Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
Post Approval Study 2: Hintermann Series H3 Total Ankle Replacement System
1 other identifier
interventional
232
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2022
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2021
CompletedFirst Posted
Study publicly available on registry
February 25, 2021
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
June 25, 2024
June 1, 2024
7.2 years
February 22, 2021
June 24, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Primary Safety Measurement
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.
5-years
Primary Effectiveness Measurement
The co-primary effectiveness measurements for this study are the American Orthopaedic Foot and Ankle Society (AOFAS) score at 2 years or more, the survivorship (absence of removal/revisions of metal components) within 5 years post-surgery, and the percentage of subjects with a serious device-related adverse event, other than a revision or removal within 2 years.
5-years
Study Arms (1)
Treatment Arm
OTHERAll subjects who meet eligibility, consented, and enrolled into the study will receive treatment.
Interventions
Intervention will include receiving the FDA approved Hintermann Series H3 Total Ankle Replacement System, to include a tibial component, a polyethylene inlay, and a talar component.
Eligibility Criteria
You may qualify if:
- Each potential subject must be an appropriate candidate for mobile bearing TAR by having: a primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease, as determined by the Principle Investigator.
- Willingness to participate in the study and follow-up visits
- Written informed consent, including authorization to release collected health data
You may not qualify if:
- Skeletal immaturity
- Bone stock inadequate to support the device including:
- Severe osteoporotic or osteopenic condition or other conditions resulting in poor bone quality
- Avascular necrosis of the talus
- Active or prior deep infection in the ankle joint or adjacent bones
- Malalignment or severe deformity of involved or adjacent anatomic structures including:
- Hindfoot or forefoot malalignment precluding plantigrade foot
- Significant malalignment of the knee joint
- Insufficient ligament support that cannot be repaired with soft tissue stabilization (syndesmosis disruption)
- Charcot joint or peripheral neuropathy that may lead to Charcot joint of the affected ankle
- Neuromuscular disease resulting in lack of normal muscle function about the affected ankle
- Lower extremity vascular insufficiency demonstrated by Doppler arterial pressure
- Poor skin and soft tissue quality about the surgical site
- Immunosupressive therapy
- Prior ankle fusion or revision of total ankle replacement
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DT MedTech, LLClead
Study Sites (10)
Los Angeles Institute of Foot and Ankle Surgery
Mission Hills, California, 91345, United States
Florida Orthopedic Foot & Ankle Center
Sarasota, Florida, 34233, United States
Paley Orthopedic & Spine Institute
West Palm Beach, Florida, 33407, United States
Orthopaedic Associates
Evansville, Indiana, 47710, United States
Department of Orthopedic Surgery, Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287, United States
New Mexico Bone and Joint Institute
Alamogordo, New Mexico, 88310, United States
Duke Orhtopaedics Arringdon
Morrisville, North Carolina, 27560, United States
Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
MUSC Department of Orthopaedics/Foot and Anke Services
Charleston, South Carolina, 29425, United States
Spring Branch Podiatry, PLLC
Houston, Texas, 77024, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2021
First Posted
February 25, 2021
Study Start
February 1, 2022
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
June 25, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share