Ankle Joint Replacement Outcomes Study

Smith & Nephew, Inc.76 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Osteoarthritis Rheumatoid Arthritis Post-Traumatic Arthritis Septic Arthritis Prior Ankle Fusion

Interventions

Salto Talaris AnkleDEVICE

Salto Talaris Anatomic Ankle total joint prosthesis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Foot and Ankle Center of South Texas

San Antonio, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Survivorship of Salto Talaris Ankle Implant

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.

Time frame: 10 years

Secondary Outcomes

The American Orthopaedic Foot and Ankle Society (AOFAS) Score

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.

Time frame: Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

Data from ClinicalTrials.gov

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