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Short vs Long Arm Casts for Broken Arms

N/A
Recruiting
Led By Emiyl R Dodwell, MD MPH FRCSC
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients aged 4-12 years
Displaced distal third forearm fracture (physeal, metaphyseal, meta-diaphyseal) requiring closed reduction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 months
Awards & highlights

Study Summary

This trial will study whether short arm casts are just as effective as long arm casts for treating broken arms in kids.

Who is the study for?
This trial is for children aged 4-12 with a specific type of broken wrist bone that's out of place and needs to be set without surgery. Kids 4-9 must have bones angled over 30 degrees or shifted completely, while those 10-12 need an angle over 15 degrees or more than half shifted. It's not for kids getting other bone procedures, with open fractures, re-broken bones, nerve damage issues, or known weak bones.Check my eligibility
What is being tested?
The study compares two types of casts for treating displaced wrist fractures in kids: short arm vs long arm fiberglass casts after setting the bone without surgery. The goal is to see if the shorter cast works as well as the longer one by looking at whether the break stays in place and how it affects pain, function, and activity.See study design
What are the potential side effects?
Possible side effects include skin irritation from the cast material, stiffness in the elbow due to immobilization by a long arm cast, discomfort from wearing either type of cast, and very rarely burns from tools used to remove the cast.

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 12 years old.
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I have a broken forearm near the wrist that needed to be realigned without surgery.
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My child's bone is bent more than 30 degrees or completely shifted out of place.
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My child's bone is bent more than 15 degrees or shifted over half its width.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patients requiring repeat intervention due to loss of alignment
Secondary outcome measures
Comfort assessed by patient reported outcomes - Scale
Number of Participants with complications
Pain assessed by patient reported outcomes - Surveys
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Short Arm Fiberglass CastExperimental Treatment2 Interventions
Conscious sedation will be provided to patient while the reduction is performed by a cast trained orthopedic resident using standard techniques under fluoroscopic guidance. The arm will be held by an assistant or finger traps in the absence thereof. The arm will not be suspended until after the manipulation is performed. A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be complete at this point if the patient is assigned to the short arm cast group. The mold will then be applied and cast construct will be bivalved and taped.
Group II: Long Arm Fiberglass CastActive Control2 Interventions
Conscious sedation will be provided to patient while the reduction is performed by a cast trained orthopedic resident using standard techniques under fluoroscopic guidance. The arm will be held by an assistant or finger traps in the absence thereof. The arm will not be suspended until after the manipulation is performed. A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be extended to the shoulder joint if the patient is assigned to the long arm cast group. The mold will then be applied and cast construct will be bivalved and taped.

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor
243 Previous Clinical Trials
58,930 Total Patients Enrolled
Emiyl R Dodwell, MD MPH FRCSCPrincipal InvestigatorHospital for Special Surgery, New York

Media Library

Closed Reduction Clinical Trial Eligibility Overview. Trial Name: NCT03835065 — N/A
Distal Forearm Fractures Research Study Groups: Short Arm Fiberglass Cast, Long Arm Fiberglass Cast
Distal Forearm Fractures Clinical Trial 2023: Closed Reduction Highlights & Side Effects. Trial Name: NCT03835065 — N/A
Closed Reduction 2023 Treatment Timeline for Medical Study. Trial Name: NCT03835065 — N/A

Frequently Asked Questions

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

Do I fulfill the prerequisites to participate in this medical trial?

"Eligibility criteria for this trial stipulates that candidates aged 4 to 12 must have suffered from a fracture or bone-related injury. The experiment is seeking 400 participants in total."

Answered by AI

What is the uppermost participant cap for this clinical experiment?

"Affirmative. The information provided by clinicaltrials.gov depicts that this medical trial has been open for applications since February 12th 2019 and is currently recruiting patients, with 400 total participants sought from a single site."

Answered by AI

Are new participants being solicited for this experiment?

"Yes, the information posted on clinicaltrials.gov confirms that this medical study is in need of 400 subjects from 1 center. This recruitment effort was initially announced February 12th 2019 and last updated October 27th 2022."

Answered by AI

Are individuals aged 35 and above being considered as participants in this research?

"Participants for this experiment must be younger than 12 years old and have surpassed their 4th birthday."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Long Arm Vs Short Arm Fiberglass Cast for Treatment of Displaced Distal Radius Fractures
2019. "Long Arm Vs Short Arm Fiberglass Cast for Treatment of Displaced Distal Radius Fractures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03835065.
~51 spots leftby Feb 2025
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