Survival, Clinical and Radiological Outcomes of Total Ankle Arthroplasty With Lateral Transfibular Approach With a Minimum 10 Years Follow up (ZTM10)

July 27, 2026 updated by: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Ankle osteoarthritis is a disabling condition that can significantly impair patients' quality of life. Ankle arthrodesis has historically represented the gold standard for treating this condition [2], but technological advancements achieved with fourth-generation prostheses have considerably improved implant survival and clinical outcomes, making them a viable alternative. Prosthetic implants are mainly categorized into anterior and lateral access approaches; for the latter, short- and medium-term literature data are encouraging, but long-term studies (over 10 years) are lacking. The present study aims to determine whether the results recorded so far remain stable in the long term.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Ankle osteoarthritis is a disabling condition that can significantly impair the quality of life of affected patients. Ankle arthrodesis has historically represented the gold standard for treating this condition, but technological advancements achieved with fourth-generation prostheses have considerably improved implant survival and clinical outcomes, making them a viable alternative. Prosthetic implants are mainly categorized into anterior and lateral access approaches; for the latter, short- and medium-term data in the literature are encouraging, but long-term studies (over 10 years) are lacking. The present study aims to determine whether the results recorded so far remain stable in the long term.

The objective of the present study is to evaluate the long-term survival, clinical, and radiological outcomes (minimum 10-year follow-up) of total ankle replacements.

The protocol involves the collection of clinical and radiological data analyzed over the years during outpatient evaluations. Specifically, the evaluations are structured as follows:

  1. Evaluation of implant survival at a minimum 10-year follow-up and monitoring of any complications and reoperations using the COFAS Reoperation Coding System (CROCS).

  2. Evaluation of clinical outcomes using:

    1. AOFAS Questionnaire (Italian version): a specific clinical score for foot and ankle pathologies; despite its limitations, it is used in the majority of similar studies.
    2. Visual Analog Scale (VAS) for pain assessment to quantify the intensity of pain perceived by the patient.
    3. Ankle joint Range of Motion (ROM).

    All the above data will be collected at two follow-up time points: immediately preoperatively and at the latest follow-up visit (at least 10 years after surgery).

  3. Radiological evaluation using weight-bearing X-rays of the operated ankle (AP, ML, and 20° Saltzman views) taken at 6 months postoperatively and at the latest follow-up. This will allow the evaluation of:

    1. Aseptic loosening.
    2. Periprosthetic cyst formation.
    3. Implant subsidence.
    4. Heterotopic ossification.
    5. Osteoarthritis in adjacent joints.
  4. Any potential correlation between radiological and clinical data will then be evaluated.
  5. Finally, demographic and biometric parameters of the patients will be recorded (sex, age at the time of surgery, BMI), along with any associated surgical procedures performed concurrently with the total ankle replacement using a transfibular approach.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20100
        • IRCCS Ospedale Galeazzi Sant'Ambrogio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients affected by end-stage ankle osteoarthritis treated with total ankle replacement via a transfibular approach between April 2013 and April 2016 at the Galeazzi Orthopedic Institute in Milan. Follow-up visit data will be collected for the period from January 2013 to April 2026.

Description

Inclusion Criteria:

  • Adult patients who underwent total ankle replacement at the IRCCS Galeazzi-Sant'Ambrogio Hospital (formerly Galeazzi Orthopedic Institute) between April 2013 and April 2016 via a transfibular lateral approach with a Zimmer TM prosthesis implant and a minimum follow-up of 10 years

Exclusion Criteria:

  • Revision joint replacements
  • Previous tibiotalar arthrodesis
  • Inability to retrieve follow-up data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
10 years surviviorship of the implants
Time Frame: 10 years
The objective of this study is to evaluate the long-term survival, clinical, and radiological outcomes (minimum 10-year follow-up) of total ankle prostheses implanted via a transfibular approach.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 22, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CET 198-2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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