Shoulder OsteoarthritisNCT05341518
Subscapularis Repair During Reverse Total Shoulder Arthroplasty
A study testing Subscapularis repair in people with Shoulder Osteoarthritis and Arthropathy Shoulder, run by Northwestern University at 2 sites in United States.
Trial summary
This multi-site study involving Northwestern Medicine, Beaumont Health, and Loyola Medicine seeks to answer the following question: do patients who undergo subscapularis (SSc) repair during reverse total shoulder arthroplasty (RSA) have better post-operative outcomes than patients who do not undergo SSc repair during… Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Shoulder Osteoarthritis, Arthropathy Shoulder
- What is being tested?
- Subscapularis repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jan 2023to Aug 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 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary RSA procedure with repairable (intact) SSc
- Operation will be performed by a participating surgeon using Zimmer Biomet Comprehensive Reverse Shoulder System implant
- Diagnosis with imaging of arthropathy with rotator cuff insufficiency
- Surgical approach: Deltopectoral
- Fluent English speakers/readers
Who cannot join
- Minor (<18 y/o)/vulnerable populations (pregnant women, prisoners, adults unable to consent)
- Revision surgery
- Oncologic surgery
- non-ZB CRSS implants
- Unrepairable SSc
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Loyola Medicine
Maywood, Illinois, 60153
Beaumont Health
Royal Oak, Michigan, 48073
About this study
Official title: Subscapularis Repair During Reverse Total Shoulder Arthroplasty: a Randomized Control Trial
This multi-site study involving Northwestern Medicine, Beaumont Health, and Loyola Medicine seeks to answer the following question: do patients who undergo subscapularis (SSc) repair during reverse total shoulder arthroplasty (RSA) have better post-operative outcomes than patients who do not undergo SSc repair during RSA? The investigators hypothesize that patients who do not undergo SSc repair during RSA have better post-operative outcomes than patients who undergo SSc repair during RSA. This study will address the controversy surrounding SSc repair during RSA via a multi-institutional randomized controlled trial that will compare clinical outcomes of patients who receive SSc repair during RSA to those who do not.
- Conditions
- Shoulder Osteoarthritis, Arthropathy Shoulder
- Being tested
- Subscapularis repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subscapularis repairProcedure or surgery
To complete reverse total shoulder arthroplasty, the surgeon must cut through the subscapularis muscle. In this arm of the study, the muscle will be repaired, rather than left to heal itself.
| Study group | Role | What they receive |
|---|---|---|
| Subscapularis repair | Experimental | Patients will undergo standard of care reverse total shoulder arthroplasty with subscapularis repair Receives: Procedure: Subscapularis repair |
| No repair | No intervention | Patients will undergo standard of care reverse total shoulder arthroplasty. The subscapularis will not be repaired. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Scored from 0 (worst shoulder condition) to 100 (best shoulder condition)
Measured: up to 12 months post-surgery
Secondary outcomes (3)
Internal Rotator (IR) Strength
IR at the side and supported IR at 90˚ scapation; percent of nonsurgical side
Measured: up to 12 months post-surgery
PROMIS Bank v1.1 - Pain Interference
PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population).
Measured: up to 12 months post-surgery
Shoulder Range of Motion
shoulder extension, flexion, internal rotation, abduction, adduction; percent of nonsurgical side
Measured: up to 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start2 Jan 2023
- Primary completionAug 2024 (estimated)
- Study completionAug 2025 (estimated)
Why it stopped: Participating sites failed to secure funding and study was not feasible at one site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Marra, Northwestern University
- Investigators
- Guido Marra, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341518
- Sponsor's protocol ID
- STU00215591
- Status last verified
- Mar 2024
- First submitted
- 18 Apr 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no participant data to share. No participants were enrolled.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subscapularis Repair During Reverse Total Shoulder Arthroplasty: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05341518
- Acronym / sponsor ID
- STU00215591
- Conditions
- Shoulder Osteoarthritis, Arthropathy Shoulder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Participating sites failed to secure funding and study was not feasible at one site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 22 Apr 2022 (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.
This multi-site study involving Northwestern Medicine, Beaumont Health, and Loyola Medicine seeks to answer the following question: do patients who undergo subscapularis (SSc) repair during reverse total shoulder arthroplasty (RSA) have better post-operative outcomes than patients who do not undergo SSc repair during RSA? The investigators hypothesize that patients who do not undergo SSc repair during RSA have better post-operative outcomes than patients who undergo SSc repair during RSA. This study will address the controversy surrounding SSc repair during RSA via a multi-institutional randomized controlled trial that will compare clinical outcomes of patients who receive SSc repair during RSA to those who do not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subscapularis repair | Experimental | Procedure: Subscapularis repairPatients will undergo standard of care reverse total shoulder arthroplasty with subscapularis repair |
| No repair | No intervention | –Patients will undergo standard of care reverse total shoulder arthroplasty. The subscapularis will not be repaired. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary RSA procedure with repairable (intact) SSc
- Operation will be performed by a participating surgeon using Zimmer Biomet Comprehensive Reverse Shoulder System implant
- Diagnosis with imaging of arthropathy with rotator cuff insufficiency
- Surgical approach: Deltopectoral
- Fluent English speakers/readers
Key exclusion criteria (5 listed)
- Minor (<18 y/o)/vulnerable populations (pregnant women, prisoners, adults unable to consent)
- Revision surgery
- Oncologic surgery
- non-ZB CRSS implants
- Unrepairable SSc
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 repairTo complete reverse total shoulder arthroplasty, the surgeon must cut through the subscapularis muscle. In this arm of the study, the muscle will be repaired, rather than left to heal itself. | Procedure or surgery | Subscapularis repair |
Primary outcome
The American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Time frame: up to 12 months post-surgery
Scored from 0 (worst shoulder condition) to 100 (best shoulder condition)
3 secondary outcomes
Internal Rotator (IR) Strength
Time frame: up to 12 months post-surgery
PROMIS Bank v1.1 - Pain Interference
Time frame: up to 12 months post-surgery
Shoulder Range of Motion
Time frame: up to 12 months post-surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No. There is no participant data to share. No participants were enrolled.
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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.
Guido Marra, MD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subscapularis repair in people with Shoulder Osteoarthritis and Arthropathy Shoulder, run by Northwestern University at 2 sites 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 5 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: withdrawn, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
The American Shoulder and Elbow Surgeons (ASES) Shoulder Score (time frame: up to 12 months post-surgery). 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 15 Mar 2024.