Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
Public ClinicalTrials.gov record NCT04770870. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Post Approval Study 2: Hintermann Series H3 Total Ankle Replacement System
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04770870
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 94 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 1, 2022 (Actual)
- Primary completion
- Sep 1, 2029 (Estimated)
- Completion
- Dec 31, 2029 (Estimated)
- Last update posted
- Jun 22, 2026
2022 – 2029
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ortho Arkansas | Little Rock | Arkansas | 72204 | — |
| Los Angeles Institute of Foot and Ankle Surgery | Mission Hills | California | 91345 | — |
| Florida Orthopedic Foot & Ankle Center | Sarasota | Florida | 34233 | — |
| Paley Orthopedic & Spine Institute | West Palm Beach | Florida | 33407 | — |
| Orthopaedic Associates | Evansville | Indiana | 47710 | — |
| Department of Orthopedic Surgery, Johns Hopkins Outpatient Center | Baltimore | Maryland | 21287 | — |
| Christus St Vincent | Alamogordo | New Mexico | 88310 | — |
| Duke Orhtopaedics Arringdon | Morrisville | North Carolina | 27560 | — |
| Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma | Oklahoma City | Oklahoma | 73104 | — |
| MUSC Department of Orthopaedics/Foot and Anke Services | Charleston | South Carolina | 29425 | — |
| Spring Branch Podiatry, PLLC | Houston | Texas | 77024 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04770870, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 22, 2026 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04770870 live on ClinicalTrials.gov.