NCT07168330

Clinical and Radiological Evaluation of Total Ankle Replacement (ProtesiTT)

Clinical and Radiological Evaluation in Patients With Total Ankle Replacement

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Orthopedic Disorder

Interventions

Type	Name	Description
DEVICE	Ankle replacement	Total ankle arthroplasty

Timeline

• Start date: 2017-07-01
• Primary completion: 2017-10-30
• Completion: 2027-12-31
• First posted: 2025-09-11
• Last updated: 2025-09-17

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study