Osteoarthritis Trial, Recruiting NCT06193057 Sponsor: Istituto Ortopedico Rizzoli Condition: Osteoarthritis
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Osteoarthritis Trial, Recruiting

NCT06193057
Recruiting Not Applicable

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:

  • You are a man or woman between 40 and 75 years old (inclusive) with arthritis in one ankle joint, and your doctor has recommended you for a first-time total ankle replacement surgery.
  • You are willing and able to attend all required study appointments and follow-up visits.
  • You have read and signed the official consent form that has been approved by the Ethics Committee.

Who may not be able to join:

  • You are experiencing difficult social circumstances, such as homelessness or restrictions on your personal freedom.
  • You have been rated as ASA class 3 or 4, meaning you have serious or severe health conditions that affect your overall fitness for surgery (confirm with trial site).
  • You have poor blood flow returning from the veins in your legs (deep vein insufficiency).
  • You have a history of a serious skin and tissue infection called erysipelas in your legs.
  • You have a neurological condition or a disorder affecting your thinking, memory, or mental health.
  • Your ankle has a significant bone or joint misalignment of more than 15 degrees.
  • You or a close family member have a history of blood clots in the veins (DVT) or lungs (pulmonary embolism).
  • You have previously had joint replacement or joint fusion surgery on another joint in the same or opposite leg (other than the ankle being treated).
  • You are pregnant.
  • You have a rheumatic disease, such as rheumatoid arthritis.
  • Your ankle surgery would require additional procedures beyond the ankle replacement itself.

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 0516366

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

Status
Recruiting
Phase
Not Applicable
Sponsor
Istituto Ortopedico Rizzoli
Registry
ClinicalTrials.gov
Start date
26 July 2023
Est. completion
30 April 2026

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Ankle radiographic angles; Ankle radiographic angles; Ankle radiographic angles; Ankle radiographic angles; Ankle radiographic angles

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov