Sarmiento Brace for Broken Arm

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Broken ArmPre-Fabricated Fracture Brace - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Broken Arm

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Week 2 post-treatment

Week 2 post-treatment
Incidence of cutaneous complications
Number of Tramadol Pills Taken
Score on PROMIS - Physical Function - Short Form 10b
Score on Pain Visual Analogue Scale (VAS)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Sarmiento Brace
1 of 2
Coaptation Splint
1 of 2

Active Control

66 Total Participants · 2 Treatment Groups

Primary Treatment: Sarmiento Brace · No Placebo Group · N/A

Sarmiento Brace
Procedure
ActiveComparator Group · 1 Intervention: Pre-Fabricated Fracture Brace · Intervention Types: Procedure
Coaptation Splint
Procedure
ActiveComparator Group · 1 Intervention: Webril Padded Plaster Splint · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 2 post-treatment

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,264 Previous Clinical Trials
753,525 Total Patients Enrolled
Abhishek Ganta, MDPrincipal InvestigatorNYU Langone Health

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
will result in patients having their fracture treated in one of two ways: If the fracture is less than or equal to two centimeters in diameter, the patient will have a percutaneous pinning procedure
An individual who is 18 years of age or older and skeletally mature is considered an adult for the purposes of surgery.
A patient with a femoral neck fracture is treated nonsurgically for the first 2 weeks.