Ankle Joint Replacement Outcomes Study

Completed

• Conditions: Osteoarthritis; Rheumatoid Arthritis; Prior Ankle Fusion; Septic Arthritis; Post-Traumatic Arthritis
• Interventions: Device: Salto Talaris Ankle

• Registration Number: NCT00503438
• Lead Sponsor: Smith & Nephew, Inc.

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.

Study Timeline

• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-18
• Study Start: 2007-10-31
• Primary Completion: 2023-04-21
• Study Completion: 2023-04-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Foot and Ankle Center of South Texas; 🇺🇸 San Antonio, Texas, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States