Clinical and radiological follow-up after total ankle replacement
Clinical and Radiological Evaluation in Patients With Total Ankle Replacement
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 type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT07168330 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan
- IRCCS Galeazzi — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Alberto Bianchi, MD — IRCCS Galeazzi, Foot and Ankle Department
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.