Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Smith & Nephew, Inc.
- Enrollment
- 76
- Locations
- 2
- Primary Endpoint
- Survivorship of Salto Talaris Ankle Implant
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Survivorship of Salto Talaris Ankle Implant
Time Frame: 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 Outcomes
- 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)