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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coaptation Splint | Active Comparator |
| |
| Sarmiento Brace | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Webril Padded Plaster Splint | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Score on PROMIS - Physical Function - Short Form 10b |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abhishek Ganta, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Winthrop Hospital | Garden City | New York | 11530 | United States | ||
| NYU Langone Health |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available upon reasonable request.
Immediately following publication. No end date.
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to abhishek.ganta@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| Pre-Fabricated Fracture Brace | Procedure | 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. |
|
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 |
| 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 |
| New York |
| New York |
| 10016 |
| United States |
| Jamaica Hospital Medical Center | Queens | New York | 11418 | United States |
| ID | Term |
|---|---|
| D006810 | Humeral Fractures |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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