Status:
RECRUITING
Early MOtion Total Ankle Artroplasty
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Ankle Osteoarthritis
Ankle - Recurrent Dislocation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 join...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06525545
Start Date
October 31 2023
End Date
October 31 2027
Last Update
August 2 2024
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italia, Italy, 40135