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
:
Active, not recruiting
First Posted
: July 18, 2007
Last Update Posted
: August 1, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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) |
Estimated Enrollment : | 75 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study |
Study Start Date : | July 2007 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | December 2023 |
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
|
- Survivorship [ Time Frame: 5+ years ]
- American Orthopaedic Foot and Ankle Society ankle evaluation, Foot Function Index (FFI), Foot and Ankle Ability Measure (FAAM) [ Time Frame: 5+ years ]

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.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

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 |
Publications:
Responsible Party: | Integra LifeSciences Corporation |
ClinicalTrials.gov Identifier: | NCT00503438 History of Changes |
Other Study ID Numbers: |
2006.ST01US |
First Posted: | July 18, 2007 Key Record Dates |
Last Update Posted: | August 1, 2017 |
Last Verified: | July 2017 |
Keywords provided by Integra LifeSciences Corporation:
Arthritis Osteoarthritis Arthroplasty |
Additional relevant MeSH terms:
Arthritis Osteoarthritis Arthritis, Rheumatoid Arthritis, Infectious Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Infection |