Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System (NCT04770870)
Post Approval Study 2: Hintermann Series H3 Total Ankle Replacement System
🩺 Plain-English Summary (8th-Grade Level)
The H3 TAR Prosthesis was approved by FDA (P160036) on June 4, 2019. Continued approval of the premarket approval application (PMA) is contingent upon the submission of periodic reports (Annual Report), required under 21 CFR 814.84. In order to provide continued reasonable assurance of the safety and effectiveness of the PMA device, data from this post-approval study must be submitted to FDA in a PMA Post-Approval Study Report per the requirements set forth in the approval.
Who can join: Review the eligibility criteria below.
Location: Ortho Arkansas — Little Rock, Arkansas
Age range: 21 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (11 Sites)
- Ortho Arkansas — Little Rock, Arkansas
- Los Angeles Institute of Foot and Ankle Surgery — Mission Hills, California
- Florida Orthopedic Foot & Ankle Center — Sarasota, Florida
- Paley Orthopedic & Spine Institute — West Palm Beach, Florida
- Orthopaedic Associates — Evansville, Indiana
- Department of Orthopedic Surgery, Johns Hopkins Outpatient Center — Baltimore, Maryland
- Christus St Vincent — Alamogordo, New Mexico
- Duke Orhtopaedics Arringdon — Morrisville, North Carolina
- Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma — Oklahoma City, Oklahoma
- MUSC Department of Orthopaedics/Foot and Anke Services — Charleston, South Carolina
- Spring Branch Podiatry, PLLC — Houston, Texas
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.