Ankle OsteoarthritisNCT06514196
Post- Approval Hintermann Series H® Study 1
An observational study of Ankle Osteoarthritis and Post-Traumatic Osteoarthritis of Ankle, run by DT MedTech, LLC at 1 site in Switzerland.
Trial summary
The H3 TAR device received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) on June 4, 2019, and as a condition of that approval, this study is being conducted to provide long-term safety and effectiveness of the H3 TAR System among patients included in the Primary Safety and Effectiveness (PSE) Cohort… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Ankle Osteoarthritis, 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
- How many people
- 298 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Jun 2020to 20 Jan 2025
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The study population will consist of all living subjects who participated in the PSE cohort, regardless of whether or not the subject has had a removal/revision followed through the 10-year post-operation visit.
Who may be able to join
- Skeletally mature
- Primary diagnosis of osteoarthritis, post-traumatic arthritis or rheumatoid arthritis
- Primary total ankle replacement
- Unilateral or the first ankle implanted if bilateral and the surgery dates for both sides are at least 6 months apart
- Implanted with the correct device without screws (for investigational arm),
- 3rd generation Hintermann Series H3 Total Ankle Replacement;
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- Poor pre-operative American Orthopaedic Foot and Ankle Society Hindfoot Score (< 60 points)
- Implanted in 2013 or earlier). Note that all subjects implanted in 2013 or earlier were included regardless of whether they were revised prior to the 2 year endpoint.
- Gave informed consent (unless IRB/Ethics Committee waived this requirement)
Who cannot join
- Prior TAR or arthrodesis at the involved ankle joint
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post- Approval Study 1: Long Term Follow Up of the Hintermann Series H® Total Ankle Replacement System
The H3 TAR device received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) on June 4, 2019, and as a condition of that approval, this study is being conducted to provide long-term safety and effectiveness of the H3 TAR System among patients included in the Primary Safety and Effectiveness (PSE) Cohort (P1600361).
This will be a Prospective, single-center, single arm study.
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.).
This will be a Prospective, single-center, single arm study. All living subjects who participated in the PSE cohort, regardless of whether or not the subject has had a revision/removal followed through the 10-year post-operation visit. 298 subjects were originally included in the PSE cohort.
Through 10 years follow up. Based on the last surgery date, it is projected the study will be completed with the final 10-year follow-up visit to occur in December 2024.
Patients will undergo clinical and radiographic evaluation at 5 and 10 years (+/- 90 days) post-operation.
Performance Goals (PGs) will be constructed for the 10-year endpoint. As with the PGs used in the PMA study, these will be based on a prospectively defined, systematic meta-analysis of available published literature and registry data for the control (a legally marketed mobile bearing ankle). The details of the meta-analysis will be pre-specified in a protocol for this purpose. Both the protocol and the meta-analysis will be completed prior to the completion of the study.
- Conditions
- Ankle Osteoarthritis, 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
The H3 includes a metal tibial component, a polyethylene sliding insert (PE inlay), and a metal talar component.
What is being measured
The primary outcome is the main question the study is designed to answer.
AOFAS Score Measurement
The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score is among will be used for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It will be measured at a minimum 10 years post-operation
Measured: 10 Years
Survivorship Measurement
Survivorship (absence of removal/revisions to include polyethylene revision) will be recorded at 10 years from surgery
Measured: 10 Years
Serious device-related adverse event Measurement
Percentage of subjects with a serious device-related adverse event, other than a revision or removal will be calculated at 10 years from surgery
Measured: 10 Years
Reoperation, revisions or removals Measurement
Safety Reporting of the reoperation, revisions or removals of the Hintermann Ankle device will be reviewed and analyzed
Measured: 10 Years
Serious Device-Related Adverse Events Measurement
Incidence, occurrence, and types of serious device-related adverse events will be reviewed and analyzed for subjects Nature, onset, duration, severity, relationship to the device, and relationship to the operative procedure and outcome of any adverse event will be measured.
Measured: 10 Years
Device Explant Analysis Measurement
Any explanted devices / device components will be returned and handled for analysis as described in Attachment G: Explant and Revision Protocol, to be examined for wear and damage.
