Shoulder Innovations Clinical Data Registry

NCT ID: NCT06754150

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-23

Study Completion Date

2039-12-31

Brief Summary

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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

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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

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Shoulder Arthroplasty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shoulder Innovations

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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California Pacific Orthopaedics

San Francisco, California, United States

Site Status RECRUITING

Western Orthopaedics

Denver, Colorado, United States

Site Status RECRUITING

Connolly Orthopedics

Bradenton, Florida, United States

Site Status RECRUITING

Georgia Bone and Joint

Newnan, Georgia, United States

Site Status RECRUITING

North Shore Physicians Group

Peabody, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alyson Harris

Role: CONTACT

408-667-0535

Michele La Badie

Role: CONTACT

615-603-8110

Facility Contacts

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Andie Stevenson

Role: primary

415-668-8010 ext. 2031

Mallory Boyd

Role: primary

303-253-7353

Libby Mauter

Role: backup

303-253-7378

Alexis Connolly, MSN, APRN, FNP-BC

Role: primary

(941) 757-3521

Hailey Abercrombie

Role: primary

770-502-2175

Study Investigator

Role: primary

978-531-0800

Study Coordinator

Role: backup

978-531-0800

Other Identifiers

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SICDR 31.0.1.1.1

Identifier Type: -

Identifier Source: org_study_id

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