Shoulder ArthritisSOARNCT07584356
A Study Comparing Shoulder Replacement Techniques For Patients With Shoulder Arthritis And An Intact Rotator Cuff
A study testing aTSA and rTSA in people with Shoulder Arthritis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine if patients undergoing anatomic total shoulder arthroplasty (aTSA) will have improved patient reported outcome scores at 1 year compared to those undergoing reverse total shoulder arthroplasty (rTSA). Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Shoulder Arthritis
- What is being tested?
- aTSA and rTSA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Shoulder arthritis
- Intact rotator cuff
- Glenoid retroversion less than 25°
Who cannot join
- Rotator cuff insufficiency
- Fracture deformity/sequelae
- Severe glenoid deformity (C glenoid, severe A2, B2 glenoid)
- Current or previous infection of shoulder
- Previous acromion fracture (not os acromiale)
- Brachial plexopathy
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- Axillary neuropathy
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
- Medical conditions that would make 2 years follow up unlikely
- Non-English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Lucille I Anderson, CCRP, 507-538-5627, anderson.luci@mayo.edu
Jonathan D. Barlow, MD
About this study
Official title: A Randomized Trial Comparing Anatomic And Reverse Total Shoulder Replacement For Shoulder Arthritis With An Intact Rotator Cuff
The purpose of this study is to determine if patients undergoing anatomic total shoulder arthroplasty (aTSA) will have improved patient reported outcome scores at 1 year compared to those undergoing reverse total shoulder arthroplasty (rTSA).
- Conditions
- Shoulder Arthritis
- Being tested
- aTSA, rTSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aTSAProcedure or surgery
Also called Anatomic total shoulder arthroplasty
Patients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo anatomic total shoulder arthroplasty (aTSA) procedure.
rTSAProcedure or surgery
Also called Reverse total shoulder arthroplasty
Patients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo reverse total shoulder arthroplasty (rTSA) procedure.
| Study group | Role | What they receive |
|---|---|---|
| Anatomic total shoulder arthroplasty (aTSA) | Other | Not described Receives: Procedure: aTSA |
| Reverse total shoulder arthroplasty (rTSA) | Other | Not described Receives: Procedure: rTSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons (ASES) Questionnaire score
The American Shoulder and Elbow Surgeons (ASES) score is a self-report survey consisting of a pain scale and activities of daily living section. Total scores range from 0 to 100, where higher scores indicate better shoulder function and less pain.
Measured: 1 year
Secondary outcomes (6)
Change in Visual Analog Scale (VAS) Score
The Visual Analog Scale (VAS) is a 1 item self-report survey that asks the subject to rate the level of pain on a scale of 0 (no pain) - 10 (worst imaginable pain).
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
Change in Single Assessment Numeric Evaluation (SANE) Score
The Single Assessment Numeric Evaluation (SANE) is a 2 item self-report survey that asks subjects to rate the percent of normal range on both the affected joint/region and the opposite joint/region. Scores range from 0% - 100%, with 100% indicating normal range.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
Change in American Shoulder and Elbow Surgeons (ASES) Questionnaire score
The American Shoulder and Elbow Surgeons (ASES) score is a self-report survey consisting of a pain scale and activities of daily living section. Total scores range from 0 to 100, where higher scores indicate better shoulder function and less pain.
Measured: Baseline, 6 weeks, 3 months, 6 months, 24 months
Change in Shoulder Subjective Value (SSV) Score
The Subjective Shoulder Value (SSV) is 1 item self-report survey that asks subjects to rate their overall shoulder function as a percentage of a "normal" (100%) shoulder.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
Change in Activities of Daily Living in External Rotation (ADLER) score
The Activities of Daily Living in External Rotation (ADLER) is a self-report tool used to assess shoulder disability by quantifying a patient's ability to perform 10 specific daily tasks requiring active external rotation. Overall scores range from 0 to 30. Higher maximum scores indicate better functional ability.
Measured: Baseline, 1 year
Change in Activities of Daily Living Includes Internal Rotation (ADLIR) score
The Activities of Daily Living Includes Internal Rotation (ADLIR) is a self-report tool used to assess shoulder disability by quantifying a patient's ability to perform 9 specific daily tasks requiring active internal rotation. Overall scores range from 14 to 100. Higher maximum scores indicate better functional ability.
Measured: Baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start5 May 2026
- Primary completionJul 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthritisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan D. Barlow, Mayo Clinic
- Investigators
- Jonathan D. Barlow, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584356
- Sponsor's protocol ID
- 26-002449
- Acronym
- SOAR
- Status last verified
- Aug 2026
- First submitted
- 7 May 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Anatomic And Reverse Total Shoulder Replacement For Shoulder Arthritis With An Intact Rotator Cuff
- ClinicalTrials.gov ID
- NCT07584356
- Acronym / sponsor ID
- SOAR / 26-002449
- Conditions
- Shoulder Arthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 May 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if patients undergoing anatomic total shoulder arthroplasty (aTSA) will have improved patient reported outcome scores at 1 year compared to those undergoing reverse total shoulder arthroplasty (rTSA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatomic total shoulder arthroplasty (aTSA) | Other | Procedure: aTSA |
| Reverse total shoulder arthroplasty (rTSA) | Other | Procedure: rTSA |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Shoulder arthritis
- Intact rotator cuff
- Glenoid retroversion less than 25°
Key exclusion criteria (11 listed)
- Rotator cuff insufficiency
- Fracture deformity/sequelae
- Severe glenoid deformity (C glenoid, severe A2, B2 glenoid)
- Current or previous infection of shoulder
- Previous acromion fracture (not os acromiale)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aTSAAlso: Anatomic total shoulder arthroplastyPatients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo anatomic total shoulder arthroplasty (aTSA) procedure. | Procedure or surgery | Anatomic total shoulder arthroplasty (aTSA) |
| rTSAAlso: Reverse total shoulder arthroplastyPatients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo reverse total shoulder arthroplasty (rTSA) procedure. | Procedure or surgery | Reverse total shoulder arthroplasty (rTSA) |
Primary outcome
American Shoulder and Elbow Surgeons (ASES) Questionnaire score
Time frame: 1 year
The American Shoulder and Elbow Surgeons (ASES) score is a self-report survey consisting of a pain scale and activities of daily living section. Total scores range from 0 to 100, where higher scores indicate better shoulder function and less pain.
6 secondary outcomes
Change in Visual Analog Scale (VAS) Score
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
Change in Single Assessment Numeric Evaluation (SANE) Score
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
Change in American Shoulder and Elbow Surgeons (ASES) Questionnaire score
Time frame: Baseline, 6 weeks, 3 months, 6 months, 24 months
Change in Shoulder Subjective Value (SSV) Score
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
Change in Activities of Daily Living in External Rotation (ADLER) score
Time frame: Baseline, 1 year
Change in Activities of Daily Living Includes Internal Rotation (ADLIR) score
Time frame: Baseline, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan D. Barlow, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aTSA and rTSA in people with Shoulder Arthritis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucille I Anderson, CCRP (507-538-5627, anderson.luci@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Surgeons (ASES) Questionnaire score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.