Shoulder ArthroplastySICDRNCT06754150
Shoulder Innovations Clinical Data Registry
An observational study of Shoulder Arthroplasty, run by Shoulder Innovations at 10 sites in United States.
Trial summary
The goal of this multi-center observational study is to collect long-term clinical outcome information for anatomic and reverse total shoulder arthroplasty (shoulder replacement). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Arthroplasty
- How many people
- 2,500 participants
- Where
- 10 sitesUnited States
- Study dates
- 23 Oct 2024to Dec 2039
- How long will I take part?
- 10 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (at least 18 years of age) of any gender undergoing a shoulder arthroplasty for any diagnosis/condition with at least one SI Total Shoulder System component enrolled at participating sites
Who may be able to join
- At least 18 years of age.
- Plan to receive or has received a shoulder arthroplasty surgical procedure, with a minimum of one implanted Shoulder Innovations (SI) device component and be willing and able to complete post-operative visits as long as at least one SI device component remains implanted.
- Able to provide informed consent prior to enrollment in the study (unless a waiver has been obtained).
- Agree to and be able to consistently answer the specified Patient Reported Outcome Measures (PROM) pre-operatively and at each of the post-operative visits without the use of a translator.
- Willing and able to comply with the requirements of the study protocol
Who cannot join
- Participation in a clinical trial of an investigational drug or device that would confound the results of this trial. Participation in another observational registry is allowed provided there are no conflicting requirements to this trial.
- Incarceration.
- Any conditions, co-morbidities, restrictions, or obligations that would prohibit them from complying with the requirements of this study protocol.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
St. Vincent's Orthopedics
Birmingham, Alabama, 35205
Tara Thomas, 205-572-4073, tara@stvortho.com
David Adkison, MD
- Enrolling by invitation
St. Vincent's Orthopedics
Birmingham, Alabama, 35205
- Recruiting
Connolly Orthopedics
Bradenton, Florida, 34208
Alexis Connolly, MSN, APRN, FNP-BC, (941) 757-3521, alexisc@connollyortho.com
Brendon Connolly, MD
- Recruiting
Western Orthopaedics
Denver, Colorado, 80222
Mallory Boyd, 303-253-7353, Mallory.Boyd2@hcahealthone.com
Libby Mauter, 303-253-7378, Libby.Mauter@hcahealthcare.com
- Enrolling by invitation
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
- Recruiting
CAO Southern Maryland Orthopaedics
Leonardtown, Maryland, 20650
Nicole Hanson, nhanson@cfaortho.com
Peter Johnston, MD
- Recruiting
Georgia Bone and Joint
Newnan, Georgia, 30265
Hailey Abercrombie, 770-502-2175, hailey.abercrombie@surgerypartners.com
Michael V Cushing, MD
- Recruiting
North Shore Physicians Group
Peabody, Massachusetts, 01960
Study Investigator, 978-531-0800, rchurchill@mgb.org
Study Coordinator, 978-531-0800, bthorn@mgb.org
- Recruiting
California Pacific Orthopaedics
San Francisco, California, 94118
Andie Stevenson, 415-668-8010 ext. 2031, astevenson@calpacortho.com
Mark A Schrumpf, MD
- Recruiting
Associated Orthopedists of Detroit
Troy, Michigan, 48083
Shariff K. Bishai, DO, 248-952-8080
Shariff K. Bishai, DO
About this study
The goal of this multi-center observational study is to collect long-term clinical outcome information for anatomic and reverse total shoulder arthroplasty (shoulder replacement).
Read the detailed description
The study is a non-randomized, multi-center prospective registry that will collect standard-of-care data for patients who plan to receive or have received shoulder arthroplasty (anatomic or reverse) with a Shoulder Innovations (SI) Total Shoulder System device and consent to participate in the study. The study will evaluate short and long term clinical and radiographic outcomes associated with real-world use of the arthroplasty system from the implant procedure through 10 years post-operatively.
- Conditions
- Shoulder Arthroplasty
- Keywords
- Shoulder Arthroplasty, Shoulder Replacement, Anatomic Shoulder Arthroplasty, Reverse Shoulder Arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Durability of the device component implant
Assessment of the SI device component will be made at specified intervals using x-rays to check how long the device component can stay implanted with or without a revision surgery.
Measured: From the implant procedure until 10 years post-operatively
Secondary outcomes (6)
Change in range of motion (ROM) post-operatively at specified timepoints as compared to baseline
Measured: From baseline (pre-operatively) until 10 years post-operatively
Change in ASES score post-operatively at specified timepoints as compared to baseline
Patients will complete the ASES questionnaire (American Shoulder and Elbow Surgeons Shoulder Score) to evaluate pain and activities of daily living.
