Shoulder Innovations Clinical Data Registry

Description

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).

Conditions

Shoulder Arthroplasty

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Study Overview

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Study Details

Study overview

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).

Shoulder Innovations Clinical Data Registry

Shoulder Innovations Clinical Data Registry

Condition
Shoulder Arthroplasty
Intervention / Treatment

-

Contacts and Locations

Denver

Western Orthopaedics, Denver, Colorado, United States, 80218

Duxbury

Plymouth Bay Orthopaedic Associates, Duxbury, Massachusetts, United States, 02332

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Shoulder Innovations,

Study Record Dates

2039-12