Clinical and Radiological Evaluation of Total Ankle Replacement (ProtesiTT) (ProtesiTT)

September 11, 2025 updated by: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Clinical and Radiological Evaluation in Patients With Total Ankle Replacement

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients treated with ankle replacement for osteoarthritis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
angle a
Time Frame: 10 years
radiographic outcome
10 years
angle b
Time Frame: 10 years
radiographic Outcome
10 years
angle y
Time Frame: 10 years
radiographic Outcome
10 years
offset ratio
Time Frame: 10 years
radiographic Outcome
10 years
AOFAS score
Time Frame: 10 years
Clinical Outcome; American Orthopaedic Foot and Ankle Society: from 0 (severe) to 100 (not severe)
10 years
Foot function Index
Time Frame: 10 years
Clinical outcome; from 0 (not severe) to 10 (severe)
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Alberto Bianchi, MD, IRCCS Galeazzi, Foot and Ankle Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

October 30, 2017

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 4, 2025

First Submitted That Met QC Criteria

September 4, 2025

First Posted (Estimated)

September 11, 2025

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProtesiTT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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