Measured: Through Study Completion an Average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start18 Jun 2020
- Primary completion30 Nov 2024 (estimated)
- Study completion20 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle OsteoarthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 298 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- DT MedTech, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beat Hintermann, Principal investigator, Cantonal Hospital, Baselland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514196
- Sponsor's protocol ID
- PAS 001
- Status last verified
- Jul 2024
- First submitted
- 20 Jun 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post- Approval Study 1: Long Term Follow Up of the Hintermann Series H® Total Ankle Replacement System
- ClinicalTrials.gov ID
- NCT06514196
- Acronym / sponsor ID
- PAS 001
- Conditions
- Ankle Osteoarthritis, Post-Traumatic Osteoarthritis of Ankle, Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 298 participants (estimated)
- Lead sponsor
- DT MedTech, LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 23 Jul 2024 (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 device received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) on June 4, 2019, and as a condition of that approval, this study is being conducted to provide long-term safety and effectiveness of the H3 TAR System among patients included in the Primary Safety and Effectiveness (PSE) Cohort (P1600361).
This will be a Prospective, single-center, single arm study.
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.).
This will be a Prospective, single-center, single arm study. All living subjects who participated in the PSE cohort, regardless of whether or not the subject has had a revision/removal followed through the 10-year post-operation visit. 298 subjects were originally included in the PSE cohort.
Through 10 years follow up. Based on the last surgery date, it is projected the study will be completed with the final 10-year follow-up visit to occur in December 2024.
Patients will undergo clinical and radiographic evaluation at 5 and 10 years (+/- 90 days) post-operation.
Performance Goals (PGs) will be constructed for the 10-year endpoint. As with the PGs used in the PMA study, these will be based on a prospectively defined, systematic meta-analysis of available published literature and registry data for the control (a legally marketed mobile bearing ankle). The details of the meta-analysis will be pre-specified in a protocol for this purpose. Both the protocol and the meta-analysis will be completed prior to the completion of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of all living subjects who participated in the PSE cohort, regardless of whether or not the subject has had a removal/revision followed through the 10-year post-operation visit.
Key inclusion criteria (9 listed)
- Skeletally mature
- Primary diagnosis of osteoarthritis, post-traumatic arthritis or rheumatoid arthritis
- Primary total ankle replacement
- Unilateral or the first ankle implanted if bilateral and the surgery dates for both sides are at least 6 months apart
- Implanted with the correct device without screws (for investigational arm),
Key exclusion criteria (1 listed)
- Prior TAR or arthrodesis at the involved ankle joint
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 SystemThe H3 includes a metal tibial component, a polyethylene sliding insert (PE inlay), and a metal talar component. | Device | – |
Primary outcome
AOFAS Score Measurement
Time frame: 10 Years
The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score is among will be used for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It will be measured at a minimum 10 years post-operation
Survivorship Measurement
Time frame: 10 Years
Survivorship (absence of removal/revisions to include polyethylene revision) will be recorded at 10 years from surgery
Serious device-related adverse event Measurement
Time frame: 10 Years
Percentage of subjects with a serious device-related adverse event, other than a revision or removal will be calculated at 10 years from surgery
Reoperation, revisions or removals Measurement
Time frame: 10 Years
Safety Reporting of the reoperation, revisions or removals of the Hintermann Ankle device will be reviewed and analyzed
Serious Device-Related Adverse Events Measurement
Time frame: 10 Years
Incidence, occurrence, and types of serious device-related adverse events will be reviewed and analyzed for subjects Nature, onset, duration, severity, relationship to the device, and relationship to the operative procedure and outcome of any adverse event will be measured.
Device Explant Analysis Measurement
Time frame: Through Study Completion an Average of 10 years
Any explanted devices / device components will be returned and handled for analysis as described in Attachment G: Explant and Revision Protocol, to be examined for wear and damage.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
Beat Hintermann principal investigator
Cantonal Hospital, Baselland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Osteoarthritis and Post-Traumatic Osteoarthritis of Ankle, run by DT MedTech, LLC at 1 site in Switzerland.
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 9 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Results are not available in the source record.
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?
AOFAS Score Measurement (time frame: 10 Years). The study lists 6 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 23 Jul 2024.