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Clinical and Radiological Evaluation of Total Ankle Replacement (ProtesiTT)

I

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status

Enrolling

Conditions

Orthopedic Disorder

Treatments

Device: Ankle replacement

Study type

Observational

Funder types

Other

Identifiers

NCT07168330
ProtesiTT

Details and patient eligibility

About

Numerous studies reported the efficacy of new third-generation of total ankle arthroplasties for the treatment of advanced ankle osteoarthritis and clinical results are comparable to ankle arthrodesis. The improvement in knowledge of ankle joint biomechanics, instrumentation, surgical approach may led to even higher clinical results in comparison to arthrodesis.

Many of the studies reporting the results of ankle replacement are provided by surgeons involved at least in the initial design of the implant. Thus, familiarity with the system can be a potential bias affecting outcomes and orthopedic surgeons may find difficulties in reproducing the results.

In this study, we will assess the clinical and radiological outcomes in patients who underwent this procedure performed by non-designer surgeons

Full description

Patients who underwent total ankle replacement will be unrolled in this study. Clinical assessment is collected pre- and post-operatively with minimum follow-up of 12 months from each patients using the American Orthopedic Foot and Ankle (AOFAS) score, the Foot Function Index and the visual analogue scale (VAS) for pain.

Weightbearing anteriorposterior and lateral radiographs of the ankle are collected pre-operatively and at the last follow-up for all of the patients and independently evaluated by an orthopedic surgeon.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients treated with ankle replacement for osteoarthritis
  • The patient is willing and able to complete scheduled follow-up evaluations questionnaires and radiographic examination as described in the Informed Consent

Exclusion criteria

  • patients without radiographic follow-up

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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