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NCT04770870 · ClinicalTrials.gov registry record · NA
Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
A NA study of Osteoarthritis Ankle and Post-Traumatic Osteoarthritis of Ankle, sponsored by DT MedTech.
- Recruiting
- Registry status
- NA
- Development phase
- 232
- Enrollment target
- 10
- Study locations
NCT04770870 is a NA study of Osteoarthritis Ankle and Post-Traumatic Osteoarthritis of Ankle that is actively recruiting participants, run by DT MedTech. The registered enrollment target is 232 participants, below the 6,673-participant average among 3 other Osteoarthritis Ankle trials with a reported enrollment target (97% lower). The trial reports 10 study locations across 9 states.
The verdict
NCT04770870, a NA study of Osteoarthritis Ankle and Post-Traumatic Osteoarthritis of Ankle, is actively recruiting participants, sponsored by DT MedTech.
- RECRUITING
- Registry status
- NA
- Development phase
- 232 participants
- Enrollment target
- 10
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 232 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,673-participant average among 3 other Osteoarthritis Ankle trials with a reported enrollment target (97% lower). The listed sponsor is DT MedTech, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT04770870 reports 10 study locations spanning 9 distinct geographic areas - top geographies include Florida, California, Indiana.
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).
What interventions are being tested in trial NCT04770870?
The interventions under investigation include: Hintermann Series H3 Total Ankle Replacement System (DEVICE).
Who is sponsoring clinical trial NCT04770870?
This trial is sponsored by DT MedTech, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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