TSA Versus RSA in Patients >75

NCT04827277 | Unknown FDA Device

• 1 other identifier: JABB20D.949
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Conditions

Total Shoulder Arthoplasty

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Reverse total shoulder replacement

ACTIVE COMPARATOR

Participants will receive a reverse total shoulder arthroplasty

Procedure: Reverse Total Shoulder Replacement

Anatomic total shoulder replacement

ACTIVE COMPARATOR

Participants will receive an anatomic total shoulder arthroplasty

Procedure: Anatomic Total Shoulder Replacement

Interventions

Reverse Total Shoulder Replacement PROCEDURE

Participants will be randomized to a reverse total shoulder replacement

Reverse total shoulder replacement

Anatomic Total Shoulder Replacement PROCEDURE

Participants will be randomized to an anatomic total shoulder replacement

Anatomic total shoulder replacement

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 1, 2021
• Study Start: April 15, 2021
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

US (1)