Early MOtion Total Ankle Artroplasty

Recruiting now · Not applicable

Conditions studied: Ankle Osteoarthritis, Ankle - Recurrent Dislocation, Cartilage Disease, Ankle Arthropathy

In brief

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

Key facts

Study ID

NCT06525545

Run by

Istituto Ortopedico Rizzoli

People needed

72

Starts

2023-10-31

Expected to finish

2027-10-31

Last updated by the study team

2024-08-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Istituto Ortopedico Rizzoli — Bologna, Italia, Italy (enrolling)

Full record on ClinicalTrials.gov

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