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Sedation Methods for Broken Bones Treatment (DRIFT Trial)

N/A

Recruiting

Led By Jospeh Janicki, MD

Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, aged 4-10 years

Diagnosis of 100% dorsally displaced radius metaphyseal fracture with any or no ulna involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 year

Awards & highlights

DRIFT Trial Summary

This trial compares outcomes of children with broken bones treated with or without sedation.

Who is the study for?

This trial is for boys and girls aged 4-10 with a specific type of broken wrist bone (distal radius fracture) that happened within the last 10 days. They must be able to undergo treatment in an OR or ED, and their parents need to consent and commit to the study's requirements. Children with growth plate involvement, open or pathological fractures, neuromuscular or metabolic diseases are excluded.Check my eligibility

What is being tested?

The study compares two ways of treating children's broken wrists: one group will have the bones set while sedated ('sedated reduction'), while another group won't have this procedure. The goal is to see which method leads to better use of the hand after healing.See study design

What are the potential side effects?

Possible side effects may include discomfort from immobilization, risks associated with sedation such as nausea or breathing difficulties during reduction, and potential complications from not having formal bone setting.

DRIFT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 4 and 10 years old.

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I have a specific type of broken wrist bone.

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My fracture is recent and can be treated in the OR or ED.

DRIFT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

functional and patient reported outcomes

Secondary outcome measures

Disabilities of the Arm, Shoulder and Hand (DASH) S/PA

Estimated unit cost data for hospital and patient charges and costs

Follow-up Disabilities of the Arm, Shoulder and Hand (DASH) S/PA

+8 more

DRIFT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Non-sedated ImmobilizationExperimental Treatment1 Intervention

Immobilization in a cast without reduction

Group II: Formal ReductionActive Control1 Intervention

closed reduction under conscious sedation followed by casting

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Immobilization

2021

N/A

~270

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor

258 Previous Clinical Trials

5,188,796 Total Patients Enrolled

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH

485 Previous Clinical Trials

1,086,566 Total Patients Enrolled

Jospeh Janicki, MDPrincipal InvestigatorAnn and Robert H. Lurie Children's Hospital of Chicago

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial accepting participants past the age of eighty?

"This medical study is looking for participants aged 4 to 10. There are 63 trials open to minors and 303 studies for seniors over 65 years of age."

Answered by AI

How many participants are involved in this trial?

"Affirmative. The clinicaltrials.gov website reveals that this experiment is presently recruiting participants, which began on February 16th 2022 and was last altered on August 30th 2023. A total of 334 patients are needed to be enrolled across 9 medical centres."

Answered by AI

What is the current number of centers participating in this clinical trial?

"At this stage of the trial, nine separate medical sites are onboarding participants. These locations include Indianapolis, Baltimore and Boston alongside other cities across the country. To reduce travel costs associated with being part of this research study, it is beneficial to select a site located in your vicinity."

Answered by AI

Is recruitment ongoing for this research program?

"Correct. Per the clinicaltrials.gov portal, this research endeavour is presently seeking participants and has been since its launch on February 16th 2022. The trial is currently recruiting 334 patients from 9 distinct medical centres."

Answered by AI

May I take part in this clinical experiment?

"The clinical trial seeks 334 participants between the ages of 4 and 10 who have a distal radius fracture. Additionally, they must supply signed documentation from a parent or legal guardian; agree to comply with all study procedures for its duration; be male or female; present an 100% dorsally displaced radium metaphyseal fracture that is less than 5 cm away from the growth plate; adhere to an immobilization regimen which began within 10 days prior to consenting and being assigned treatment arm, as well as having access to operation rooms (OR) or reduction in emergency departments (ED)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Distal Radius Interventions for Fracture Treatment

2022. "Distal Radius Interventions for Fracture Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05131685.