RecruitingNCT06754150

Shoulder Innovations Clinical Data Registry

Sponsor

Shoulder Innovations

Enrollment

2,500 participants

Start Date

Oct 23, 2024

Study Type

OBSERVATIONAL

Conditions

SHOULDER ARTHROPLASTY

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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

Exclusion Criteria3

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.

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