Ankle Joint Replacement Outcomes Study

January 23, 2024 updated by: Smith & Nephew, Inc.

Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78205
        • Foot and Ankle Center of South Texas
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Candidates will be considered regardless of gender, race or ethnicity. The racial, gender and ethnic characteristics of the proposed patient population will reflect the demographics of the surrounding area.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survivorship of Salto Talaris Ankle Implant
Time Frame: 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.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The American Orthopaedic Foot and Ankle Society (AOFAS) Score
Time Frame: 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.
Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Foot Function Index (FFI)
Time Frame: 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.
Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
The Foot and Ankle Ability Measure (FAAM)
Time Frame: 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.
Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew, Inc.

Investigators

  • Principal Investigator: Richard Marks, Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2007

Primary Completion (Actual)

April 21, 2023

Study Completion (Actual)

April 21, 2023

Study Registration Dates

First Submitted

July 17, 2007

First Submitted That Met QC Criteria

July 17, 2007

First Posted (Estimated)

July 18, 2007

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T-STAS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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