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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05118087
Other study ID # 21-00438
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 20, 2021
Est. completion date July 6, 2025

Study information

Verified date July 2023
Source NYU Langone Health
Contact Abhishek Ganta, MD
Phone 718-206-6923
Email abhishek.ganta@nyulangone.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to determine which initial method of immobilization for humeral shaft fractures in the emergency room maximizes patient comfort. The two methods of initial management for humeral shaft fractures are sarmiento bracing (pre-fabricated fracture brace) and coaptation splinting. In this study, the team will compare patient related outcomes and comfort for each method of initial management of humeral shaft fractures. Participant pain, narcotic usage, and function will be tracked over a 2 week period to see which method of immobilization is preferred.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date July 6, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Presenting to an emergency room or ICARE in the participating centers with an acute humeral shaft fracture 2. Age above 18 and skeletally mature 3. Isolated Injury 4. Treated non-operatively first 2 weeks Exclusion Criteria: 1. Open fractures 2. Poly trauma 3. Injuries deemed operative by attending surgeon 4. Patients undergoing treatment for malignancy 5. Prisoners

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Webril Padded Plaster Splint
Patients in the coaptation splint group will have a webril padded plaster splint that is placed around the humerus. The forearm and wrist are then suspended in a cuff and collar.
Pre-Fabricated Fracture Brace
Patients in the sarmiento group will be given a fitted pre-fabricated fracture brace with a cuff and collar for the forearm. The patients will be educated on brace maintained, tightening, and care during at the time of the ER encounter.

Locations

Country Name City State
United States NYU Winthrop Hospital Garden City New York
United States NYU Langone Health New York New York
United States Jamaica Hospital Medical Center Queens New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Score on Pain Visual Analogue Scale (VAS) The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. The total range of score is 0 (no pain) to 10 (unbearable pain); the higher the pain, the greater the amount of pain. Week 1 post-treatment
Primary Score on Pain Visual Analogue Scale (VAS) The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. The total range of score is 0 (no pain) to 10 (unbearable pain); the higher the pain, the greater the amount of pain. Week 2 post-treatment
Primary Number of Tramadol Pills Taken All patients will be discharged with 28 pills of tramadol 50mg. At week 1 follow-up, number of tramadol pills taken will be reported. Week 1 post-treatment
Primary Number of Tramadol Pills Taken All patients will be discharged with 28 pills of tramadol 50mg. At week 2 follow-up, number of tramadol pills taken will be reported. Week 2 post-treatment
Secondary Incidence of cutaneous complications Cutaneous complications between immediate fracture bracing and coaptation splints in the ER within the first 2 weeks of treatment will be reported Week 2 post-treatment
Secondary Score on PROMIS - Physical Function - Short Form 10b PROMIS consists of 10 statements/questions that are scored 1-5 each. The total range of score is 10-50; a higher score indicates less difficulty performing an activity. Week 1 post-treatment
Secondary Score on PROMIS - Physical Function - Short Form 10b PROMIS consists of 10 statements/questions that are scored 1-5 each. The total range of score is 10-50; a higher score indicates less difficulty performing an activity. Week 2 post-treatment
See also
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