TSA Versus RSA in Patients >75

NCT ID: NCT04827277

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2022-04-15

Brief Summary

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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

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Conditions

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Total Shoulder Arthoplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reverse total shoulder replacement

Participants will receive a reverse total shoulder arthroplasty

Group Type ACTIVE_COMPARATOR

Reverse Total Shoulder Replacement

Intervention Type PROCEDURE

Participants will be randomized to a reverse total shoulder replacement

Anatomic total shoulder replacement

Participants will receive an anatomic total shoulder arthroplasty

Group Type ACTIVE_COMPARATOR

Anatomic Total Shoulder Replacement

Intervention Type PROCEDURE

Participants will be randomized to an anatomic total shoulder replacement

Interventions

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Reverse Total Shoulder Replacement

Participants will be randomized to a reverse total shoulder replacement

Intervention Type PROCEDURE

Anatomic Total Shoulder Replacement

Participants will be randomized to an anatomic total shoulder replacement

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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JABB20D.949

Identifier Type: -

Identifier Source: org_study_id

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