dec 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2024

Last Update Posted Date

Jan 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary goal of this study is to compare functional outcomes (range of motion [flexion, extension, supination, pronation], return to work, of patients with distal radius fractures who receive intraoperative glucocorticoids to those that do not. Secondary goals include comparison of pain control (number of pain pills consumed, visual analog scale (VAS) pain scores) between patients with distal radius fractures who receive intraoperative glucocorticoids to those that do not. The primary endpoint of this study will occur when 18 patients in each test-group complete the 6 month follow up visit for study.

Detailed Description

This will be a prospective, randomized, partially blinded, controlled trial where patients are randomized in a centralized fashion into 2 groups: a) Control group with no intraoperative glucocorticoids administered or b) Test group with administration of 10 mg glucocorticoids intraoperatively followed with a 6-day oral methylprednisolone taper course prescribed as a Medrol Dose Pack. Each group will enroll 30 patients for a study total of 60 over approximately a one year enrollment period. Randomization will be set up using sealedenvelope.com simple randomizer. The randomization process will ensure balance between both arms based on sex and age of patients enrolled. All patients scheduled for distal radius ORIF will be screened to meet inclusion/exclusion criteria. Patients will be randomized preoperatively by the research coordinator, based on a 1:1 weighting, upon obtaining to consent to either Control or Test group. Post-op therapists will be blinded to the patient treatment group until completion of protocol activities for each patient.

After surgery, patients will be followed for a duration of at least 6 months. Interval follow-up information will be collected at 10 days, 6 weeks, 3 months, and 6 months.

3-view wrist radiographs will be taken at each follow-up visit.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Group	Experimental	Test Group will receive 10mg intravenous dexamethasone at the time of incision, administered by the assigned anesthesiologist. Post-surgery, Test Group patients will be prescribed a 6-day oral methylprednisolone taper course.	Drug: Dexamethasone Drug: Methylprednisolone
Control Group	Other	Standard of care with no placebo	Other: Standard of Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	Intraoperative 10 mg IV Dose	Test Group
Methylprednisolone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Range of Motion	Active and Passive degrees of flexion, extension in the wrist. Forearm degrees of supination and pronation	comparison of 10 days to 6 months post-operative measurements

Secondary Outcomes

Measure	Description	Time Frame
Visual Analogue Scale (VAS) Pain	patient rates pain on a visual scale from no pain to worst possible pain	6 Months

Other Outcomes

Measure	Description	Time Frame
Return to Work	comparison of patient's work schedule/limitations from baseline to 6 months (off study)	6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Intra- or extra-articular distal radius fractures (AO 23-A2,3; 23B-1,2,3; 23C-1,2,3) treated with open reduction internal fixation (ORIF)
Age >18

Exclusion Criteria:

Open fractures
Pathologic fractures
Concomitant ipsilateral upper extremity fracture (not including distal ulna)
Medical contraindication to systemic glucocorticoids (insulin-dependent Diabetes mellitus, history of avascular necrosis, allergy)
Narcotic dependence
Women who are pregnant or breastfeeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indiana Hand to Shoulder Center		Indianapolis	Indiana	46260	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050723	Fractures, Bone
D005596	Fractures, Closed
D000092503	Wrist Fractures

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D014954	Wrist Injuries
D001134	Arm Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone
D008775	Methylprednisolone
D059039	Standard of Care

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided