Ankle ArthritisNCT03650010
Total Ankle Replacement: Clinical and Radiological Outcomes
An observational study of Ankle Arthritis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
This retrospective and prospective study intends to evaluate the epidemiology and effectiveness of ankle joint surgery in patients operated from January 2011 to March 2026, evaluating the results both clinically and radiographically. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankle Arthritis
- What is being tested?
- Total ankle replacement
- Type of treatment
- Surgery or procedure
- How many people
- 1,066 participants
- Where
- 1 siteItaly
- Study dates
- 11 May 2016to 31 Mar 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1066 patients who underwent total ankle replacement
Who may be able to join
- Males and females
- age ≥ 18 years at the time of surgery
- patients who underwent ankle replacement surgery from January 2011 to March 2026
Who cannot join
- age < 18 years at the time of surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Irccs Istituto Ortopedico Galeazzi
Milan, Milano, 20156
Federico Usuelli, MD, +39335 7351838, fusuelli@gmail.com
Federico Usuelli, MD
About this study
Official title: Evaluation of Epidemiology and Radiological and Clinical Outcomes in Total Ankle Prosthesis
This retrospective and prospective study intends to evaluate the epidemiology and effectiveness of ankle joint surgery in patients operated from January 2011 to March 2026, evaluating the results both clinically and radiographically.
Read the detailed description
The aim of this study is to evaluate radiographically and clinically using clinical and radiographic outcomes . Few studies exist in the literature and rarely report fix-bearing and mobile-bearing prosthetics [1-4]. Therefore the data related to this study can be considered a reference in the literature.
Patients who performed and will perform ankle prosthesis surgery from January 2011 to March 2026 and who underwent a clinical evaluation (also using questionnaires and scores) and radiographic evaluation.
The clinical data and radiological parameters were collected together with the visits and the procedures prescribed according to the clinical routine of the department.
- Conditions
- Ankle Arthritis
- Being tested
- Total ankle replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total ankle replacementProcedure or surgery
total ankle prosthesis through a lateral or an anterior approach
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in American orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score
The American orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient (to assess sagittal motion, hindfoot motion, ankle-hindfoot stability and alignment of the ankle-hindfoot). The scale includes nine items that can be divided into three subscales (pain, function and alignment). Pain consists of one item with a maximal score of 40 points, indicating no pain. Function consists of seven items with a maximal score of 50 points, indicating full function. Alignment consists of one item with a maximal score of 10 points, indicating good alignment. The maximal score is 100 points, indicating no symptoms or impairments.
Measured: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively
Changes in Short form 12 (SF 12)
The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey (Ware, Kosinski, and Keller, 1996). The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Measured: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively
Anterior distal tibial angle
(ADTA: normal value 83.0 ± 3.6 degrees). The angle is subtended by the anatomic axis of the tibia and the line connecting the distal points on the anterior and posterior tibial articular surface on the anterior side (Figure 1). The tibia axis was defined as the line connecting the centres of two circles designed over the proximal and the distal tibia adjusting their radius to the anterior and posterior tibial cortices.
Measured: Pre operatively
Changes in beta angle
β-angle (normal value 85.0 ± 2.0 degrees). This angle is subtended anteriorly by the longitudinal axis of the tibia and the articular surface of the tibial component on the lateral view
Measured: 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively
Changes in alpha angle
the α-angle is formed by the angle between the anatomic axis of the tibia and the articular surface of the tibial component on the AP view (normal value 90.0 ± 2.0 degrees)
Measured: 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively
Medial distal tibial angle
It is the angle between the anatomic axis of the tibia and the line connecting the distal point on the medial and lateral articular surface. (normal value 92.4 ± 3.1 degrees).
Measured: Pre operatively
Secondary outcomes (1)
Changes in visual analogue scale
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
Measured: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start11 May 2016
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle ArthritisStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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-control
- Time perspective
- Other
- Enrolment
- 1,066 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Cittera, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650010
- Sponsor's protocol ID
- Tarus
- Status last verified
- Aug 2018
- First submitted
- 8 Dec 2017
- Last updated
- 28 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Epidemiology and Radiological and Clinical Outcomes in Total Ankle Prosthesis
- ClinicalTrials.gov ID
- NCT03650010
- Acronym / sponsor ID
- Tarus
- Conditions
- Ankle Arthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,066 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 11 May 2016 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 28 Aug 2018 (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.
This retrospective and prospective study intends to evaluate the epidemiology and effectiveness of ankle joint surgery in patients operated from January 2011 to March 2026, evaluating the results both clinically and radiographically.
Detailed description
The aim of this study is to evaluate radiographically and clinically using clinical and radiographic outcomes . Few studies exist in the literature and rarely report fix-bearing and mobile-bearing prosthetics [1-4]. Therefore the data related to this study can be considered a reference in the literature.
Patients who performed and will perform ankle prosthesis surgery from January 2011 to March 2026 and who underwent a clinical evaluation (also using questionnaires and scores) and radiographic evaluation.
The clinical data and radiological parameters were collected together with the visits and the procedures prescribed according to the clinical routine of the department.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1066 patients who underwent total ankle replacement
Key inclusion criteria (3 listed)
- Males and females
- age ≥ 18 years at the time of surgery
- patients who underwent ankle replacement surgery from January 2011 to March 2026
Key exclusion criteria (1 listed)
- age < 18 years at the time of surgery
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 |
|---|---|---|
| Total ankle replacementtotal ankle prosthesis through a lateral or an anterior approach | Procedure or surgery | – |
Primary outcome
Changes in American orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score
Time frame: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively
The American orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient (to assess sagittal motion, hindfoot motion, ankle-hindfoot stability and alignment of the ankle-hindfoot). The scale includes nine items that can be divided into three subscales (pain, function and alignment). Pain consists of one item with a maximal score of 40 points, indicating no pain. Function consists of seven items with a maximal score of 50 points, indicating full function. Alignment consists of one item with a maximal score of 10 points, indicating good alignment. The maximal score is 100 points, indicating no symptoms or impairments.
Changes in Short form 12 (SF 12)
Time frame: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively
The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey (Ware, Kosinski, and Keller, 1996). The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Anterior distal tibial angle
Time frame: Pre operatively
(ADTA: normal value 83.0 ± 3.6 degrees). The angle is subtended by the anatomic axis of the tibia and the line connecting the distal points on the anterior and posterior tibial articular surface on the anterior side (Figure 1). The tibia axis was defined as the line connecting the centres of two circles designed over the proximal and the distal tibia adjusting their radius to the anterior and posterior tibial cortices.
Changes in beta angle
Time frame: 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively
β-angle (normal value 85.0 ± 2.0 degrees). This angle is subtended anteriorly by the longitudinal axis of the tibia and the articular surface of the tibial component on the lateral view
Changes in alpha angle
Time frame: 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively
the α-angle is formed by the angle between the anatomic axis of the tibia and the articular surface of the tibial component on the AP view (normal value 90.0 ± 2.0 degrees)
Medial distal tibial angle
Time frame: Pre operatively
It is the angle between the anatomic axis of the tibia and the line connecting the distal point on the medial and lateral articular surface. (normal value 92.4 ± 3.1 degrees).
1 secondary outcome
Changes in visual analogue scale
Time frame: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively
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 28 Aug 2018.
- 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.
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 Arthritis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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: looking for participants now, as of the sponsor's last update on 28 Aug 2018. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in American orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score (time frame: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively). 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 28 Aug 2018.