Total Shoulder ArthroplastyNCT07410650
Subscapularis-Sparing Total Shoulder Arthroplasty
An observational study of Total Shoulder Arthroplasty, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Total Shoulder Arthroplasty
- What is being tested?
- Subscapularis-Sparing Total Shoulder Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2021to Jan 2027
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing subscapularis-sparing anatomic total shoulder arthroplasty.
Who may be able to join
- Patients undergoing subscapularis-sparing anatomic total shoulder arthroplasty by the principal investigator at the University of Utah.
Who cannot join
- 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.
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
University of Utah Orthopedics
Salt Lake City, Utah, 84108
About this study
Official title: Subscapularis-Sparing Total Shoulder Arthroplasty: A Prospective Study
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:
- patient-reported outcomes
- shoulder motion and strength
- rotator cuff integrity
- 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.
- Conditions
- Total Shoulder Arthroplasty
- Being tested
- Subscapularis-Sparing Total Shoulder Arthroplasty
- Keywords
- Glenohumeral Osteoarthritis, Total Shoulder Arthroplasty, Subscapularis-Sparing, Prospective Study, Patient-Reported Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subscapularis-Sparing Total Shoulder ArthroplastyProcedure or surgery
A surgical technique for anatomic total shoulder arthroplasty that does not involve cutting any muscles or tendons.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pre-operative
Patient-reported outcome (Visual Analogue Score (VAS))
VAS pain score (0 no pain - 10 severe pain)
Measured: 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.
Measured: 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.
Measured: 6-weeks post-operative
Patient-reported outcome (Visual Analogue Score (VAS))
VAS pain score (0 no pain - 10 severe pain)
Measured: 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.
Measured: 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.
Measured: 3-months post-operative
Patient-reported outcome (Visual Analogue Score (VAS))
VAS pain score (0 no pain - 10 severe pain)
Measured: 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.
Measured: 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.
Measured: 1-year post-operative
Patient-reported outcome (Visual Analogue Score (VAS))
VAS pain score (0 no pain - 10 severe pain)
Measured: 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.
Measured: 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.
Measured: 2-years post-operative
Patient-reported outcome (Visual Analogue Score (VAS))
VAS pain score (0 no pain - 10 severe pain)
Measured: 2-years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start29 Jan 2021
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Shoulder ArthroplastyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Chalmers, University of Utah
- Investigators
- Peter Chalmers, M.D., Principal investigator, University of Utah Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410650
- Sponsor's protocol ID
- 137991
- Status last verified
- Sep 2026
- First submitted
- 5 Feb 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subscapularis-Sparing Total Shoulder Arthroplasty: A Prospective Study
- ClinicalTrials.gov ID
- NCT07410650
- Acronym / sponsor ID
- 137991
- Conditions
- Total Shoulder Arthroplasty
- Keywords
- Glenohumeral Osteoarthritis, Total Shoulder Arthroplasty, Subscapularis-Sparing, Prospective Study, Patient-Reported Outcomes
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 13 Feb 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 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:
- patient-reported outcomes
- shoulder motion and strength
- rotator cuff integrity
- the accuracy of component placement and the completeness of osteophyte removal
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing subscapularis-sparing anatomic total shoulder arthroplasty.
Key inclusion criteria (1 listed)
- Patients undergoing subscapularis-sparing anatomic total shoulder arthroplasty by the principal investigator at the University of Utah.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Subscapularis-Sparing Total Shoulder ArthroplastyA surgical technique for anatomic total shoulder arthroplasty that does not involve cutting any muscles or tendons. | Procedure or surgery | – |
Primary outcome
Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score
Time frame: Pre-operative
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.
Patient-reported outcome (Simple Shoulder Test (SST))
Time frame: Pre-operative
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.
Patient-reported outcome (Visual Analogue Score (VAS))
Time frame: Pre-operative
VAS pain score (0 no pain - 10 severe pain)
Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score
Time frame: 6-weeks post-operative
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.
Patient-reported outcome (Simple Shoulder Test (SST))
Time frame: 6-weeks post-operative
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.
Patient-reported outcome (Visual Analogue Score (VAS))
Time frame: 6-weeks post-operative
VAS pain score (0 no pain - 10 severe pain)
Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score
Time frame: 3-months post-operative
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.
Patient-reported outcome (Simple Shoulder Test (SST))
Time frame: 3-months post-operative
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.
Patient-reported outcome (Visual Analogue Score (VAS))
Time frame: 3-months post-operative
VAS pain score (0 no pain - 10 severe pain)
Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score
Time frame: 1-year post-operative
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.
Patient-reported outcome (Simple Shoulder Test (SST))
Time frame: 1-year post-operative
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.
Patient-reported outcome (Visual Analogue Score (VAS))
Time frame: 1-year post-operative
VAS pain score (0 no pain - 10 severe pain)
Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score
Time frame: 2-years post-operative
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.
Patient-reported outcome (Simple Shoulder Test (SST))
Time frame: 2-years post-operative
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.
Patient-reported outcome (Visual Analogue Score (VAS))
Time frame: 2-years post-operative
VAS pain score (0 no pain - 10 severe pain)
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 21 Sep 2026.
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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.
Peter Chalmers, M.D. principal investigator
University of Utah Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Shoulder Arthroplasty, run by University of Utah 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 1 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 21 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score (time frame: Pre-operative). The study lists 15 primary outcomes in all. 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 21 Sep 2026.