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NCT Number: NCT07168330

Clinical and Radiological Evaluation of Total Ankle Replacement (ProtesiTT)

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

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Key information

Conditions

Orthopedic Disorder Musculoskeletal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ankle replacement

Device

Total ankle arthroplasty

Primary outcomes

  1. survivorship

    Time frame: 10 years

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

Secondary outcomes

  1. angle a

    Time frame: 10 years

    radiographic outcome

  2. angle b

    Time frame: 10 years

    radiographic Outcome

  3. angle y

    Time frame: 10 years

    radiographic Outcome

  4. offset ratio

    Time frame: 10 years

    radiographic Outcome

  5. AOFAS score

    Time frame: 10 years

    Clinical Outcome; American Orthopaedic Foot and Ankle Society: from 0 (severe) to 100 (not severe)

  6. Foot function Index

    Time frame: 10 years

    Clinical outcome; from 0 (not severe) to 10 (severe)

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Clinical and Radiological Evaluation in Patients With Total Ankle Replacement

Acronym: ProtesiTT

Important dates

Study start
2017
Primary completion
2017
Study completion
2027
First posted
Sep 11, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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