Ankle Joint Replacement Outcomes Study

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Integra LifeSciences Corporation

ClinicalTrials.gov Identifier:

NCT00503438

First received: July 17, 2007

Last updated: April 5, 2016

Last verified: April 2016

History of Changes

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: Salto Talaris Ankle	Phase 4


Study Type:	Interventional
Study Design:	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:

Genetics Home Reference related topics: rheumatoid arthritis

MedlinePlus related topics: Arthritis Osteoarthritis

Genetic and Rare Diseases Information Center resources: Infectious Arthritis

U.S. FDA Resources

Further study details as provided by Integra LifeSciences Corporation:

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:	75
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2023
Estimated Primary Completion Date:	December 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


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

Sponsors and Collaborators

Integra LifeSciences Corporation

Investigators


Principal Investigator:	Richard Marks	Medical College of Wisconsin

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:	Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:	NCT00503438 History of Changes
Other Study ID Numbers:	2006.ST01US
Study First Received:	July 17, 2007
Last Updated:	April 5, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by Integra LifeSciences Corporation:


Arthritis Osteoarthritis Arthroplasty

Additional relevant MeSH terms:


Arthritis Osteoarthritis Arthritis, Rheumatoid Arthritis, Infectious Joint Diseases Musculoskeletal Diseases	Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Infection

ClinicalTrials.gov processed this record on September 23, 2016

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