Ireland
--:--IST
Recruiting Observational

Clinical and Radiological Evaluation of Total Ankle Replacement (ProtesiTT)

NCT07168330 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2017-07-01
Last updated
2025-09-17

Condition(s) studied

Orthopedic Disorder

Investigational drug(s) / intervention(s)

Ankle replacement

Ankle replacement: Total ankle arthroplasty

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • survivorship — 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

Trial sites (1)

FacilityCityRegionStatus
IRCCS Galeazzi Milan Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07168330 on ClinicalTrials.gov ↗ ← All trials in Italy