Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ankle Joint Replacement Outcomes Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00503438
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This post market outcome study will look at the therapeutic results of the 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 or disease Intervention/treatment Phase
Osteoarthritis Rheumatoid Arthritis Post-Traumatic Arthritis Septic Arthritis Prior Ankle Fusion Device: Salto Talaris Ankle Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study
Actual Study Start Date : October 31, 2007
Actual Primary Completion Date : June 7, 2021
Actual Study Completion Date : June 7, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Survivorship of Salto Talaris Ankle Implant [ Time Frame: 10 years ]
    Count of participants without a failed ankle arthroplasty. Ankle arthroplasty will be considered as failed if the implant is revised or removed and the ankle fused.


Secondary Outcome Measures :
  1. The American Orthopaedic Foot and Ankle Society (AOFAS) Score [ Time Frame: Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years ]
    AOFAS ankle evaluation form is a commonly used standardized assessment of foot and ankle function divided into three anatomic regions. The scale used for this study will be the Ankle-Hindfoot Scale that ranges from 0 to 100. A score of 100 points is the maximum for a patient presenting in excellent condition. The score decreases as pain, limited range of motion, daily activities, joint instability, and alignment are assessed.


Other Outcome Measures:
  1. The Foot Function Index (FFI) [ Time Frame: Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years ]
    FFI is a specialized questionnaire answered by the patient. The questionnaire consists of three parts used to report clinical scores for the domains of activity limitation, function, and disability in patients with foot and ankle conditions. Each item rated on a 0 - 10 Likert scale. 0 represents no pain/disability, and 10 represents the worst pain imaginable/severe disability for each item. Higher scores indicate decreased function.

  2. The Foot and Ankle Ability Measure (FAAM) [ Time Frame: Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years ]

    FAAM is a region-specific subject questionnaire to evaluate activities of daily living and sports. Answers for both scales are based on a Likert scale (4-0) of:

    4 - no difficulty 3 - slight difficulty 2 - moderate difficulty

    1 - extreme difficulty 0 - unable to do Patients are asked to answer each question with a single response that most clearly describes their condition. Patients are asked to mark not applicable (N/A) if the activity in question is limited by something other than their foot or ankle. A higher score indicates a higher level of physical function.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503438


Locations
Layout table for location information
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
Smith & Nephew, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Richard Marks Medical College of Wisconsin
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT00503438    
Other Study ID Numbers: T-STAS-001
First Posted: July 18, 2007    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: January 2022
Keywords provided by Smith & Nephew, Inc.:
Arthritis
Osteoarthritis
Arthroplasty
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis, Infectious
Arthritis
Osteoarthritis
Joint Diseases
 Musculoskeletal Diseases
Rheumatic Diseases
Infections