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TSA Versus RSA in Patients >75

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04827277
Recruitment Status : Enrolling by invitation
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : April 15, 2021
Estimated Primary Completion Date : April 15, 2022
Estimated Study Completion Date : April 15, 2022
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Postoperative satisfaction [ Time Frame: 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)

  2. Postoperative Satisfaction [ Time Frame: 2 years ]
    Investigators will be measuring whether there is an increase in participants satisfaction after surgery as assessed by the Simple Shoulder Test (SST)

  3. Postoperative Pain [ Time Frame: 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
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04827277


Locations
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United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
More Information
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04827277    
Other Study ID Numbers: JABB20D.949
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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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