Status:
COMPLETED
Does Early Elbow Motion Improve Patient Outcomes After Surgically Treated Elbow Fractures?
Lead Sponsor:
The Cooper Health System
Conditions:
Elbow Fracture
Range of Motion
Eligibility:
All Genders
18+ years
Phase:
NA
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 po...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05980312
Start Date
December 27 2019
End Date
April 20 2023
Last Update
August 7 2023
Active Locations (1)
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1
Cooper University Health Care
Camden, New Jersey, United States, 08103