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

Recruiting

Conditions

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

Observational

Enrollment (Estimated)

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 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

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

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

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

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)

October 23, 2024

Primary Completion (Estimated)

December 1, 2039

Study Completion (Estimated)

December 1, 2039

Study Registration Dates

First Submitted

December 13, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

December 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID 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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