Ankle Joint Replacement Outcomes Study

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Integra LifeSciences Corporation Identifier:
First received: July 17, 2007
Last updated: April 5, 2016
Last verified: April 2016
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
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:

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.

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

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 identifier: NCT00503438

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
Principal Investigator: Richard Marks Medical College of Wisconsin
  More Information

Responsible Party: Integra LifeSciences Corporation 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:

Additional relevant MeSH terms:
Arthritis, Infectious
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on May 24, 2016