By InvitationNot Applicable

Subscapularis-Sparing Total Shoulder Arthroplasty

United States50 participantsStarted 2021-01-29

Plain-language summary

The investigators purpose of this study are to perform a prospective clinical study to determine the following after subscapularis-sparing anatomic total shoulder arthroplasty performed for glenohumeral osteoarthritis: 1. patient-reported outcomes 2. shoulder motion and strength 3. rotator cuff integrity 4. the accuracy of component placement and the completeness of osteophyte removal

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients undergoing subscapularis-sparing anatomic total shoulder arthroplasty by the principal investigator at the University of Utah. Exclusion Criteria: * Patients unwilling to consent and comply with study procedures (i.e. follow up visits). * Patients under the age of 18. * Patients with contraindications to an anatomic total shoulder arthroplasty such as active infection, insufficient glenoid bone, damage to the rotator cuff, or a history of instability. * Patients with known prior shoulder arthroplasty. * Patients unable to undergo a magnetic resonance imaging study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score

Timeframe: Pre-operative

Patient-reported outcome (Simple Shoulder Test (SST))

Timeframe: Pre-operative

Patient-reported outcome (Visual Analogue Score (VAS))

Timeframe: Pre-operative

Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score

Timeframe: 6-weeks post-operative

Patient-reported outcome (Simple Shoulder Test (SST))

Timeframe: 6-weeks post-operative

Patient-reported outcome (Visual Analogue Score (VAS))

Timeframe: 6-weeks post-operative

Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score

Timeframe: 3-months post-operative

Trial details

NCT IDNCT07410650

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-01

View on ClinicalTrials.gov More Total Shoulder Arthroplasty trials

Plain-language summary

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score

Timeframe: Pre-operative

Patient-reported outcome (Simple Shoulder Test (SST))

Timeframe: Pre-operative

Patient-reported outcome (Visual Analogue Score (VAS))

Timeframe: Pre-operative

Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score

Timeframe: 6-weeks post-operative

Patient-reported outcome (Simple Shoulder Test (SST))

Timeframe: 6-weeks post-operative

Patient-reported outcome (Visual Analogue Score (VAS))

Timeframe: 6-weeks post-operative

Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score

Timeframe: 3-months post-operative