Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting NA study of Osteoarthritis Ankle and Post-Traumatic Osteoarthritis of Ankle, sponsored by DT MedTech.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Primary Safety Measurement for this study is the percentage of patient subjects with a serious device-related adverse event, other than a revision or removal within 2 years.
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 |
What NCT04770870 shows while recruiting
NCT04770870 is an interventional study that assigns participants to a tested intervention. The registered 232 participants enrollment target is mid-sized for trials with a published cap, below the 6,673-participant average among 3 other Osteoarthritis Ankle trials with a reported enrollment target (97% lower).
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 lists 10 locations in 9 states (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.
Learn More About Clinical Trials
Similar trials for Osteoarthritis Ankle
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01356290 · 232 participants · Phase 2
Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors
- NCT04753359 · 232 participants · NA
Mediterranean Diet and Weight Loss: Targeting the Bile Acid/Gut Microbiome Axis to Reduce Colorectal Cancer
- NCT05948943 · 232 participants · Phase 2
Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
- NCT06213649 · 232 participants · Phase 3
Parasitic Ulcer Treatment Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI