Reverse Total Shoulder Arthroplasty Versus Nonoperative Treatment of 3 & 4-Part Proximal Humerus Fractures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Mayo Clinic
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Function as described by ASES score at 1 year follow-up.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Nonoperative Treatment
Subjects will have nonoperative treatment to treat proximal humerus fracture that is broken into 3 or 4 parts.
Intervention: Nonoperative Treatment (Other)
Operative Course for rTSA
Subjects will have shoulder replacement surgery to treat proximal humerus fracture that is broken into 3 or 4 parts.
Intervention: Reverse Total Shoulder Arthroplasty (rTSA) (Procedure)
Outcomes
Primary Outcomes
Function as described by ASES score at 1 year follow-up.
Time Frame: 2 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 Outcomes
No secondary outcomes reported
Investigators
Jonathan D. Barlow
Principal Investigator
Mayo Clinic