Ankle Joint Replacement Outcomes Study - Tabular View

Tracking Information

First Received Date ^ICMJE

July 17, 2007

Last Updated Date

November 4, 2009

Start Date ^ICMJE

July 2007

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Survivorship [ Time Frame: 5+ years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Survivorship [ Time Frame: 5+ years ]

Change History

Complete list of historical versions of study NCT00503438 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

American Orthopaedic Foot and Ankle Society ankle evaluation, Foot Function Index (FFI), Foot and Ankle Ability Measure (FAAM) [ Time Frame: 5+ years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

American Orthopaedic Foot and Ankle Society ankle evaluation, Foot Function Index (FFI), Foot and Ankle Ability Measure (FAAM) [ Time Frame: 5+ years ]

Descriptive Information

Brief Title ^ICMJE

Ankle Joint Replacement Outcomes Study

Official Title ^ICMJE

Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study

Brief Summary

The purpose of this multi-center study is to look at the results of the Salto Talaris ankle implant as scored by functional outcome and quality of life data. This information will be used to validate and improve the implant, instruments, and surgical technique as well as increase acceptance of the procedure by insurance carriers. Our hypothesis is that the ankle joint replacement will result in better disease-specific quality of life.

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Osteoarthritis
Rheumatoid Arthritis
Post-Traumatic Arthritis
Septic Arthritis
Prior Ankle Fusion

Intervention ^ICMJE

Device: ankle joint replacement

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

June 2012

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

Pregnant women
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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00503438

Responsible Party

Kevin Ohashi, Ph.D., Sr. Dir., Biologics & Clinical Strategy, Tornier

Study ID Numbers ^ICMJE

2006.ST01US

Study Sponsor ^ICMJE

Tornier

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Mark M Casillas, M.D.

The San Antonio Orthopaedic Group

Information Provided By

Tornier

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP