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Bracing vs Splinting for Broken Arm
N/A
Recruiting
Led By Abhishek Ganta, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age above 18 and skeletally mature
Treated non-operatively first 2 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2 post-treatment
Awards & highlights
Study Summary
This trial is testing which is better for arm fractures: a) a special brace or b) a splint. They will track pain, drugs needed, and function over 2 weeks.
Who is the study for?
This trial is for adults over 18 with a fresh break in the upper arm bone, who are being treated without surgery. It's not for those with cancer treatments, open fractures, multiple injuries at once, or prisoners.Check my eligibility
What is being tested?
The study compares two ways to keep the broken arm still right after injury: using a ready-made brace versus a padded plaster splint. Comfort, pain levels, need for painkillers and how well patients can use their arms will be checked over two weeks.See study design
What are the potential side effects?
Possible side effects may include discomfort from wearing the immobilization devices, skin irritation or pressure sores under the brace or splint, and potential increased pain if the device doesn't fit properly.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old and my bones have stopped growing.
Select...
I received non-surgical treatment for the first 2 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 2 post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2 post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Tramadol Pills Taken
Score on Pain Visual Analogue Scale (VAS)
Secondary outcome measures
Incidence of cutaneous complications
Score on PROMIS - Physical Function - Short Form 10b
Trial Design
2Treatment groups
Active Control
Group I: Sarmiento BraceActive Control1 Intervention
Group II: Coaptation SplintActive Control1 Intervention
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,363 Previous Clinical Trials
817,941 Total Patients Enrolled
Abhishek Ganta, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
151 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I received non-surgical treatment for the first 2 weeks.I am currently receiving treatment for cancer.I am over 18 years old and my bones have stopped growing.I have a broken bone that is exposed through my skin.My surgeon has decided that my injury requires surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Sarmiento Brace
- Group 2: Coaptation Splint
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies available for prospective participants in this trial?
"Affirmative. Clinicaltrials.gov has verified that this experiment is currently recruiting subjects, starting from the 20th of July 2021 and last updated on the 24th August 2022 - 66 participants are needed to be recruited from 3 separate sites."
Answered by AI
How many participants are enlisting in this experiment?
"Affirmative. The clinicaltrials.gov platform confirms that this trial, first posted in July of 2021, is presently recruiting participants; 66 people are required to be recruited at 3 separate medical sites."
Answered by AI
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