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Post-Approval Study for Hintermann Series H3 Total Ankle Replacement System

This study is looking at the Hintermann Series H3 Total Ankle Replacement System, an FDA-approved device used to replace painful ankle joints. It's for people with ankle arthritis, including osteoarthritis, arthritis from injuries (post-traumatic osteoarthritis), or arthritis due to inflammatory diseases. The study wants to see how safe and effective this ankle replacement system is over five years. To join, you need to be at least 21 years old, have one of the types of ankle arthritis mentioned, and be willing to participate in follow-up visits. This study helps the FDA ensure the device continues to be safe and effective for patients.

Study design
This is an interventional study planning to enroll 94 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive the Hintermann Series H3 Total Ankle Replacement System and attend follow-up visits for five years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and effectiveness measurements for five years after receiving the ankle replacement.

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NCT04770870

Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System

Active, Not Recruiting
NAAges 21+InterventionalTreatment
DT MedTech, LLC
~94 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:Hintermann Series H3 Total Ankle Replacement System

At a glance

Recruiting sites
0 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Measurement
Measured over 5-years
+1 more outcome measured

Conditions

Osteoarthritis Ankle
Post-Traumatic Osteoarthritis of Ankle
Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)

Explore related trials

ArthritisOsteoarthritisPost traumatic osteoarthritis

Where it's being run

11 sites across 10 states
Florida2
Arkansas1
California1
Indiana1
Maryland1
New Mexico1
North Carolina1
Oklahoma1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
High demanding sport activities (e.g., contact sports, jumping)
Suspected or documented metal allergy or intolerance
Condition or situation which, in the Physician's opinion, puts the subject at significant risk, or may interfere significantly with the subject's participation in the study

What this trial measures

  • Primary Safety Measurement5-years

    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.

  • Primary Effectiveness Measurement5-years

    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.