TSA Versus RSA in Patients >75

Not Applicable

• Conditions: Total Shoulder Arthoplasty
• Interventions: Procedure: Reverse Total Shoulder Replacement; Procedure: Anatomic Total Shoulder Replacement

• Registration Number: NCT04827277
• Lead Sponsor: Rothman Institute Orthopaedics

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-03-31
• Last Update Submitted: 2021-03-31
• Study First Posted: 2021-04-01
• Last Update Posted: 2021-04-01
• Study Start: 2021-04-15
• Primary Completion: 2022-04-15
• Study Completion: 2022-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• All patients (75 years of age) at the time of surgery
• Patient is willing to participate by complying with pre and postoperative visit requirements
• Patient is willing to consent for enrollment
• Patient has advanced imaging (CT or MRI) that demonstrates an intact rotator cuff

Exclusion Criteria

• Patients under the age of 75
• Need for any structural graft for repair of the shoulder during surgery
• Current infection of the proximal humerus or scapula
• Proximal humerus fracture
• Inadequate or malformed bone that precludes adequate support for prosthesis (B2, B3, C Glenoid morphology)
• Neuromuscular disorder that does not allow control of the shoulder joint
• Significant injury to the brachial plexus
• Diagnosis of inflammatory arthropathy
• Preoperative diagnosis of full thickness rotator cuff tear
• >Goutallier Stage 1 rotator cuff atrophy
• Prior shoulder arthroplasty
• Non-functioning deltoid muscle
• Patients who are known drug or alcohol abuser, or have a psychological disorder as defined by the DSM4 that could affect follow-up care
• Patient is a prisoner
• Patients who are currently involved in any personal injury litigation, or worker's compensation claims.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reverse total shoulder replacement	Reverse Total Shoulder Replacement	Participants will receive a reverse total shoulder arthroplasty
Anatomic total shoulder replacement	Anatomic Total Shoulder Replacement	Participants will receive an anatomic total shoulder arthroplasty

Primary Outcome Measures

Name	Time	Method
Postoperative satisfaction	2 years	Investigators will be measuring whether there is an increase in participants satisfaction after surgery as assessed by the American Shoulder and Elbow Score (ASES)
Postoperative Pain	2 years	Investigators will be measuring whether there is an increase in participants satisfaction after surgery as assessed by the Visual Analog Scale (VAS)
Postoperative Satisfaction	2 years	Investigators will be measuring whether there is an increase in participants satisfaction after surgery as assessed by the Simple Shoulder Test (SST)

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States