Health TrialsbyHealthPanel

Clinical and Radiological Evaluation of Total Ankle Replacement (ProtesiTT)

ConditionOrthopedic Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

patients without radiographic follow-up

Trial population

patients treated with ankle replacement for osteoarthritis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ankle replacement

    Device

    Total ankle arthroplasty

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

survivorship

Survival of the implants after 10 years which is based on removal of the components and will be assessed using the Kaplan Meier Method

Time frame
10 years

Secondary outcomes

1

angle a

radiographic outcome

Time frame
10 years
2

angle b

radiographic Outcome

Time frame
10 years
3

angle y

radiographic Outcome

Time frame
10 years
4

offset ratio

radiographic Outcome

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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