Actively Recruiting
Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
Led by DT MedTech, LLC · Updated on 2024-06-25
232
Participants Needed
10
Research Sites
373 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be an appropriate candidate for mobile bearing total ankle replacement with a diagnosis of primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease as determined by the Principal Investigator
- Willingness to participate in the study and attend follow-up visits
- Provide written informed consent, including permission to release collected health data
You will not qualify if you...
- Skeletal immaturity
- Bone stock inadequate to support the device, including severe osteoporosis, osteopenia, or avascular necrosis of the talus
- Active or prior deep infection in the ankle joint or adjacent bones
- Severe malalignment or deformity of the foot or knee that prevents a plantigrade foot or proper function
- Insufficient ligament support that cannot be repaired with soft tissue stabilization
- Charcot joint or peripheral neuropathy affecting the ankle
- Neuromuscular disease causing loss of normal muscle function around the ankle
- Lower extremity vascular insufficiency shown by Doppler arterial pressure
- Poor skin and soft tissue quality near the surgical site
- Receiving immunosuppressive therapy
- Prior ankle fusion or revision of total ankle replacement
- Participation in high-demand sports such as contact sports or jumping
- Known or suspected metal allergy or intolerance
- Any condition that in the physician's opinion poses significant risk or interferes with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Los Angeles Institute of Foot and Ankle Surgery
Mission Hills, California, United States, 91345
Actively Recruiting
2
Florida Orthopedic Foot & Ankle Center
Sarasota, Florida, United States, 34233
Actively Recruiting
3
Paley Orthopedic & Spine Institute
West Palm Beach, Florida, United States, 33407
Actively Recruiting
4
Orthopaedic Associates
Evansville, Indiana, United States, 47710
Actively Recruiting
5
Department of Orthopedic Surgery, Johns Hopkins Outpatient Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
6
New Mexico Bone and Joint Institute
Alamogordo, New Mexico, United States, 88310
Actively Recruiting
7
Duke Orhtopaedics Arringdon
Morrisville, North Carolina, United States, 27560
Actively Recruiting
8
Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Terminated
9
MUSC Department of Orthopaedics/Foot and Anke Services
Charleston, South Carolina, United States, 29425
Actively Recruiting
10
Spring Branch Podiatry, PLLC
Houston, Texas, United States, 77024
Actively Recruiting
Research Team
I
In House Clinical Research Associate
CONTACT
S
Study Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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