NCT04827277

TSA Versus RSA in Patients >75

A Prospective Randomized Clinical Trial Comparing Total Shoulder Arthroplasty vs Reverse Shoulder Arthroplasty in Patients >75 Years of Age

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Accepted

Summary

Total shoulder arthroplasty (TSA) has proven to be a predictable and successful operation for the treatment of symptomatic glenohumeral osteoarthritis (GHOA) with an intact rotator cuff. Results after TSA have not been as good in cases with rotator cuff dysfunction, however. Early glenoid loosening, shoulder pain and the need for revision surgery has been all associated with rotator cuff deficiency. Even in cases without tears, fatty infiltration of the rotator cuff has been associated with inferior outcomes in TSA. Advanced age has been shown to be associated with increased fatty infiltration of the rotator cuff in shoulders with primary osteoarthritis. Because of this, one may propose that surgeons should avoid the potential complications with TSA and perform RSA for patients with advanced age. It is thus the purpose of this study to evaluate the patient reported outcomes (PROs) of total shoulder arthroplasty (TSA) compared with reverse shoulder arthroplasty (RSA) in patients \>75 years of age

Conditions

• Total Shoulder Arthoplasty

Interventions

Type	Name	Description
PROCEDURE	Reverse Total Shoulder Replacement	Participants will be randomized to a reverse total shoulder replacement
PROCEDURE	Anatomic Total Shoulder Replacement	Participants will be randomized to an anatomic total shoulder replacement

Timeline

• Start date: 2021-04-15
• Primary completion: 2022-04-15
• Completion: 2022-04-15
• First posted: 2021-04-01
• Last updated: 2021-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study