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Ankle Joint Replacement Outcomes Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tornier
ClinicalTrials.gov Identifier:
NCT00503438
First received: July 17, 2007
Last updated: May 6, 2013
Last verified: May 2013
  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:


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 2014
Estimated Primary Completion Date: June 2014 (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
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, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Tornier
  More Information

Publications:
Responsible Party: Tornier
ClinicalTrials.gov Identifier: NCT00503438     History of Changes
Other Study ID Numbers: 2006.ST01US
Study First Received: July 17, 2007
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tornier:
Arthritis
Osteoarthritis
Arthroplasty

Additional relevant MeSH terms:
Arthritis
Arthritis, Infectious
Arthritis, Rheumatoid
Osteoarthritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Infection
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014