Ankle Joint Replacement Outcomes Study

Sponsor

Smith & Nephew, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT00503438

Collaborator

(none)

Enrollment

Locations

Arm

216

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Rheumatoid Arthritis Post-Traumatic Arthritis Septic Arthritis Prior Ankle Fusion	Device: Salto Talaris Ankle	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study

Actual Study Start Date :

Oct 31, 2007

Anticipated Primary Completion Date :

Oct 29, 2025

Anticipated Study Completion Date :

Oct 29, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Salto Talaris Ankle This is an Implant Registry of the approved Salto Talaris Ankle replacement device	Device: Salto Talaris Ankle Salto Talaris Anatomic Ankle total joint prosthesis Other Names: Salto Talaris

Arm

Intervention/Treatment

Other: Salto Talaris Ankle

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

Device: Salto Talaris Ankle

Salto Talaris Anatomic Ankle total joint prosthesis

Other Names:

Salto Talaris

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

The Foot Function Index (FFI) [Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years]
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.
The Foot and Ankle Ability Measure (FAAM) [Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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