Measured: From baseline (pre-operatively) until 10 years post-operatively
Change in SANE score post-operatively at specified timepoints as compared to baseline
Patients will complete the SANE questionnaire (Single Assessment Numeric Evaluation) to rate their affected shoulder as a percentage of normal.
Measured: From baseline (pre-operatively) until 10 years post-operatively
Change in PROMIS Global-10 score post-operatively at specified timepoints as compared to baseline
Patients will complete the PROMIS Global-10 questionnaire (Patient-Reported Outcome Measurement Information System Global-10) to evaluate pain and activities of daily living.
Measured: From baseline (per-operatively) until 10 years post-operatively
Evaluation of radiographic images for radiolucent lines, implant stability and loosening
Measured: From baseline (pre-operatively) until 10 years post-operatively
Rate of intra-operative and post-operative adverse device effects (ADEs)/complications
Measured: From the implant procedure until 10 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start23 Oct 2024
- Primary completionDec 2039 (estimated)
- Study completionDec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 2,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Shoulder Innovations
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754150
- Sponsor's protocol ID
- SICDR 31.0.1.1.1
- Acronym
- SICDR
- Status last verified
- Sep 2026
- First submitted
- 13 Dec 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder Innovations Clinical Data Registry
- ClinicalTrials.gov ID
- NCT06754150
- Acronym / sponsor ID
- SICDR / SICDR 31.0.1.1.1
- Conditions
- Shoulder Arthroplasty
- Keywords
- Shoulder Arthroplasty, Shoulder Replacement, Anatomic Shoulder Arthroplasty, Reverse Shoulder Arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Shoulder InnovationsIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- Dec 2039 (estimated)
- Study completion
- Dec 2039 (estimated)
- First posted
- 31 Dec 2024 (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 goal of this multi-center observational study is to collect long-term clinical outcome information for anatomic and reverse total shoulder arthroplasty (shoulder replacement).
Detailed description
The study is a non-randomized, multi-center prospective registry that will collect standard-of-care data for patients who plan to receive or have received shoulder arthroplasty (anatomic or reverse) with a Shoulder Innovations (SI) Total Shoulder System device and consent to participate in the study. The study will evaluate short and long term clinical and radiographic outcomes associated with real-world use of the arthroplasty system from the implant procedure through 10 years post-operatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (at least 18 years of age) of any gender undergoing a shoulder arthroplasty for any diagnosis/condition with at least one SI Total Shoulder System component enrolled at participating sites
Key inclusion criteria (5 listed)
- At least 18 years of age.
- Plan to receive or has received a shoulder arthroplasty surgical procedure, with a minimum of one implanted Shoulder Innovations (SI) device component and be willing and able to complete post-operative visits as long as at least one SI device component remains implanted.
- Able to provide informed consent prior to enrollment in the study (unless a waiver has been obtained).
- Agree to and be able to consistently answer the specified Patient Reported Outcome Measures (PROM) pre-operatively and at each of the post-operative visits without the use of a translator.
- Willing and able to comply with the requirements of the study protocol
Key exclusion criteria (3 listed)
- Participation in a clinical trial of an investigational drug or device that would confound the results of this trial. Participation in another observational registry is allowed provided there are no conflicting requirements to this trial.
- Incarceration.
- Any conditions, co-morbidities, restrictions, or obligations that would prohibit them from complying with the requirements of this study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Durability of the device component implant
Time frame: From the implant procedure until 10 years post-operatively
Assessment of the SI device component will be made at specified intervals using x-rays to check how long the device component can stay implanted with or without a revision surgery.
6 secondary outcomes
Change in range of motion (ROM) post-operatively at specified timepoints as compared to baseline
Time frame: From baseline (pre-operatively) until 10 years post-operatively
Change in ASES score post-operatively at specified timepoints as compared to baseline
Time frame: From baseline (pre-operatively) until 10 years post-operatively
Change in SANE score post-operatively at specified timepoints as compared to baseline
Time frame: From baseline (pre-operatively) until 10 years post-operatively
Change in PROMIS Global-10 score post-operatively at specified timepoints as compared to baseline
Time frame: From baseline (per-operatively) until 10 years post-operatively
Evaluation of radiographic images for radiolucent lines, implant stability and loosening
Time frame: From baseline (pre-operatively) until 10 years post-operatively
Rate of intra-operative and post-operative adverse device effects (ADEs)/complications
Time frame: From the implant procedure until 10 years post-operatively
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 10 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Arthroplasty, run by Shoulder Innovations at 10 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 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: looking for participants now, as of the sponsor's last update on 10 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 10 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?
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?
Contact Alyson Harris (408-667-0535, alyson.harris@shoulderinnovations.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Durability of the device component implant (time frame: From the implant procedure until 10 years post-operatively). 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 10 Sep 2026.