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

Primary Purpose

Humeral Fractures

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Webril Padded Plaster Splint
Pre-Fabricated Fracture Brace
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Humeral Fractures focused on measuring Sarmiento Brace, Coaptation Splint

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Winthrop Hospital
  • NYU Langone HealthRecruiting
  • Jamaica Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Coaptation Splint

Sarmiento Brace

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
November 1, 2021
Last Updated
July 17, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT05118087
Brief Title
Comparison of Bracing With Co-aptation Splinting for the Initial Treatment of Acute Humeral Shaft Fractures: The COBRAS Trials
Official Title
Comparison of Bracing With Co-aptation Splinting for the Initial Treatment of Acute Humeral Shaft Fractures: The COBRAS Trials
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
July 6, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humeral Fractures
Keywords
Sarmiento Brace, Coaptation Splint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coaptation Splint
Arm Type
Active Comparator
Arm Title
Sarmiento Brace
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Webril Padded Plaster Splint
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pre-Fabricated Fracture Brace
Intervention Description
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 Outcome Measure Information:
Title
Score on Pain Visual Analogue Scale (VAS)
Description
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.
Time Frame
Week 1 post-treatment
Title
Score on Pain Visual Analogue Scale (VAS)
Description
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.
Time Frame
Week 2 post-treatment
Title
Number of Tramadol Pills Taken
Description
All patients will be discharged with 28 pills of tramadol 50mg. At week 1 follow-up, number of tramadol pills taken will be reported.
Time Frame
Week 1 post-treatment
Title
Number of Tramadol Pills Taken
Description
All patients will be discharged with 28 pills of tramadol 50mg. At week 2 follow-up, number of tramadol pills taken will be reported.
Time Frame
Week 2 post-treatment
Secondary Outcome Measure Information:
Title
Incidence of cutaneous complications
Description
Cutaneous complications between immediate fracture bracing and coaptation splints in the ER within the first 2 weeks of treatment will be reported
Time Frame
Week 2 post-treatment
Title
Score on PROMIS - Physical Function - Short Form 10b
Description
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.
Time Frame
Week 1 post-treatment
Title
Score on PROMIS - Physical Function - Short Form 10b
Description
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.
Time Frame
Week 2 post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abhishek Ganta, MD
Phone
718-206-6923
Email
abhishek.ganta@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhishek Ganta, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Winthrop Hospital
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meelan Patel, MD
First Name & Middle Initial & Last Name & Degree
Meelan Patel, MD
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abhishek Ganta
Email
abhishek.ganta@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Abhishek Ganta, MD
Facility Name
Jamaica Hospital Medical Center
City
Queens
State/Province
New York
ZIP/Postal Code
11418
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjit Konda, MD
Email
Sanjit.Konda@nyumc.org
First Name & Middle Initial & Last Name & Degree
Sanjit Konda, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available upon reasonable request.
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
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.

Learn more about this trial

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

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