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TSA Versus RSA in Patients >75

NCT04827277 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2021-04-01

No results posted yet for this study

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

Interventions

PROCEDURE

Reverse Total Shoulder Replacement

Participants will be randomized to a reverse total shoulder replacement

PROCEDURE

Anatomic Total Shoulder Replacement

Participants will be randomized to an anatomic total shoulder replacement

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2022-04-15
Completion
2022-04-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04827277 on ClinicalTrials.gov