Registry for shoulder replacement outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• St. Vincent's Orthopedics
  Birmingham, Alabama, United States Recruiting
• 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
• CAO Southern Maryland Orthopaedics
  Leonardtown, Maryland, United States Recruiting

Study contacts

• Study coordinator: Alyson Harris
• Email: alyson.harris@shoulderinnovations.com
• Phone: 408-667-0535

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Does nutrition affect recovery after shoulder replacement with virtual reality–enhanced rehab?

  This project will test whether better nutritional status helps adults 60 and older recover function faster after elective shoulder surgery when they use virtual reality–assisted rehabilitation.

  Recruiting Fondazione Policlinico Universitario Campus Bio-Medico · Rome · NCT07282561

• Lower local anesthetic concentration and rebound shoulder pain after shoulder arthroplasty

  This study tests whether using a lower concentration of local anesthetic in a nerve block reduces rebound pain 24 hours after shoulder replacement surgery.

  Recruiting Phase 4 University of Virginia · Charlottesville, Virginia · NCT07146685

• Oral tranexamic acid after total shoulder replacement to reduce bleeding and help early recovery.

  This Phase 3 study will test whether taking oral tranexamic acid after a total shoulder replacement helps adults 18–79 have less bleeding and better short-term recovery compared with a placebo.

  Recruiting Phase 3 University of Alabama at Birmingham · Birmingham, Alabama · NCT06902714

• Comparing early and delayed rehabilitation after shoulder surgery for fractures

  This study is testing whether starting physical therapy two weeks or six weeks after shoulder surgery helps patients recover better from their fractures.

  Recruiting University of Virginia · Charlottesville, Virginia · NCT06869343

• Post-incision antimicrobial washes to reduce C. acnes after shoulder replacement

  This trial will test whether applying different antimicrobial washes after the first incision lowers C. acnes growth in adults having primary shoulder replacement.

  Recruiting Henry Ford Health System · Detroit, Michigan · NCT06831422

• Registry for shoulder replacement surgeries

  This study is gathering information from people who are having shoulder replacement surgeries to see how well these procedures work and how they affect patients over time.

  Recruiting at 18 sites Arthrex, Inc. · Phoenix, Arizona and 26 other locations · NCT03511586

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.