Registry for shoulder replacement outcomes

Shoulder Innovations Clinical Data Registry

This study is collecting information from patients who have shoulder replacement surgery to see how well the new shoulder system works over time.

Quick facts

• Study type: Observational
• Enrollment: 2500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shoulder Innovations (Industry-sponsored)
• Locations: 8 sites (Birmingham, Alabama and 7 other locations)
• Trial ID: NCT06754150 on ClinicalTrials.gov

What this trial studies

This multi-center observational study aims to gather long-term clinical outcome data for patients undergoing anatomic or reverse total shoulder arthroplasty using the Shoulder Innovations Total Shoulder System. It is a non-randomized, prospective registry that collects standard-of-care data from patients who consent to participate. The study will evaluate both short and long-term clinical and radiographic outcomes associated with the use of this arthroplasty system, tracking patients from the implant procedure through 10 years post-operatively.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are planning to receive or have already undergone shoulder arthroplasty with at least one Shoulder Innovations device component.

Not a fit: Patients currently participating in a clinical trial of an investigational drug or device that may interfere with this study's results may not benefit.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of shoulder arthroplasty, improving patient outcomes.

How similar studies have performed: Other observational registries have successfully provided valuable data on similar surgical procedures, indicating a potential for success in this approach.

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.

Where this trial is running

Birmingham, Alabama and 7 other locations

• St. Vincent's Orthopedics — Birmingham, Alabama, United States (Recruiting)
• St. Vincent's Orthopedics — Birmingham, Alabama, United States (Enrolling_by_invitation)
• California Pacific Orthopaedics — San Francisco, California, United States (Recruiting)
• Western Orthopaedics — Denver, Colorado, United States (Recruiting)
• Connolly Orthopedics — Bradenton, Florida, United States (Recruiting)
• Georgia Bone and Joint — Newnan, Georgia, United States (Recruiting)
• North Shore Physicians Group — Peabody, Massachusetts, United States (Recruiting)
• University Medical Center of Southern Nevada — Las Vegas, Nevada, United States (Enrolling_by_invitation)

Study contacts

• Study coordinator: Alyson Harris

Conditions Shoulder Arthroplasty; Shoulder Replacement; Anatomic Shoulder Arthroplasty; Reverse Shoulder Arthroplasty