Total Ankle ProsthesisNCT01284972
HINTEGRA Total Ankle Prosthesis Follow-up
An observational study of Total Ankle Prosthesis, run by Integra LifeSciences Services at 6 sites in 6 countries.
Trial summary
The Hintegra® Total Ankle Prosthesis is a non constrained, three-component prosthesis that consists of a flat tibial component, an anatomically-shaped talar component, and a high-density polyethylene inlay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Ankle Prosthesis
- How many people
- 225 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Feb 2009to Dec 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient implanted with an Hintegra® Total Ankle Prosthesis (only prosthesis designed with pegs) in primary ankle surgery since a minimum of 2 years
Who may be able to join
- Patient implanted with an Hintegra® Total Ankle Prosthesis (only prosthesis designed with pegs) in primary ankle surgery since a minimum of 2 years
- Age ≥ 18 years
- Have willingness to give his/her data transfer authorisation
Who cannot join
- History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: Short to Mid Term Follow-up of Patient Implanted With the HINTEGRA® Total Ankle Prosthesis
The Hintegra® Total Ankle Prosthesis is a non constrained, three-component prosthesis that consists of a flat tibial component, an anatomically-shaped talar component, and a high-density polyethylene inlay. The Hintegra ankle was specifically developed as an attempt to address the needs of minimal bone resection, extended bone support, proper ligament balancing, and minimal contact stressed within and around the prosthesis.
The objective of this study is to evaluate the safety and efficacy of the HINTEGRA® Total Ankle prosthesis at short and mid term follow up.
- Conditions
- Total Ankle Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HINTEGRA | Patient Implanted with the HINTEGRA Total Ankle Prosthesis more than 2 years ago |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of device related complications at the follow up after 2 years of implantation
Measured: more than 2 years after the implantation
Secondary outcomes (1)
AOFAS Ankle-Hindfoot Scale score (American Orthopaedic Foot and Ankle Society).
Measured: more than 2 years after the implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startFeb 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Ankle ProsthesisStudies 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
- Case only
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284972
- Sponsor's protocol ID
- RECON-EMEA-02
- Status last verified
- Oct 2012
- First submitted
- 26 Jan 2011
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short to Mid Term Follow-up of Patient Implanted With the HINTEGRA® Total Ankle Prosthesis
- ClinicalTrials.gov ID
- NCT01284972
- Acronym / sponsor ID
- RECON-EMEA-02
- Conditions
- Total Ankle Prosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Integra LifeSciences ServicesIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Jan 2011 (estimated)
- 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 Hintegra® Total Ankle Prosthesis is a non constrained, three-component prosthesis that consists of a flat tibial component, an anatomically-shaped talar component, and a high-density polyethylene inlay. The Hintegra ankle was specifically developed as an attempt to address the needs of minimal bone resection, extended bone support, proper ligament balancing, and minimal contact stressed within and around the prosthesis.
The objective of this study is to evaluate the safety and efficacy of the HINTEGRA® Total Ankle prosthesis at short and mid term follow up.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HINTEGRA | – | –Patient Implanted with the HINTEGRA Total Ankle Prosthesis more than 2 years ago |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient implanted with an Hintegra® Total Ankle Prosthesis (only prosthesis designed with pegs) in primary ankle surgery since a minimum of 2 years
Key inclusion criteria (3 listed)
- Patient implanted with an Hintegra® Total Ankle Prosthesis (only prosthesis designed with pegs) in primary ankle surgery since a minimum of 2 years
- Age ≥ 18 years
- Have willingness to give his/her data transfer authorisation
Key exclusion criteria (1 listed)
- History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
rate of device related complications at the follow up after 2 years of implantation
Time frame: more than 2 years after the implantation
1 secondary outcome
AOFAS Ankle-Hindfoot Scale score (American Orthopaedic Foot and Ankle Society).
Time frame: more than 2 years after the implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
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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.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Ankle Prosthesis, run by Integra LifeSciences Services at 6 sites in 6 countries.
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 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: finished, as of the sponsor's last update on 10 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Austria, Canada, France, Germany, South Korea and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
rate of device related complications at the follow up after 2 years of implantation (time frame: more than 2 years after the implantation). 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 10 Oct 2012.