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
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Rheumatoid Arthritis Post-Traumatic Arthritis Septic Arthritis Prior Ankle Fusion||Device: Salto Talaris Ankle||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
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
|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|
|Principal Investigator:||Richard Marks||Medical College of Wisconsin|