Registry for shoulder replacement surgeries
Total Shoulder Arthroplasty Multi-Center Registry
Arthrex, Inc. · NCT03511586
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Arthrex, Inc. (industry) |
| Locations | 24 sites (Phoenix, Arizona and 23 other locations) |
| Trial ID | NCT03511586 on ClinicalTrials.gov |
What this trial studies
This study is a multi-center prospective registry aimed at collecting clinical outcomes from patients undergoing anatomic and reverse total shoulder arthroplasty. Participants will be treated according to standard care at their respective centers and will be approached for enrollment after deciding to undergo shoulder arthroplasty. The study aims to enroll at least 500 patients for each type of shoulder arthroplasty, gathering data to evaluate the effectiveness and outcomes of these procedures. The registry will help in understanding the long-term results and patient experiences associated with shoulder replacements.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 100 who are planning to undergo primary or revision shoulder arthroplasty with an Arthrex prosthesis.
Not a fit: Patients with co-morbidities or obligations that would prevent them from participating in the study may not benefit.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights that improve surgical outcomes and patient care for shoulder arthroplasty.
How similar studies have performed: Other similar registries have shown success in improving surgical practices and patient outcomes, indicating a positive precedent for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy. 2. Patient is between the ages of 18 and 100 years. 3. The patient has a planned primary or revision implantation of an anatomic (hemi-arthroplasty or total arthroplasty) or a reverse shoulder prosthesis system manufactured by Arthrex. 4. Patient has a standard of care preoperative CT taken within 6 months that has been submitted for Arthrex VIP (Virtual Implant Positioning) planning. Exclusion Criteria 1\. Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study.
Where this trial is running
Phoenix, Arizona and 23 other locations
- University of Arizona/Banner Health — Phoenix, Arizona, United States (RECRUITING)
- Banner Medical Group — Phoenix, Arizona, United States (RECRUITING)
- Scottsdale, Arizona, United States (RECRUITING)
- Denver, Colorado, United States (RECRUITING)
- University of Connecticut Health Center — Farmington, Connecticut, United States (TERMINATED)
- Andrews Research & Education Foundation — Gulf Breeze, Florida, United States (RECRUITING)
- Advent Health Orlando — Orlando, Florida, United States (RECRUITING)
- NorthShore University Health System — Evanston, Illinois, United States (WITHDRAWN)
- The Trustees of Indiana University — Indianapolis, Indiana, United States (RECRUITING)
- The University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
- Grand Rapids, Michigan, United States (TERMINATED)
- Columbia, Missouri, United States (TERMINATED)
- The Rothman Institute — New York, New York, United States (TERMINATED)
- University of North Carolina — Chapel Hill, North Carolina, United States (RECRUITING)
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (NOT_YET_RECRUITING)
- Cleveland Shoulder Institute — Beachwood, Ohio, United States (ACTIVE_NOT_RECRUITING)
- Medford, Oregon, United States (RECRUITING)
- Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States (ACTIVE_NOT_RECRUITING)
- The Hawkins Foundation — Greenville, South Carolina, United States (RECRUITING)
- Germantown, Tennessee, United States (RECRUITING)
- University of Virginia — Charlottesville, Virginia, United States (RECRUITING)
- Virginia Beach, Virginia, United States (RECRUITING)
- Orthopädische Chirurgie München (OCM) — München, Germany (RECRUITING)
- Schulthess Klinik — Zurich, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Kelly Ganz, BA, CCRC
- Email: kelly.ganz@arthrex.com
- Phone: 1 (800) 933-7001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Shoulder Arthroplasty