Osteoarthritis AnkleNCT04770870
Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
A study testing Hintermann Series H3 Total Ankle Replacement System in people with Osteoarthritis Ankle and Post-Traumatic Osteoarthritis of Ankle, run by DT MedTech, LLC at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis Ankle, Post-Traumatic Osteoarthritis of Ankle, Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)
- What is being tested?
- Hintermann Series H3 Total Ankle Replacement System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Feb 2022to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 18Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Christus St Vincent
Alamogordo, New Mexico, 88310
Department of Orthopedic Surgery, Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287
MUSC Department of Orthopaedics/Foot and Anke Services
Charleston, South Carolina, 29425
Orthopaedic Associates
Evansville, Indiana, 47710
Spring Branch Podiatry, PLLC
Houston, Texas, 77024
Ortho Arkansas
Little Rock, Arkansas, 72204
Los Angeles Institute of Foot and Ankle Surgery
Mission Hills, California, 91345
Duke Orhtopaedics Arringdon
Morrisville, North Carolina, 27560
Dept. of Orthopedic Surgery and Rehabilitation, University of Oklahoma
Oklahoma City, Oklahoma, 73104
Florida Orthopedic Foot & Ankle Center
Sarasota, Florida, 34233
Paley Orthopedic & Spine Institute
West Palm Beach, Florida, 33407
About this study
Official title: Post Approval Study 2: 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 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.
Read the detailed description
The Hintermann Series H3® (H3) prosthesis is a mobile bearing total ankle replacement (TAR) indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis or arthritis secondary to inflammatory disease (e.g., rheumatoid arthritis, hemochromatosis, etc.).
The present version (third generation) of the H3 TAR and the earlier generations of this total ankle system have been marketed (initially in 2003) under a license agreement in Europe, South Korea, Australia, and Canada and other countries outside the U.S. (OUS). The H3 TAR prosthesis has been used in over 20,000 procedures in the markets OUS. The H3 TAR device has not been withdrawn from marketing for any reason.
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
- Osteoarthritis Ankle, Post-Traumatic Osteoarthritis of Ankle, Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)
- Being tested
- Hintermann Series H3 Total Ankle Replacement System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hintermann Series H3 Total Ankle Replacement SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Other | All subjects who meet eligibility, consented, and enrolled into the study will receive treatment. Receives: Device: Hintermann Series H3 Total Ankle Replacement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Feb 2022
- Primary completion1 Sep 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis AnkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multicenter, single arm post approval study of 94 US subjects up to 10 US study sites
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DT MedTech, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770870
- Sponsor's protocol ID
- PAS 002
- Status last verified
- Jun 2026
- First submitted
- 22 Feb 2021
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Approval Study 2: Hintermann Series H3 Total Ankle Replacement System
- ClinicalTrials.gov ID
- NCT04770870
- Acronym / sponsor ID
- PAS 002
- Conditions
- Osteoarthritis Ankle, Post-Traumatic Osteoarthritis of Ankle, Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- DT MedTech, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Hintermann Series H3® (H3) prosthesis is a mobile bearing total ankle replacement (TAR) indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis or arthritis secondary to inflammatory disease (e.g., rheumatoid arthritis, hemochromatosis, etc.).
The present version (third generation) of the H3 TAR and the earlier generations of this total ankle system have been marketed (initially in 2003) under a license agreement in Europe, South Korea, Australia, and Canada and other countries outside the U.S. (OUS). The H3 TAR prosthesis has been used in over 20,000 procedures in the markets OUS. The H3 TAR device has not been withdrawn from marketing for any reason.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicenter, single arm post approval study of 94 US subjects up to 10 US study sites
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Other | Device: Hintermann Series H3 Total Ankle Replacement SystemAll subjects who meet eligibility, consented, and enrolled into the study will receive treatment. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- Skeletal immaturity
- Bone stock inadequate to support the device including:
- Active or prior deep infection in the ankle joint or adjacent bones
- Malalignment or severe deformity of involved or adjacent anatomic structures including:
- Charcot joint or peripheral neuropathy that may lead to Charcot joint of the affected ankle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hintermann Series H3 Total Ankle Replacement SystemIntervention 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. | Device | Treatment Arm |
Primary outcome
Primary Safety Measurement
Time frame: 5-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 Measurement
Time frame: 5-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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hintermann Series H3 Total Ankle Replacement System in people with Osteoarthritis Ankle and Post-Traumatic Osteoarthritis of Ankle, run by DT MedTech, LLC at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Measurement (time frame: 5-years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.