Back to resultsReverse Total Shoulder Arthroplasty Versus Open Reduction Internal Fixation of 3&4 Part Proximal Humerus Fractures
Primary Purpose
Closed Fracture Proximal Humerus, Four Part
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fracture repair
Fracture repair with joint replacement
Sponsored by
About this trial
This is an interventional treatment trial for Closed Fracture Proximal Humerus, Four Part
Eligibility Criteria
Inclusion
- Neer 3 and 4-part proximal humerus fractures.
- Age greater than and equal to 70 years old.
- Functional deltoid musculature (axillary nerve intact).
Exclusion
- Less than 70 years old.
- Dementia or inability to provide adequate follow up.
- Associated injuries: injuries of ipsilateral limb, complete brachial plexopathy, vascular injury and polytrauma.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Open Reduction Internal Fixation Proximal Humerus
Reverse Total Shoulder Arthroplasty
Arm Description
The patients randomized into the ORIF group will receive standard surgical treatment of their proximal humerus fracture with a proximal humeral locking plate.
The patients randomized into the RTSA group will receive standard surgical treatment of their proximal humeral fracture with a Reverse Total Shoulder Arthroplasty.
Outcomes
Primary Outcome Measures
To measure the change using the chi-square tests for lowering the pain score of the patients
threshold of statistical significance will be set at α = 0.05.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02597972
Brief Title
Reverse Total Shoulder Arthroplasty Versus Open Reduction Internal Fixation of 3&4 Part Proximal Humerus Fractures
Official Title
Reverse Total Shoulder Arthroplasty Versus Open Reduction Internal Fixation of 3 &Amp; 4-Part Proximal Humerus Fractures: A Randomized Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
project opened under new PI
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 17, 2018 (Actual)
Study Completion Date
December 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Will patients who suffer complex humerus fractures have better functional outcomes and less implant failure with shoulder replacement (reverse total shoulder arthroplasty, RTSA) compared to shoulder repair (open reduction and internal fixation, ORIF)?
Detailed Description
The purpose of this study is to compare validated clinical and functional outcomes between patients who acutely present with 3 and 4-part proximal humerus fractures treated with either ORIF or RTSA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed Fracture Proximal Humerus, Four Part
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Reduction Internal Fixation Proximal Humerus
Arm Type
Active Comparator
Arm Description
The patients randomized into the ORIF group will receive standard surgical treatment of their proximal humerus fracture with a proximal humeral locking plate.
Arm Title
Reverse Total Shoulder Arthroplasty
Arm Type
Active Comparator
Arm Description
The patients randomized into the RTSA group will receive standard surgical treatment of their proximal humeral fracture with a Reverse Total Shoulder Arthroplasty.
Intervention Type
Procedure
Intervention Name(s)
Fracture repair
Intervention Type
Procedure
Intervention Name(s)
Fracture repair with joint replacement
Primary Outcome Measure Information:
Title
To measure the change using the chi-square tests for lowering the pain score of the patients
Description
threshold of statistical significance will be set at α = 0.05.
Time Frame
base line to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion
Neer 3 and 4-part proximal humerus fractures.
Age greater than and equal to 70 years old.
Functional deltoid musculature (axillary nerve intact).
Exclusion
Less than 70 years old.
Dementia or inability to provide adequate follow up.
Associated injuries: injuries of ipsilateral limb, complete brachial plexopathy, vascular injury and polytrauma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaquin Sanchez-Sotelo, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Reverse Total Shoulder Arthroplasty Versus Open Reduction Internal Fixation of 3&4 Part Proximal Humerus Fractures
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