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Does Early Elbow Motion Improve Patient Outcomes After Surgically Treated Elbow Fractures?

Primary Purpose

Elbow Fracture, Range of Motion, Immobilization

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Splint Immobilization
Early Motion
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elbow Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects must have undergone operative treatment for an elbow fracture Operative indications for elbow fractures include: Type 13 humerus fractures including all subtypes, Type 2r1 radius fractures including all subtypes, Type 2u1 ulna fractures including all subtypes. Individuals over the age of 18 years old. Exclusion Criteria: Any patient who had not undergone operative treatment of an elbow fracture will be excluded. Patients who were not treated surgically by an orthopaedic surgeon or were treated outside of the study frame will be excluded. Individuals under the age of 18. Pregnant women. Patients admitted to the intensive care unit (ICU). Patients with a history of trauma or injury to the affected elbow will be excluded. Patients with extensive soft tissue injury of the elbow, which is defined as any injury that requires graft coverage, will be excluded. Non-English speaking patients will be excluded. Decisional-impaired patients will be excluded (as no substitute consent is requested).

Sites / Locations

  • Cooper University Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Immobilized

Early Range of Motion

Arm Description

Patients in the control group will be immobilized for 2 weeks and resume unrestricted motion once the splint is taken off.

Patients in the experimental group will start early motion immediately after surgery.

Outcomes

Primary Outcome Measures

ASES-E Scores
A standardized elbow evaluation was developed by the Research Committee of the American Shoulder and Elbow Surgeons 1 (ASES). This score allows the evaluation of elbow function independently from the underlying diagnosis.
HSS Elbow Score
The Hospital for Special Surgery (HSS) scoring system 31 consists of eight domains described as pain, function, sagittal range, muscle strength, flexion contracture, extension contracture, pronation, and supination.
Range of Motion

Secondary Outcome Measures

Full Information

First Posted
July 31, 2023
Last Updated
July 31, 2023
Sponsor
The Cooper Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05980312
Brief Title
Does Early Elbow Motion Improve Patient Outcomes After Surgically Treated Elbow Fractures?
Official Title
Early Range of Motion Versus Plaster Immobilization After Open Reduction Internal Fixation of Elbow Fractures: A Prospective, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 27, 2019 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
April 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cooper Health System

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 purpose of this study is to compare the safety and efficacy, defined as improved range of motion and functional outcome scores, of early elbow motion in the early (immediately post-op) and late postoperative periods (2 week post-op).
Detailed Description
A prospective randomized clinical trial will be performed. Patients over the age of 18 undergoing operative fixation of an elbow fracture by a Cooper orthopaedic surgeon will be considered for study inclusion. Patients who are under the age of 18, pregnant, admitted to the ICU, have a history of trauma/injury to the joint, or extensive soft tissue injury as determined by the treating orthopaedic surgeon will be excluded from study participation. All surgeons listed as co-investigators on this study have agreed to participate. Surgeons who may want to handle postop care differently despite randomization were not listed as co-investigators on this study. All patients will undergo operative fracture fixation of the elbow, which is standard of care. The decision for operative treatment will be made prior to study participation based on fracture classification and the discretion of the orthopaedic trauma team. There are discrete indications for operative treatment of elbow fractures in the orthopaedic literature. These guidelines are based upon the AO/OTA fracture classifications. Operative indications for elbow fractures include: type 13 humerus fractures including all subtypes, type 2r1 radius fractures including all subtypes, and type 2u1 ulna fractures including all subtypes. After this decision is made, the patient will be considered for study inclusion. There will be two treatment groups. The control group will be immobilized in a splint for 2 weeks and will be allowed to resume unrestricted motion at 2 weeks postop. The experimental group will be allowed to use unrestricted motion immediately after surgery. Both groups will be followed up postoperatively to monitor for pain, range of motion, and elbow function as well as the presence of complications. Once there is adequate pain control and if there are no complications, the patient will be discharged. All patients will be instructed to follow up with their surgeon within 2 weeks. If patients do not follow-up with the surgeon in 2 weeks time, the research team will call the patient to monitor clinical progress. At the time of follow-up, all patients will be recommended to go to physical therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elbow Fracture, Range of Motion, Immobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immobilized
Arm Type
Active Comparator
Arm Description
Patients in the control group will be immobilized for 2 weeks and resume unrestricted motion once the splint is taken off.
Arm Title
Early Range of Motion
Arm Type
Experimental
Arm Description
Patients in the experimental group will start early motion immediately after surgery.
Intervention Type
Other
Intervention Name(s)
Splint Immobilization
Intervention Description
Patients will be randomized to receive a splint following their surgical procedure.
Intervention Type
Other
Intervention Name(s)
Early Motion
Intervention Description
Patients will be randomized to receive no splint following their surgical procedure.
Primary Outcome Measure Information:
Title
ASES-E Scores
Description
A standardized elbow evaluation was developed by the Research Committee of the American Shoulder and Elbow Surgeons 1 (ASES). This score allows the evaluation of elbow function independently from the underlying diagnosis.
Time Frame
Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Title
HSS Elbow Score
Description
The Hospital for Special Surgery (HSS) scoring system 31 consists of eight domains described as pain, function, sagittal range, muscle strength, flexion contracture, extension contracture, pronation, and supination.
Time Frame
Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Title
Range of Motion
Time Frame
Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects must have undergone operative treatment for an elbow fracture Operative indications for elbow fractures include: Type 13 humerus fractures including all subtypes, Type 2r1 radius fractures including all subtypes, Type 2u1 ulna fractures including all subtypes. Individuals over the age of 18 years old. Exclusion Criteria: Any patient who had not undergone operative treatment of an elbow fracture will be excluded. Patients who were not treated surgically by an orthopaedic surgeon or were treated outside of the study frame will be excluded. Individuals under the age of 18. Pregnant women. Patients admitted to the intensive care unit (ICU). Patients with a history of trauma or injury to the affected elbow will be excluded. Patients with extensive soft tissue injury of the elbow, which is defined as any injury that requires graft coverage, will be excluded. Non-English speaking patients will be excluded. Decisional-impaired patients will be excluded (as no substitute consent is requested).
Facility Information:
Facility Name
Cooper University Health Care
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Does Early Elbow Motion Improve Patient Outcomes After Surgically Treated Elbow Fractures?

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