TSA Versus RSA in Patients >75

Sponsor

Rothman Institute Orthopaedics (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04827277

Collaborator

(none)

108

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Total Shoulder Arthoplasty	Procedure: Reverse Total Shoulder Replacement Procedure: Anatomic Total Shoulder Replacement	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 15, 2021

Anticipated Primary Completion Date :

Apr 15, 2022

Anticipated Study Completion Date :

Apr 15, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 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)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rothman Institute Orthopaedics

ClinicalTrials.gov Identifier:

NCT04827277

Other Study ID Numbers:

JABB20D.949

First Posted:

Apr 1, 2021

Last Update Posted:

Apr 1, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Study Results

No Results Posted as of Apr 1, 2021