Ankle Joint Replacement Outcomes Study - Full Text View

Sponsored by:	Tornier
Information provided by:	Tornier
ClinicalTrials.gov Identifier:	NCT00503438

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis Rheumatoid Arthritis Post-Traumatic Arthritis Septic Arthritis Prior Ankle Fusion	Device: ankle joint replacement	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study

Resource links provided by NLM:

MedlinePlus related topics: Anatomy Foot Health Osteoarthritis Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Tornier:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	July 2007
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Salto Talaris Anatomic Ankle total joint prosthesis

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503438

Contacts

Contact: Elaine C Mattheus, RN, BSN

888-867-6437

elainem@tornier.com

Locations

United States, New Jersey
University of Medicine and Dentisty of New Jersey	Recruiting
Newark, New Jersey, United States, 07103
Contact: Sheldon Lin, M.D. 973-972-2184
Principal Investigator: Sheldon Lin, M.D.
Sub-Investigator: Wayne Berberian, M.D.
United States, Oklahoma
The Orthopaedic Center	Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Darnell Blackmon, M.D. 918-582-6800
Principal Investigator: Darnell Blackmon, M.D.
United States, Texas
Foot and Ankle Center of South Texas	Recruiting
San Antonio, Texas, United States, 78205
Contact: Mark Casillas, MD 210-224-2655
Principal Investigator: Mark M. Casillas, M.D.
The University of Texas Medical Branch	Recruiting
Galveston, Texas, United States, 77555
Contact: Vinod Panchbhavi, M.D. 409-747-5700
Principal Investigator: Vinod Panchbhavi, M.D.
United States, Wisconsin
Medical College of Wisconsin	Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Jamie Silkey, PA-C 414-805-0140
Principal Investigator: Richard Marks, MD

Sponsors and Collaborators

Tornier

Investigators

Study Director:

Mark M Casillas, M.D.

The San Antonio Orthopaedic Group

More Information

Publications:

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.

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.

Wood PL, Deakin S. Total ankle replacement. The results in 200 ankles. J Bone Joint Surg Br. 2003 Apr;85(3):334-41.

Responsible Party:	Tornier ( Elaine Mattheus, RN, Dir. Clinical Research )
Study ID Numbers:	2006.ST01US
Study First Received:	July 17, 2007
Last Updated:	February 10, 2009
ClinicalTrials.gov Identifier:	NCT00503438 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Tornier:

Arthritis
Osteoarthritis
Arthroplasty

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Arthritis, Infectious

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Arthritis, Infectious
Infection

ClinicalTrials.gov processed this record on July 06, 2009