Arthropathy ShoulderNCT03727490
The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty
A study testing Repair and Standard Treatment in people with Arthropathy Shoulder, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The overall goal of the study is to determine if repairing the subscapularis tendon during primary reverse shoulder arthroplasty effects short-term patient outcomes. The study is a patient blinded randomized controlled trial that is currently enrolling. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthropathy Shoulder
- What is being tested?
- Repair and Standard Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults undergoing primary reverse shoulder arthroplasty
Who cannot join
- Adults without an intact subscapularis
- Inflammatory arthritis
- Revision surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University Department of Orthopaedic Surgery
St Louis, Missouri, 63110
About this study
The overall goal of the study is to determine if repairing the subscapularis tendon during primary reverse shoulder arthroplasty effects short-term patient outcomes. The study is a patient blinded randomized controlled trial that is currently enrolling.
- Conditions
- Arthropathy Shoulder
- Being tested
- Repair, Standard Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RepairOther
The subscapularis will be repaired.
Standard TreatmentOther
No repair will be performed
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | This group will have the subscapularis left un-repaired, which is the standard of care for our institution for reverse shoulder arthroplasty. Receives: Other: Standard Treatment |
| Study | Experimental | This group will have the subscapularis tendon repaired through a bone to bone repair that will add approximately 5 minutes to the surgical procedure. Receives: Other: Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons Score
Patient Reported Outcome
Measured: Two Years
Secondary outcomes (1)
Simple Shoulder Test
Patient Reported Outcome
Measured: Two Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start1 Dec 2018
- Primary completion1 Jan 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy ShoulderStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander W Aleem, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727490
- Sponsor's protocol ID
- 201611123
- Status last verified
- Dec 2025
- First submitted
- 30 Oct 2018
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT03727490
- Acronym / sponsor ID
- 201611123
- Conditions
- Arthropathy Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 1 Nov 2018 (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 overall goal of the study is to determine if repairing the subscapularis tendon during primary reverse shoulder arthroplasty effects short-term patient outcomes. The study is a patient blinded randomized controlled trial that is currently enrolling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Standard TreatmentThis group will have the subscapularis left un-repaired, which is the standard of care for our institution for reverse shoulder arthroplasty. |
| Study | Experimental | Other: RepairThis group will have the subscapularis tendon repaired through a bone to bone repair that will add approximately 5 minutes to the surgical procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults undergoing primary reverse shoulder arthroplasty
Key exclusion criteria (3 listed)
- Adults without an intact subscapularis
- Inflammatory arthritis
- Revision surgery
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 |
|---|---|---|
| RepairThe subscapularis will be repaired. | Other | Study |
| Standard TreatmentNo repair will be performed | Other | Control |
Primary outcome
American Shoulder and Elbow Surgeons Score
Time frame: Two Years
Patient Reported Outcome
1 secondary outcome
Simple Shoulder Test
Time frame: Two Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- 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. This study is not recruiting at the moment.
Alexander W Aleem, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repair and Standard Treatment in people with Arthropathy Shoulder, run by Washington University School of Medicine 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 3 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: finished, as of the sponsor's last update on 31 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
American Shoulder and Elbow Surgeons Score (time frame: Two Years). 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 31 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.