Clinical trial Recruiting at 1 site Observational Ages 18 to 90

Clinical and radiological follow-up after total ankle replacement

Official title: Clinical and Radiological Evaluation in Patients With Total Ankle Replacement

Run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · NCT07168330 · Data updated 2026-11-12

This study will see how people with ankle osteoarthritis do after getting a total ankle replacement by tracking their symptoms and X‑rays over time.

Quick facts

Study typeObservational
Ages18 Years to 90 Years
SexAll
Enrollment100 (estimated)
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Academic / other
Locations1 site (Milan)
StatusRecruiting
StartedJuly 1, 2017
Main results expectedOctober 30, 2017
Study endsDecember 31, 2027
Registry record updatedSeptember 17, 2025
Trial IDNCT07168330 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients treated with total ankle replacement for osteoarthritis who are willing and able to complete scheduled follow‑up visits, questionnaires, and radiographic examinations.

Probably not a fit

Patients who cannot attend follow‑up visits or do not have postoperative radiographic follow‑up will not be included and therefore will not benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study collecting clinical and radiographic outcomes from patients who underwent third‑generation total ankle replacement performed by non‑designer surgeons. Clinical function and pain are measured before and after surgery using the AOFAS score, the Foot Function Index, and a visual analogue scale for pain, with at least 12 months of follow‑up. Weightbearing AP and lateral ankle radiographs are collected preoperatively and at last follow‑up and are independently reviewed by an orthopedic surgeon. The design aims to provide independent, real‑world outcome data outside of implant‑designer centers.

Why it matters

Potential benefit: If results confirm good clinical and radiographic outcomes from non‑designer surgeons, this could support broader, confident use of total ankle replacement for appropriate patients.

How similar studies have gone: Previous reports of third‑generation total ankle replacements have shown outcomes comparable to ankle fusion, but many such studies were authored by implant designers so independent confirmations are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* patients treated with ankle replacement for osteoarthritis
* The patient is willing and able to complete scheduled follow-up evaluations questionnaires and radiographic examination as described in the Informed Consent

Exclusion Criteria:

* patients without radiographic follow-up

Where it's running

  • IRCCS Galeazzi
    Milan, Italy
    Recruiting

Study contacts

  • Principal investigator: Alberto Bianchi, MD — IRCCS Galeazzi, Foot and Ankle Department

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.