ArthritisNCT02025946
Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis
An observational study of Arthritis, run by Integra LifeSciences Services at 8 sites in 7 countries.
Trial summary
In case of severe ankle arthritis, the two common surgical treatments are tibiotalar arthrodesis and total ankle arthroplasty. Few studies have compared these treatments and it remains difficult to determine which operation is the better solution for end stage ankle arthritis. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Arthritis
- How many people
- 0 participants
- Where
- 8 sitesin 7 countries
- Study dates
- Start not givento Jan 2026
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with isolated symptomatic end-stage ankle arthritis who needs a tibiotalar arthrodesis or a mobile-bearing total ankle arthroplasty, receiving CE-marked medical devices and planned to be operated in compliance with their respective Instructions for Use
Who may be able to join
- Patient with isolated symptomatic end-stage ankle arthritis who needs a tibiotalar arthrodesis or a mobile-bearing total ankle arthroplasty
- Patient receiving CE marked medical devices and planned to be operated in compliance with their respective Instructions for Use
- Patient aged between 40 and 75 years old
Who cannot join
- Patient who already had before his inclusion in this study a tibiotalar arthrodesis or a total ankle arthroplasty in the same ankle
- Patient with planned or existing arthrodesis of adjacent joints (subtalar, talonavicular and calcaneaocuboid joint)
- Patient with ankle deformity > 20° (weight bearing X-rays)
- Patient with history of infection of the ankle joint (positive culture) or current infection of the ankle joint (positive culture)
- Patient with neuropathy or with a history of diabetes mellitus for more than 15 years
- Patient with avascular necrosis of the talus >25%
- Patient already included in the study for the other ankle
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
Belgium2 sites
Katholieke Universiteit Leuven
Leuven
AZ Turnout - Clinic Sint-Jozef
Turnhout
About this study
In case of severe ankle arthritis, the two common surgical treatments are tibiotalar arthrodesis and total ankle arthroplasty. Few studies have compared these treatments and it remains difficult to determine which operation is the better solution for end stage ankle arthritis.
The purpose of the present study is to analyze patient's outcome after each type of ankle surgery and to describe the decision making process.
- Conditions
- Arthritis
- Medical subject headings
- Arthritis
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 |
|---|---|---|
| Total Ankle Arthroplasty | Not described | |
| Tibiotalar Arthrodesis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of reoperations in the total ankle replacement arm and in the tibiotalar arthrodesis arm
Reoperation will be defined as any secondary surgery related to the operated ankle or adjacent joints (subtalar, talonavicular and calcaneocuboid joints), excluding wound healing problems.
Measured: after 5 years of follow-up
Secondary outcomes (4)
Proportion of reoperation in the tibiotalar arthrodesis arm and in the total ankle replacement arm
The proportion of reoperation as defined above and for the whole study period in the tibiotalar arthrodesis arm and in the total ankle replacement arm
Measured: 1, 2, 7 and 10 years
proportion of revision for the whole study period in the tibiotalar arthrodesis arm and in the total ankle replacement arm
For the arthrodesis arm, a revision will be defined as a reoperation for one of the following reasons: nonunion or pseudoarthrosis or malunion. Hardware removal will not be considered as a revision.
For the total ankle arthroplasty arm, a revision will be defined as the change of any metallic component of the implanted device. The incidental change of the polyethylene will not be considered as a revision except when it is broken without any
Measured: 1, 2, 5, 7 and 10 years
The evolution and clinical outcomes
- Pain measured using a Visual Analog Scale (VAS)
- Ankle function measured using the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale
- Level of activity measured using the University of California, Los Angeles (UCLA) activity scale
- Quality of life measured using the EQ5D™ questionnaire
- Arthritis status of adjacent joints measured using the Kellgren-Lawrence grading scale
- Patient satisfaction
Measured: 1, 2, 5, 7 and 10 years
the decision criteria for choosing the surgical technique use
Reason for choosing the Total ANkle Arthroplasty or Tibiotalar Arthrodesis
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeroen De Wachter, Principal investigator, AZ Turnhout
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025946
- Sponsor's protocol ID
- RECON-EMEA-12
- Status last verified
- Aug 2015
- First submitted
- 31 Dec 2013
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis
- ClinicalTrials.gov ID
- NCT02025946
- Acronym / sponsor ID
- RECON-EMEA-12
- Conditions
- Arthritis
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Integra LifeSciences ServicesIndustry (pharma, biotech, devices)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 1 Jan 2014 (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.
In case of severe ankle arthritis, the two common surgical treatments are tibiotalar arthrodesis and total ankle arthroplasty. Few studies have compared these treatments and it remains difficult to determine which operation is the better solution for end stage ankle arthritis.
The purpose of the present study is to analyze patient's outcome after each type of ankle surgery and to describe the decision making process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Ankle Arthroplasty | – | – |
| Tibiotalar Arthrodesis | – | – |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with isolated symptomatic end-stage ankle arthritis who needs a tibiotalar arthrodesis or a mobile-bearing total ankle arthroplasty, receiving CE-marked medical devices and planned to be operated in compliance with their respective Instructions for Use
Key inclusion criteria (3 listed)
- Patient with isolated symptomatic end-stage ankle arthritis who needs a tibiotalar arthrodesis or a mobile-bearing total ankle arthroplasty
- Patient receiving CE marked medical devices and planned to be operated in compliance with their respective Instructions for Use
- Patient aged between 40 and 75 years old
Key exclusion criteria (7 listed)
- Patient who already had before his inclusion in this study a tibiotalar arthrodesis or a total ankle arthroplasty in the same ankle
- Patient with planned or existing arthrodesis of adjacent joints (subtalar, talonavicular and calcaneaocuboid joint)
- Patient with ankle deformity > 20° (weight bearing X-rays)
- Patient with history of infection of the ankle joint (positive culture) or current infection of the ankle joint (positive culture)
- Patient with neuropathy or with a history of diabetes mellitus for more than 15 years
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
proportion of reoperations in the total ankle replacement arm and in the tibiotalar arthrodesis arm
Time frame: after 5 years of follow-up
Reoperation will be defined as any secondary surgery related to the operated ankle or adjacent joints (subtalar, talonavicular and calcaneocuboid joints), excluding wound healing problems.
4 secondary outcomes
Proportion of reoperation in the tibiotalar arthrodesis arm and in the total ankle replacement arm
Time frame: 1, 2, 7 and 10 years
proportion of revision for the whole study period in the tibiotalar arthrodesis arm and in the total ankle replacement arm
Time frame: 1, 2, 5, 7 and 10 years
The evolution and clinical outcomes
Time frame: 1, 2, 5, 7 and 10 years
the decision criteria for choosing the surgical technique use
Time frame: inclusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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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.
Jeroen De Wachter principal investigator
AZ Turnhout
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, run by Integra LifeSciences Services at 8 sites in 7 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 7 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: withdrawn, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, France, Italy, Netherlands, Portugal and 2 more countries. 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 was withdrawn before enrolling participants, so there are no results.
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?
proportion of reoperations in the total ankle replacement arm and in the tibiotalar arthrodesis arm (time frame: after 5 years of follow-up). 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 13 Aug 2015.