Evaluating early movement after total ankle replacement
Official title: Comparison of Clinical and Radiological Results of Patients Undergoing Total Ankle Arthroplasty and Treated With Early Mobilization or With Cast Immobilization
Run by Istituto Ortopedico Rizzoli · NCT06525545 · Data updated 2026-11-12
This study tests whether moving around early after ankle replacement surgery helps adults recover better and have improved joint function compared to staying in a cast for three weeks.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna, Italia) |
| Status | Recruiting |
| Started | October 31, 2023 |
| Main results expected | October 31, 2025 |
| Study ends | October 31, 2027 |
| Registry record updated | August 2, 2024 |
| Trial ID | NCT06525545 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 80 with ankle osteoarthritis or related conditions who can comply with study requirements.
✕Probably not a fit
Patients with conditions such as peripheral vascular disease, marked osteoporosis, or those requiring additional surgical interventions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the clinical and radiographic outcomes of patients who undergo total ankle arthroplasty. Participants are randomly assigned to either an early mobilization protocol or a cast immobilization for three weeks post-surgery. The goal is to determine which approach leads to better recovery and joint function. The study includes adult patients aged 18 to 80 who are motivated to follow the study protocol and complete necessary follow-ups.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery times and better functional outcomes for patients undergoing total ankle arthroplasty.
How similar studies have gone: While there is limited information on similar studies, the approach of early mobilization has shown promise in other orthopedic interventions, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (aged between 18 and 80). * Male or female patients; * Signature of the informed consent for participation in the study; * Patients prepared and motivated to comply with the scheduled follow-up visits and the completion of the study questionnaires Exclusion Criteria: * main diagnosis other than osteoarthritis, history of ankle infection * need to carry out surgical interventions associated with total prosthesis ankle (e.g., calcaneal osteotomy, knee lowering osteotomy). first metatarsal bone, supramalleolar osteotomy, etc.) * intraoperative complications (for example a malleolar fracture) which require a different post-operative protocol * peripheral vascular disease * marked osteoporosis of the ankle and foot * osteonecrosis of the talus * neurological disorders affecting the lower limb inability to understand study information or respond to questionnaires due to cognitive or linguistic deficits * patients who are pregnant or breastfeeding
Where it's running
-
Istituto Ortopedico Rizzoli
Bologna, Italia, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.