Early MOtion Total Ankle Artroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIstituto Ortopedico Rizzoli
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
intraoperative complications (for example a malleolar fracture) which require a different post-operative protocol
peripheral vascular disease
Trial design
Design model
Parallel
Treatments tested in this trial
early mobilizzation of the ankle
Procedure/Surgeryperform flexion-extension exercises of the operated ankle
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Mobilizzazione PrecoceExperimental treatment 1 intervention
Group B: Immobilizzazione Con Stivaletto GessatoActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
AOFAS score
The American Orthopedic Foot and Ankle Society Score is a semi-objective rating scale that evaluates ankle pain, motion and alignment and ranges from 0 to 100 points. 0 worst possible score, 100 best possible score
Time frame
3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery2
MOXFQ
The MOXFQ is a 16-item instrument answered on a five-point Likert scale (each item is scored from 0 to 4, with 4 denoting 'most severe'). Scores for each item are summed to form three separate subscales representing underlying domains: walking/standing problems (seven items), foot pain (five items), and issues related to social interaction (four items). Raw scale scores are then each converted to a metric from 0 to 100, where 100 denotes the most severe.
Time frame
3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery3
SF-36 Questionnaire o Short Form-36 Health Survey
The 36-Item Short Form Health Survey (SF-36) is a popular questionnaire for measuring the self- erception of quality of life in a given population of interest. Processing the answers of a participant comprises the calculation of 10 scores corresponding to 8 scales measuring several aspects of perceived health and 2 summary components (physical and mental)The scores range from 0 point (best) to 100 (worst).
Time frame
3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery4
VAS
A Visual Analogue Scale (VAS) is a pain rating scales and ranges from 0 to 10 points
Time frame
3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgerySponsors and contacts
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Source ClinicalTrials.gov