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Early MOtion Total Ankle Artroplasty (EMOTAA)

I

Istituto Ortopedico Rizzoli

Status

Enrolling

Conditions

Ankle Arthropathy
Cartilage Disease
Ankle Osteoarthritis
Ankle - Recurrent Dislocation

Treatments

Procedure: early mobilizzation of the ankle

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

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

Enrollment

72 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

Mobilizzazione Precoce
Experimental group
Description:
early motion of the ankle
Treatment:
Procedure: early mobilizzation of the ankle
Immobilizzazione Con Stivaletto Gessato
Active Comparator group
Description:
standard treatment
Treatment:
Procedure: early mobilizzation of the ankle

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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