RSA vs. Nonop for 3 & 4-Part Proximal Humerus Fractures

Not Applicable

Terminated

• Conditions: Shoulder Fractures; Shoulder Arthropathy Associated With Other Conditions; Humerus Fracture; Arthropathy Shoulder; Shoulder Injury; Humerus; Arthropathy
• Interventions: Other: Nonoperative Treatment; Procedure: Reverse Total Shoulder Arthroplasty (rTSA)

• Registration Number: NCT03599336
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-30
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-07-26
• Study Start: 2018-08-01
• Primary Completion: 2020-10-29
• Study Completion: 2020-10-29
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nonoperative Treatment	Nonoperative Treatment	Subjects will have nonoperative treatment to treat proximal humerus fracture that is broken into 3 or 4 parts.
Operative Course for rTSA	Reverse Total Shoulder Arthroplasty (rTSA)	Subjects will have shoulder replacement surgery to treat proximal humerus fracture that is broken into 3 or 4 parts.

Primary Outcome Measures

Name	Time	Method
Function as described by ASES score at 1 year follow-up.	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States