Ankle Joint Replacement Outcomes Study - Full Text View

Sponsor:	Tornier
Information provided by (Responsible Party):	Tornier
ClinicalTrials.gov Identifier:	NCT00503438

Purpose

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.

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:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study

Resource links provided by NLM:

MedlinePlus related topics: 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 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Salto Talaris Anatomic Ankle total joint prosthesis

Other Name: Salto Talaris

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:

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

Locations

United States, Wisconsin
Medical College of Wisconsin	Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Jamie Silkey 414-805-0140
Principal Investigator: Richard Marks, MD

Sponsors and Collaborators

Tornier

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
ClinicalTrials.gov Identifier:	NCT00503438 History of Changes
Other Study ID Numbers:	2006.ST01US
Study First Received:	July 17, 2007
Last Updated:	February 7, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Tornier:

Arthritis
Osteoarthritis
Arthroplasty

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Arthritis, Infectious
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infection

ClinicalTrials.gov processed this record on February 09, 2012