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Shoulder Innovations Clinical Data Registry

RecruitingN/A

Sponsor: Shoulder Innovations

Conditions: Shoulder Arthroplasty

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (10)

Birmingham, Alabama, United States
Birmingham, Alabama, United States
San Francisco, California, United States
Denver, Colorado, United States
Bradenton, Florida, United States
Newnan, Georgia, United States
Leonardtown, Maryland, United States
Peabody, Massachusetts, United States
Troy, Michigan, United States
Las Vegas, Nevada, United States