Clinical and Radiological Evaluation of Total Ankle Replacement (ProtesiTT)

NCT07168330 | Recruiting FDA Device

• 1 other identifier: ProtesiTT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• survivorship

  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 Outcomes (6)

• angle a

  10 years

• angle b

  10 years

• angle y

  10 years

• offset ratio

  10 years

• AOFAS score

  10 years

Interventions

Ankle replacement DEVICE

Total ankle arthroplasty

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients treated with ankle replacement for osteoarthritis

You may qualify if:

• 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

You may not qualify if:

• patients without radiographic follow-up

Sponsors & Collaborators

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

Study Sites (1)

IRCCS Galeazzi

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Arthroplasty, Replacement, Ankle

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Alberto Bianchi, MD

  IRCCS Galeazzi, Foot and Ankle Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: July 1, 2017
• Primary Completion: October 30, 2017
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-08

Locations

IT (1)