🏛️ Verified NIH Record • Updated 2026-02-09

Evaluate the Continued Safety and Performance of the Foot and Ankle Products (NCT04715139)

A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of the Foot and Ankle Products

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Arthrex, Inc.

🩺 Plain-English Summary (8th-Grade Level)

The objective of the registry is to evaluate the continued safety and performance of Arthrex foot and ankle products, including the ProStop® implant for hyperpronated foot; Bio-Compression Screw for reconstruction surgeries of the foot; TRIM-IT Drill Pin® system and/or TRIM-IT Spin Pin™ system for fixation of fractures and fusion (bunionectomy osteotomies) of the foot/ankle; Headless Compression Screws and Compression FT Screws for fixation of small bone fragments of the foot/ankle; DynaNite® nitinol staple for midfoot and hindfoot arthrodeses or osteotomies, first metatarsophalangeal arthrodesis, and mono or bi-cortical osteotomies in the forefoot; BioComposite SutureTak® anchor for medial ankle stabilization; Beveled FT Screws for hallux valgus repair; KreuLock™ screws for ankle fractures; ArthroFLEX® dermal allograft for hallux rigidus arthroplasty; and DualCompression Hindfoot Nail for tibiotalocalcaneal arthrodesis.

Who can join: Review the eligibility criteria below.

Location: UC Davis Medical Center — Sacramento, California

Age range: 2 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (7 Sites)

  • UC Davis Medical Center — Sacramento, California
  • Northwestern University — Chicago, Illinois
  • TOA Research Foundation — Nashville, Tennessee
  • Barrett Podiatry — San Antonio, Texas
  • Atlantic Orthopaedic Specialists — Virginia Beach, Virginia
  • OrthoPedes — Duisburg,
  • Dr Haroun Mahomed Orthopaedic Practice — Durban,

📞 Contact the Study Coordinator

Phone: (770) 584-4972

Email: justin.moss@arthrex.com

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

💰 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 § 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.

💡 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.
🏛️ View Official NIH Record ↗