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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ankle replacement | Device | Total ankle arthroplasty |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| angle a | radiographic outcome | 10 years |
| angle b | radiographic Outcome | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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patients treated with ankle replacement for osteoarthritis
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Bianchi, MD | IRCCS Galeazzi, Foot and Ankle Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Galeazzi | Recruiting | Milan | Italy |
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D058737 | Arthroplasty, Replacement, Ankle |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| angle y | radiographic Outcome | 10 years |
| offset ratio | radiographic Outcome | 10 years |
| AOFAS score | Clinical Outcome; American Orthopaedic Foot and Ankle Society: from 0 (severe) to 100 (not severe) | 10 years |
| Foot function Index | Clinical outcome; from 0 (not severe) to 10 (severe) | 10 years |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |