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NCT Number: NCT07732153

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale Galeazzi Sant'Ambrogio

Milan, 20100, Italy

About this study

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:

  • 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).
  • Evaluation of clinical outcomes using:
  • 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.
  • Visual Analog Scale (VAS) for pain assessment to quantify the intensity of pain perceived by the patient.
  • 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).

  • 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:
  • Aseptic loosening.
  • Periprosthetic cyst formation.
  • Implant subsidence.
  • Heterotopic ossification.
  • Osteoarthritis in adjacent joints.
  • Any potential correlation between radiological and clinical data will then be evaluated.
  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Other

Registry information

Acronym: ZTM10

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.