Early MOtion Total Ankle Artroplasty
Recruiting · NCT06525545 · Interventional (participants receive a specific treatment) · Lead sponsor: Istituto Ortopedico Rizzoli
View the official record on ClinicalTrials.gov →Interventions studied
early mobilizzation of the ankle
What this trial is about
Evaluate the clinical and radiographic results of patients undergoing total ankle arthroplasty and treated in the post-operative period in a randomized manner with early mobilization of the ankle joint or with cast immobilization for 3 weeks
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Istituto Ortopedico Rizzoli - Bologna, Italia, Italy