Ankle Joint Replacement Outcomes Study
Primary Purpose
Osteoarthritis, Rheumatoid Arthritis, Post-Traumatic Arthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Salto Talaris Ankle
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Arthritis, Osteoarthritis, Arthroplasty
Eligibility 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
Sites / Locations
- Foot and Ankle Center of South Texas
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Salto Talaris Ankle
Arm Description
This is an Implant Registry of the approved Salto Talaris Ankle replacement device
Outcomes
Primary Outcome Measures
Survivorship of Salto Talaris Ankle Implant
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
The American Orthopaedic Foot and Ankle Society (AOFAS) Score
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00503438
Brief Title
Ankle Joint Replacement Outcomes Study
Official Title
Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 31, 2007 (Actual)
Primary Completion Date
April 21, 2023 (Actual)
Study Completion Date
April 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Septic Arthritis, Prior Ankle Fusion
Keywords
Arthritis, Osteoarthritis, Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Salto Talaris Ankle
Arm Type
Other
Arm Description
This is an Implant Registry of the approved Salto Talaris Ankle replacement device
Intervention Type
Device
Intervention Name(s)
Salto Talaris Ankle
Other Intervention Name(s)
Salto Talaris
Intervention Description
Salto Talaris Anatomic Ankle total joint prosthesis
Primary Outcome Measure Information:
Title
Survivorship of Salto Talaris Ankle Implant
Description
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.
Time Frame
10 years
Secondary Outcome Measure Information:
Title
The American Orthopaedic Foot and Ankle Society (AOFAS) Score
Description
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.
Time Frame
Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Other Pre-specified Outcome Measures:
Title
The Foot Function Index (FFI)
Description
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.
Time Frame
Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Title
The Foot and Ankle Ability Measure (FAAM)
Description
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.
Time Frame
Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Marks
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foot and Ankle Center of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15241138
Citation
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. doi: 10.1097/01.blo.0000132407.75881.a0.
Results Reference
background
PubMed Identifier
9801209
Citation
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.
Results Reference
background
PubMed Identifier
12729104
Citation
Wood PL, Deakin S. Total ankle replacement. The results in 200 ankles. J Bone Joint Surg Br. 2003 Apr;85(3):334-41. doi: 10.1302/0301-620x.85b3.13849.
Results Reference
background
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Ankle Joint Replacement Outcomes Study
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