Back to resultsRSA vs. Nonop for 3 & 4-Part Proximal Humerus Fractures
Primary Purpose
Humerus Fracture, Humerus, Shoulder Fractures
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reverse Total Shoulder Arthroplasty (rTSA)
Nonoperative Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Humerus Fracture
Eligibility Criteria
Inclusion criteria
- Displaced 3- and 4-part proximal humerus fractures.
- Age greater than or equal to 65 years old.
Exclusion Criteria
- Less than 65 years old.
- Medical comorbidities precluding surgical treatment or anesthesia
- Dementia or inability to provide adequate follow up.
- Pathologic fractures
- Open fractures
- Associated injuries: fracture dislocations, multiple or complex injuries of the 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
Other
Other
Arm Label
Nonoperative Treatment
Operative Course for rTSA
Arm Description
Subjects will have nonoperative treatment to treat proximal humerus fracture that is broken into 3 or 4 parts.
Subjects will have shoulder replacement surgery to treat proximal humerus fracture that is broken into 3 or 4 parts.
Outcomes
Primary Outcome Measures
Function as described by ASES score at 1 year follow-up.
The American Shoulder and Elbow Surgeons (ASES) score is a well-validated, patient-reported outcome measure used by shoulder and elbow surgeons. The score ranges from 0-100 with 100 signifying the best outcome. Half of the score correlates to pain and half to function, both on a 0-50 scale where higher is again considered a better outcome. The pain portion is tabulated by taking the patient's response on a visual analogue scale (0 to 10 scale where 0 represent no pain and 10 represents worst pain imaginable), subtracting it from 10, and then multiplying by 5. The function score is tabulated by taking the patient's response on 10 questions rated on an ordinal scale from 0-3 and then multiplying the cumulative score by 5/3.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03599336
Brief Title
RSA vs. Nonop for 3 & 4-Part Proximal Humerus Fractures
Official Title
Reverse Total Shoulder Arthroplasty Versus Nonoperative Treatment of 3 & 4-Part Proximal Humerus Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Slower than expected enrollment.
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
October 29, 2020 (Actual)
Study Completion Date
October 29, 2020 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
There is currently no consensus amongst orthopedic specialists on the best way to treat 3- and 4-part proximal humerus fractures. No surgery and surgery with a type of shoulder replacement called a reverse total shoulder arthroplasty are two options that many orthopedists use. This study is being performed to evaluate the differences in short- and long-term pain and functional outcomes between patients who are treated with these two different options.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humerus Fracture, Humerus, Shoulder Fractures, Shoulder Arthropathy Associated With Other Conditions, Arthropathy Shoulder, Shoulder Injury, Arthropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nonoperative Treatment
Arm Type
Other
Arm Description
Subjects will have nonoperative treatment to treat proximal humerus fracture that is broken into 3 or 4 parts.
Arm Title
Operative Course for rTSA
Arm Type
Other
Arm Description
Subjects will have shoulder replacement surgery to treat proximal humerus fracture that is broken into 3 or 4 parts.
Intervention Type
Procedure
Intervention Name(s)
Reverse Total Shoulder Arthroplasty (rTSA)
Intervention Description
Surgical management will include placement of fracture specific, cemented reverse total shoulder arthroplasty components as per standard surgical care and routine postoperative rehabilitation.
Intervention Type
Other
Intervention Name(s)
Nonoperative Treatment
Intervention Description
Subjects allocated to the nonoperative treatment arm will maintain sling immobilization for 3 weeks. The sling will be removed for elbow, wrist and hand range of motion (ROM), hygiene, and dressing only. At 3 weeks passive ROM in external rotation (ER) and forward elevation (FE) will be added. At 6 weeks from injury, the sling will be removed and stretching in all planes will be allowed. Use of the arm will be up to a fork/knife/toothbrush only. At 3 months from injury, strengthening will be added. Supervised physical therapy will be offered to patients for use at their discretion, as is current practice.
Primary Outcome Measure Information:
Title
Function as described by ASES score at 1 year follow-up.
Description
The American Shoulder and Elbow Surgeons (ASES) score is a well-validated, patient-reported outcome measure used by shoulder and elbow surgeons. The score ranges from 0-100 with 100 signifying the best outcome. Half of the score correlates to pain and half to function, both on a 0-50 scale where higher is again considered a better outcome. The pain portion is tabulated by taking the patient's response on a visual analogue scale (0 to 10 scale where 0 represent no pain and 10 represents worst pain imaginable), subtracting it from 10, and then multiplying by 5. The function score is tabulated by taking the patient's response on 10 questions rated on an ordinal scale from 0-3 and then multiplying the cumulative score by 5/3.
Time Frame
2 year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Displaced 3- and 4-part proximal humerus fractures.
Age greater than or equal to 65 years old.
Exclusion Criteria
Less than 65 years old.
Medical comorbidities precluding surgical treatment or anesthesia
Dementia or inability to provide adequate follow up.
Pathologic fractures
Open fractures
Associated injuries: fracture dislocations, multiple or complex injuries of the ipsilateral limb, complete brachial plexopathy, vascular injury and polytrauma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan D Barlow
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
Citations:
PubMed Identifier
35727196
Citation
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
RSA vs. Nonop for 3 & 4-Part Proximal Humerus Fractures
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