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NCT Number: NCT05118087

Comparison of Bracing With Co-aptation Splinting for the Initial Treatment of Acute Humeral Shaft Fractures: The COBRAS Trials

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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Key information

Conditions

Humeral Fractures Arm Injuries Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Winthrop Hospital, Garden City, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presenting to an emergency room or ICARE in the participating centers with an acute humeral shaft fracture
  • Age above 18 and skeletally mature
  • Isolated Injury
  • Treated non-operatively first 2 weeks

Exclusion criteria

  • Open fractures
  • Poly trauma
  • Injuries deemed operative by attending surgeon
  • Patients undergoing treatment for malignancy
  • Prisoners

Treatment and study plan

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.

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.

Primary outcomes

  1. Score on Pain Visual Analogue Scale (VAS)

    Time frame: Week 1 post-treatment

    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.

  2. Score on Pain Visual Analogue Scale (VAS)

    Time frame: Week 2 post-treatment

    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.

  3. Number of Tramadol Pills Taken

    Time frame: Week 1 post-treatment

    All patients will be discharged with 28 pills of tramadol 50mg. At week 1 follow-up, number of tramadol pills taken will be reported.

  4. Number of Tramadol Pills Taken

    Time frame: Week 2 post-treatment

    All patients will be discharged with 28 pills of tramadol 50mg. At week 2 follow-up, number of tramadol pills taken will be reported.

Secondary outcomes

  1. Incidence of cutaneous complications

    Time frame: Week 2 post-treatment

    Cutaneous complications between immediate fracture bracing and coaptation splints in the ER within the first 2 weeks of treatment will be reported

  2. Score on PROMIS - Physical Function - Short Form 10b

    Time frame: Week 1 post-treatment

    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.

  3. Score on PROMIS - Physical Function - Short Form 10b

    Time frame: Week 2 post-treatment

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 11, 2021
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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