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NCT Number: NCT07584356

A Study Comparing Shoulder Replacement Techniques For Patients With Shoulder Arthritis And 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).

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Key information

Conditions

Shoulder Arthritis

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Shoulder arthritis
  • Intact rotator cuff
  • Glenoid retroversion less than 25°

Exclusion criteria

  • 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
  • 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

Treatment and study plan

aTSA

Procedure

Patients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo anatomic total shoulder arthroplasty (aTSA) procedure.

Other names: Anatomic total shoulder arthroplasty

rTSA

Procedure

Patients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo reverse total shoulder arthroplasty (rTSA) procedure.

Other names: Reverse total shoulder arthroplasty

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Visual Analog Scale (VAS) Score

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months

    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).

  2. Change in Single Assessment Numeric Evaluation (SANE) Score

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months

    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.

  3. Change in American Shoulder and Elbow Surgeons (ASES) Questionnaire score

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 24 months

    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.

  4. Change in Shoulder Subjective Value (SSV) Score

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months

    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.

  5. Change in Activities of Daily Living in External Rotation (ADLER) score

    Time frame: Baseline, 1 year

    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. Higher maximum scores indicate better functional ability.

  6. Change in Activities of Daily Living Includes Internal Rotation (ADLIR) score

    Time frame: Baseline, 1 year

    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. Higher maximum scores indicate better functional ability.

Study contacts

Contact information is provided by the study sponsor or research team.

Noelle M Drapeau, CCRP

CONTACT

[email protected]

507-266-6397

Xavier C Gendry

CONTACT

[email protected]

507-266-0687

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Randomized Trial Comparing Anatomic And Reverse Total Shoulder Replacement For Shoulder Arthritis With An Intact Rotator Cuff

Acronym: SOAR

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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