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Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
NCT04770870 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Hintermann Series H3 Total Ankle Replacement System
Study Locations (10)
Florida
- Florida Orthopedic Foot & Ankle Center — Sarasota
- Paley Orthopedic & Spine Institute — West Palm Beach
California
- Los Angeles Institute of Foot and Ankle Surgery — Mission Hills
Indiana
- Orthopaedic Associates — Evansville
Maryland
- Department of Orthopedic Surgery, Johns Hopkins Outpatient Center — Baltimore
New Mexico
- New Mexico Bone and Joint Institute — Alamogordo
North Carolina
- Duke Orhtopaedics Arringdon — Morrisville
Oklahoma
- Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma — Oklahoma City
South Carolina
- MUSC Department of Orthopaedics/Foot and Anke Services — Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2022-02-01 |
| Est. Completion | 2029-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04770870
The ClinicalTrials.gov registry entry for NCT04770870 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 232 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DT MedTech, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Osteoarthritis Ankle appearing as the primary indexed condition, and to 1 intervention — of which Hintermann Series H3 Total Ankle Replacement System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04770870 reports 10 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04770870 about?
NCT04770870 is a clinical study titled "Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System". 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 an...
What is the current status of trial NCT04770870?
This trial is currently recruiting. It is a NA study. The enrollment target is 232 participants. The study started on 2022-02-01. Estimated completion is 2029-04.
What conditions does trial NCT04770870 study?
This clinical trial studies the following conditions: Osteoarthritis Ankle, Post-Traumatic Osteoarthritis of Ankle, Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04770870?
The interventions under investigation include: Hintermann Series H3 Total Ankle Replacement System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04770870?
This trial is sponsored by DT MedTech, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04770870 being conducted?
This trial has 10 study locations across California, Florida, Indiana, Maryland, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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