๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-05-06

AETOS Shoulder System (NCT06319911)

AETOS Shoulder System Post Market Clinical Investigation

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Smith & Nephew, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. No intra-study comparator group will be included, and there will be no randomization

Who can join: Review the eligibility criteria below.

Location: California Pacific Orthopedics โ€” San Francisco, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (5 Sites)

  • California Pacific Orthopedics โ€” San Francisco, California
  • Western Orthopaedics โ€” Denver, Colorado
  • Hughston Foundation โ€” Columbus, Georgia
  • Center for Orthopedics and Neurosurgical Care โ€” Bend, Oregon
  • Rothman Institute โ€” Philadelphia, Pennsylvania

๐Ÿ“ž Contact the Study Coordinator

Phone: (351) 226-9585

Email: tammy.clark@smith-nephew.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—