TSA Versus RSA in Patients >75
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ClinicalTrials.gov Identifier: NCT04827277 |
Recruitment Status :
Enrolling by invitation
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Total Shoulder Arthoplasty | Procedure: Reverse Total Shoulder Replacement Procedure: Anatomic Total Shoulder Replacement | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Reverse total shoulder replacement
Participants will receive a reverse total shoulder arthroplasty
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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
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Procedure: Anatomic Total Shoulder Replacement
Participants will be randomized to an anatomic total shoulder replacement |
- 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)
- 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)
- 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)

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Ages Eligible for Study: | 75 Years and older (Older Adult) |
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.

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
United States, Pennsylvania | |
Rothman Orthopaedic Institute | |
Philadelphia, Pennsylvania, United States, 19107 |
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 |
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 |