Shoulder Innovations Clinical Data Registry
Shoulder Innovations
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).
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 th…
Locations (6)
- St. Vincent's OrthopedicsBirmingham, Alabama
- California Pacific OrthopaedicsSan Francisco, California
- Western OrthopaedicsDenver, Colorado
- Connolly OrthopedicsBradenton, Florida
- Georgia Bone and JointNewnan, Georgia
- North Shore Physicians GroupPeabody, Massachusetts