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Enrolling by invitationNCT07410650Updated Sep 21, 2026

Subscapularis-Sparing Total Shoulder Arthroplasty

An observational study in Total Shoulder Arthroplasty, sponsored by University of Utah. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by University of Utah · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 90 Years
Sex
All
01

Study 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
Read the detailed description

Anatomic total shoulder arthroplasty (TSA) provides excellent pain relief and restoration of shoulder function in the setting of glenohumeral osteoarthritis. However, the surgical approach requires the subscapularis to be cut and repaired, via either a lesser tuberosity osteotomy, a subscapularis tenotomy, or a subscapularis peel.This repair must be protected post-operatively, even with a lesser tuberosity osteotomy, or it can displace or fail to heal, which complicates rehabilitation. Failure of the subscapularis repair occurs in 10-25% of patients. Failure of the subscapularis repair is often devastating for shoulder function and often requires revision to a reverse total shoulder arthroplasty. Even when muscle-tendon-bone healing does occur there is post-operative atrophy of the subscapularis that may compromise function and strength. Atrophy of the subscapularis may lead to imbalance of the rotator cuff musculature, leading to subluxation and glenoid loosening. While there have been attempts to develop approaches that do not involve cutting the subscapularis, they have been plagued by osteophyte retention, component malposition, damage to the deltoid, or damage to the supraspinatus.

The principal investigator has spent four years developing a technique for anatomic total shoulder arthroplasty that does not involve cutting any muscles or tendons and has been through the learning curve with this technique by completing >20 cases and at least as many cadaver surgeries during that time period. This technique has been designed to avoid the potential issues with prior attempts and utilizes purpose designed instrumentation and retractors.

02

Conditions studied

  • Total Shoulder Arthroplasty

Keywords

  • Glenohumeral Osteoarthritis
  • Total Shoulder Arthroplasty
  • Subscapularis-Sparing
  • Prospective Study
  • Patient-Reported Outcomes
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing subscapularis-sparing anatomic total shoulder arthroplasty.

Inclusion criteria

  • Patients undergoing subscapularis-sparing anatomic total shoulder arthroplasty by the principal investigator at the University of Utah.

Exclusion criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • ProcedureSubscapularis-Sparing Total Shoulder Arthroplasty

    A surgical technique for anatomic total shoulder arthroplasty that does not involve cutting any muscles or tendons.

05

What researchers measure

Primary outcomes

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

    Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.

    Time frame: Pre-operative

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

    There are 12 shoulder specific questions which the patient answers "yes" or "no". The questions ask about strength, function and range of motion. To score the test, divide the number of "yes" answers by the total number of questions answered and then multiply by 100. 0% is the worst score to 100% being the best score.

    Time frame: Pre-operative

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

    VAS pain score (0 no pain - 10 severe pain)

    Time frame: Pre-operative

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

    Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.

    Time frame: 6-weeks post-operative

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

    There are 12 shoulder specific questions which the patient answers "yes" or "no". The questions ask about strength, function and range of motion. To score the test, divide the number of "yes" answers by the total number of questions answered and then multiply by 100. 0% is the worst score to 100% being the best score.

    Time frame: 6-weeks post-operative

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

    VAS pain score (0 no pain - 10 severe pain)

    Time frame: 6-weeks post-operative

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

    Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.

    Time frame: 3-months post-operative

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

    There are 12 shoulder specific questions which the patient answers "yes" or "no". The questions ask about strength, function and range of motion. To score the test, divide the number of "yes" answers by the total number of questions answered and then multiply by 100. 0% is the worst score to 100% being the best score.

    Time frame: 3-months post-operative

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

    VAS pain score (0 no pain - 10 severe pain)

    Time frame: 3-months post-operative

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

    Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.

    Time frame: 1-year post-operative

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

    There are 12 shoulder specific questions which the patient answers "yes" or "no". The questions ask about strength, function and range of motion. To score the test, divide the number of "yes" answers by the total number of questions answered and then multiply by 100. 0% is the worst score to 100% being the best score.

    Time frame: 1-year post-operative

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

    VAS pain score (0 no pain - 10 severe pain)

    Time frame: 1-year post-operative

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

    Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.

    Time frame: 2-years post-operative

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

    There are 12 shoulder specific questions which the patient answers "yes" or "no". The questions ask about strength, function and range of motion. To score the test, divide the number of "yes" answers by the total number of questions answered and then multiply by 100. 0% is the worst score to 100% being the best score.

    Time frame: 2-years post-operative

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

    VAS pain score (0 no pain - 10 severe pain)

    Time frame: 2-years post-operative

06

Study locations

1 site
  • University of Utah Orthopedics
    Salt Lake City, Utah 84108, United States
07

Registry details

Key details

Study ID
NCT07410650
Lead sponsor
University of Utah
Responsible party
Peter Chalmers (Principle Investigator, University of Utah) — Principal investigator
First posted
Feb 13, 2026
Start date
Jan 29, 2021
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Peter Chalmers, M.D.
principal investigator · University of Utah Orthopaedics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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