๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-19

Affixus Natural Nail System Humeral Nail PMCF (NCT05019664)

Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Affixus Natural Nail System Humeral Nail (Implants and Instrumentation)

๐Ÿ”ต Active, Not Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Zimmer Biomet

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

A commercially available product clinical study which aims to confirm the safety, performance and clinical benefits to the patient of the Affixus Natural Nail upper arm (humerus) bone nail system for both the implant itself and the instrumentation used during surgery.

Who can join: Review the eligibility criteria below.

Location: University of Texas Health Science Center at San Antonio โ€” San Antonio, Texas

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)

  • University of Texas Health Science Center at San Antonio โ€” San Antonio, Texas
  • UZ Leuven - Traumatology Department โ€” Leuven,
  • General Foundation of the University of Valladolid โ€” Valladolid, Valladolid
  • Hospital de la Santa Creu i Sant Pau โ€” Barcelona,
  • Kantonsspital Frauenfeld โ€” Frauenfeld, Thurgau

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. Review the official NIH record below to find the coordinating site.
  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†—