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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Total Shoulder Arthoplasty
• Intervention / Treatment: Procedure: Reverse Total Shoulder Replacement; Procedure: Anatomic Total Shoulder Replacement

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Reverse total shoulder replacement; Participants will receive a reverse total shoulder arthroplasty	Procedure: Reverse Total Shoulder Replacement; Participants will be randomized to a reverse total shoulder replacement
ACTIVE_COMPARATOR: Anatomic total shoulder replacement; Participants will receive an anatomic total shoulder arthroplasty	Procedure: Anatomic Total Shoulder Replacement; Participants will be randomized to an anatomic total shoulder replacement

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 15, 2021
• Primary Completion (ANTICIPATED): April 15, 2022
• Study Completion (ANTICIPATED): April 15, 2022

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (ACTUAL): April 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: JABB20D.949

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes