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NCT06754150Recruiting

Shoulder Innovations Clinical Data Registry

Shoulder Innovations

Start Date

10/23/2024

Completion Date

12/1/2039

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).

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

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Conditions

Shoulder Arthroplasty

Locations

St. Vincent's Orthopedics

Birmingham, Alabama 35205

United States

St. Vincent's Orthopedics

Birmingham, Alabama 35205

United States

California Pacific Orthopaedics

San Francisco, California 94118

United States

Western Orthopaedics

Denver, Colorado 80222

United States

Connolly Orthopedics

Bradenton, Florida 34208

United States

Georgia Bone and Joint

Newnan, Georgia 30265

United States

North Shore Physicians Group

Peabody, Massachusetts 01960

United States

University Medical Center of Southern Nevada

Las Vegas, Nevada 89102

United States