Orthopedic Disorder
Conditions
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
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.
Interventions
DEVICEAnkle replacement
Total ankle arthroplasty
Sponsors
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| angle b | 10 years | radiographic Outcome |
| angle y | 10 years | radiographic Outcome |
| angle a | 10 years | radiographic outcome |
| AOFAS score | 10 years | Clinical Outcome; American Orthopaedic Foot and Ankle Society: from 0 (severe) to 100 (not severe) |
| Foot function Index | 10 years | Clinical outcome; from 0 (not severe) to 10 (severe) |
| offset ratio | 10 years | radiographic Outcome |
Countries
Italy
Outcome results
None listed