Osteoarthritis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Adults between 35 and 75 years of age (male or female)
- People who have a condition affecting the ankle joint (where the shin bone meets the ankle bone) that doctors have determined requires surgery to replace the joint with a prosthetic (artificial) implant
- People with severe loss of bone or significant damage to the ankle bone (talus)
- People whose custom implant is made at the Rizzoli Orthopaedic Institute
- People who have signed a consent form agreeing to take part in the study
- People who are willing and able to attend pre- and post-surgery appointments, follow rehabilitation programmes, attend follow-up visits, and complete study questionnaires
Who may not be able to join:
- People who are unable to understand the study information or provide formal consent to participate
- Women who are pregnant or able to become pregnant
- People with a Body Mass Index (BMI) over 40 (a measure of body weight relative to height)
- People who decline to sign the study consent form
- People with substance use issues or psychological conditions that may make it difficult to follow the rehabilitation or post-surgery assessment programme
- People with a known allergy or sensitivity to any of the materials used in the implant device
- People who have an active infection, or a suspected hidden infection, in or around the ankle joint being treated
- People who have had orthopaedic surgery on their legs within the past year, or who have other orthopaedic surgery planned within the next year (not including the ankle replacement itself)
- People with nerve or muscle conditions that limit the ability to properly assess how safe or effective the device is
- People diagnosed with a systemic disease (such as lupus) or a metabolic bone disorder (such as Paget's disease) that causes ongoing bone deterioration
- People who are on immune-suppressing medications or have taken high-dose steroid treatment for an extended period (for example, more than 30 days) (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: +39 349 879 8863
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
To evaluate the survival of the FAR implant in a cohort of patients treated at the Orthopaedic and Traumatology Clinic I of the Rizzoli Orthopaedic Institute, with follow-up at 1, 3, 6, 12, 24, and 36 months.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.