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Clinical and Radiological Evaluation of Total Ankle Replacement (ProtesiTT)

NCT07168330 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-09-17

No results posted yet for this study

Summary

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

Conditions

  • Orthopedic Disorder

Interventions

DEVICE

Ankle replacement

Total ankle arthroplasty

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Alberto Bianchi, MD · IRCCS Galeazzi, Foot and Ankle Department

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2017-10-30
Completion
2027-12-31
FDA Device
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07168330 on ClinicalTrials.gov