Ankle Joint Replacement Outcomes Study

Rheumatoid Arthritis Clinical Trial

Official title:

Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503438
• Other study ID #: T-STAS-001
• Status: Completed
• Start date: October 31, 2007
• Est. completion date: April 21, 2023

Study information

• Verified date: January 2024
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 21, 2023
• Est. primary completion date: April 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Infectious
• Osteoarthritis
• Post-Traumatic Arthritis
• Prior Ankle Fusion
• Rheumatoid Arthritis
• Septic Arthritis

Intervention

Device:
• Salto Talaris Ankle
Salto Talaris Anatomic Ankle total joint prosthesis

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Foot and Ankle Center of South Texas	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bonnin M, Judet T, Colombier JA, Buscayret F, Graveleau N, Piriou P. Midterm results of the Salto Total Ankle Prosthesis. Clin Orthop Relat Res. 2004 Jul;(424):6-18. doi: 10.1097/01.blo.0000132407.75881.a0. — View Citation

Pyevich MT, Saltzman CL, Callaghan JJ, Alvine FG. Total ankle arthroplasty: a unique design. Two to twelve-year follow-up. J Bone Joint Surg Am. 1998 Oct;80(10):1410-20. — View Citation

Wood PL, Deakin S. Total ankle replacement. The results in 200 ankles. J Bone Joint Surg Br. 2003 Apr;85(3):334-41. doi: 10.1302/0301-620x.85b3.13849. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Foot Function Index (FFI)	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.	Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Other	The Foot and Ankle Ability Measure (FAAM)	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.	Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Primary	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.	10 years
Secondary	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.	Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years