NCT07410650

Brief 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. 1.patient-reported outcomes
  2. 2.shoulder motion and strength
  3. 3.rotator cuff integrity
  4. 4.the accuracy of component placement and the completeness of osteophyte removal

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jan 2021Jan 2027

Study Start

First participant enrolled

January 29, 2021

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

5.9 years

First QC Date

February 5, 2026

Last Update Submit

February 12, 2026

Conditions

Keywords

Glenohumeral OsteoarthritisTotal Shoulder ArthroplastySubscapularis-SparingProspective StudyPatient-Reported Outcomes

Outcome Measures

Primary Outcomes (15)

  • 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.

    Pre-operative

  • 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.

    Pre-operative

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

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

    Pre-operative

  • 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.

    6-weeks post-operative

  • 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.

    6-weeks post-operative

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

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

    6-weeks post-operative

  • 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.

    3-months post-operative

  • 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.

    3-months post-operative

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

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

    3-months post-operative

  • 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.

    1-year post-operative

  • 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.

    1-year post-operative

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

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

    1-year post-operative

  • 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.

    2-years post-operative

  • 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.

    2-years post-operative

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

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

    2-years post-operative

Interventions

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing subscapularis-sparing anatomic total shoulder arthroplasty.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Orthopedics

Salt Lake City, Utah, 84108, United States

Location

Study Officials

  • Peter Chalmers, M.D.

    University of Utah Orthopaedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 13, 2026

Study Start

January 29, 2021

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations