Overview

This trial is active, not recruiting.

Conditions osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, septic arthritis, prior ankle fusion
Treatment salto talaris ankle
Phase phase 4
Sponsor Wright Medical Group
Start date July 2007
End date December 2016
Trial size 200 participants
Trial identifier NCT00503438, 2006.ST01US

Summary

This post market outcome study will look at the therapeutic results of Tornier's FDA 510(k) cleared 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
This is an Implant Registry of the approved Salto Talaris Ankle replacement device
salto talaris ankle Salto Talaris
Salto Talaris Anatomic Ankle total joint prosthesis

Primary Outcomes

Measure
Survivorship
time frame: 5+ years

Secondary Outcomes

Measure
American Orthopaedic Foot and Ankle Society ankle evaluation, Foot Function Index (FFI), Foot and Ankle Ability Measure (FAAM)
time frame: 5+ years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study
Principal investigator Richard Marks
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Wright Medical Group.