Ankle Joint Replacement Outcomes Study

Smith & Nephew

Status: Completed

Conditions: Prior Ankle Fusion; Osteoarthritis; Septic Arthritis; Post-Traumatic Arthritis; Rheumatoid Arthritis

Treatments: Device: Salto Talaris Ankle

Study type: Observational

Funder types: Industry

Identifiers

NCT00503438

T-STAS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

76 participants in 1 patient group

Salto Talaris Ankle

Description:

This is an Implant Registry of the approved Salto Talaris Ankle replacement device

Treatment:

Device: Salto Talaris Ankle