Shoulder Innovations Clinical Data Registry (SICDR)

May 8, 2026 updated by: Shoulder Innovations
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • St. Vincent's Orthopedics
        • Contact:
        • Principal Investigator:
          • David Adkison, MD
      • Birmingham, Alabama, United States, 35205
        • Enrolling by invitation
        • St. Vincent's Orthopedics
    • California
      • San Francisco, California, United States, 94118
        • Recruiting
        • California Pacific Orthopaedics
        • Contact:
        • Principal Investigator:
          • Mark A Schrumpf, MD
    • Colorado
    • Florida
      • Bradenton, Florida, United States, 34208
        • Recruiting
        • Connolly Orthopedics
        • Contact:
        • Principal Investigator:
          • Brendon Connolly, MD
    • Georgia
      • Newnan, Georgia, United States, 30265
    • Massachusetts
      • Peabody, Massachusetts, United States, 01960
        • Recruiting
        • North Shore Physicians Group
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ryan W Churchill, MD
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Enrolling by invitation
        • University Medical Center of Southern Nevada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  1. At least 18 years of age.
  2. 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.
  3. Able to provide informed consent prior to enrollment in the study (unless a waiver has been obtained).
  4. 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.
  5. Willing and able to comply with the requirements of the study protocol

Exclusion Criteria:

  1. 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.
  2. Incarceration.
  3. Any conditions, co-morbidities, restrictions, or obligations that would prohibit them from complying with the requirements of this study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From the implant procedure until 10 years post-operatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Patients will complete the ASES questionnaire (American Shoulder and Elbow Surgeons Shoulder Score) to evaluate pain and activities of daily living.
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
Patients will complete the SANE questionnaire (Single Assessment Numeric Evaluation) to rate their affected shoulder as a percentage of normal.
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
Patients will complete the PROMIS Global-10 questionnaire (Patient-Reported Outcome Measurement Information System Global-10) to evaluate pain and activities of daily living.
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
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
From the implant procedure until 10 years post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shoulder Innovations

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2039

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2039

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SICDR 31.0.1.1.1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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