Osteoarthritis, Post-Traumatic Arthritis, Prior Ankle Fusion, Rheumatoid Arthritis, Septic Arthritis
Conditions
Keywords
Arthritis, Osteoarthritis, Arthroplasty
Brief summary
This post market outcome study will look at the therapeutic results of the Salto Talaris Anatomic ankle prosthesis. The study population will consist of patients who will undergo an ankle arthroplasty procedure with a Salto Talaris ankle implant. An analysis will be conducted of the results, complications and revisions of this prosthesis based on the etiology for which the ankle arthroplasty was performed.
Detailed description
This is a prospective, multi-center study that will capture the therapeutic results of the Salto Talaris Anatomic ankle prosthesis in the treatment of various ankle afflictions.
Interventions
DEVICESalto Talaris Ankle
Salto Talaris Anatomic Ankle total joint prosthesis
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects that need an ankle joint replacement due to arthritis or failed prior fusion. * Subjects who have failed standard conservative management of their ankle condition
Exclusion criteria
* Class IV or higher anesthetic risk * Subjects who are not able to comply with the study procedures * Known contraindications to joint replacement such as active infection, complete talar necrosis, insufficient quality of bone stock, ligament laxity, severe osteopenia, Charcot's arthropathy * Unwilling to be followed for 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship of Salto Talaris Ankle Implant | 10 years | Count of participants without a failed ankle arthroplasty. Ankle arthroplasty will be considered as failed if the implant is revised or removed and the ankle fused. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The American Orthopaedic Foot and Ankle Society (AOFAS) Score | Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years | AOFAS ankle evaluation form is a commonly used standardized assessment of foot and ankle function divided into three anatomic regions. The scale used for this study will be the Ankle-Hindfoot Scale that ranges from 0 to 100. A score of 100 points is the maximum for a patient presenting in excellent condition. The score decreases as pain, limited range of motion, daily activities, joint instability, and alignment are assessed. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Foot Function Index (FFI) | Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years | FFI is a specialized questionnaire answered by the patient. The questionnaire consists of three parts used to report clinical scores for the domains of activity limitation, function, and disability in patients with foot and ankle conditions. Each item rated on a 0 - 10 Likert scale. 0 represents no pain/disability, and 10 represents the worst pain imaginable/severe disability for each item. Higher scores indicate decreased function. |
| The Foot and Ankle Ability Measure (FAAM) | Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years | FAAM is a region-specific subject questionnaire to evaluate activities of daily living and sports. Answers for both scales are based on a Likert scale (4-0) of: 4 - no difficulty 3 - slight difficulty 2 - moderate difficulty 1 - extreme difficulty 0 - unable to do Patients are asked to answer each question with a single response that most clearly describes their condition. Patients are asked to mark not applicable (N/A) if the activity in question is limited by something other than their foot or ankle. A higher score indicates a higher level of physical function. |
Countries
United States
Outcome results
None listed