Ankle Joint Replacement Outcomes Study
The purpose of this multi-center study is to look at the results of the Salto Talaris ankle implant as scored by functional outcome and quality of life data. This information will be used to validate and improve the implant, instruments, and surgical technique as well as increase acceptance of the procedure by insurance carriers. Our hypothesis is that the ankle joint replacement will result in better disease-specific quality of life.
| Condition | Intervention | Phase |
|---|---|---|
| Osteoarthritis Rheumatoid Arthritis Post-Traumatic Arthritis Septic Arthritis Prior Ankle Fusion |
Device: ankle joint replacement | Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study |
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 2012 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
- Device: ankle joint replacement
Salto Talaris Anatomic Ankle total joint prosthesis
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:
- Pregnant women
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503438
| United States, New Jersey | |
| University of Medicine and Dentisty of New Jersey | Recruiting |
| Newark, New Jersey, United States, 07103 | |
| Contact: Sheldon Lin, M.D. 973-972-2184 | |
| Principal Investigator: Sheldon Lin, M.D. | |
| Sub-Investigator: Wayne Berberian, M.D. | |
| United States, Oklahoma | |
| The Orthopaedic Center | Recruiting |
| Tulsa, Oklahoma, United States, 74104 | |
| Contact: Darnell Blackmon, M.D. 918-582-6800 | |
| Principal Investigator: Darnell Blackmon, M.D. | |
| United States, Texas | |
| The University of Texas Medical Branch | Recruiting |
| Galveston, Texas, United States, 77555 | |
| Contact: Vinod Panchbhavi, M.D. 409-747-5700 | |
| Principal Investigator: Vinod Panchbhavi, M.D. | |
| Foot and Ankle Center of South Texas | Recruiting |
| San Antonio, Texas, United States, 78205 | |
| Contact: Mark Casillas, MD 210-224-2655 | |
| Principal Investigator: Mark M. Casillas, M.D. | |
| United States, Utah | |
| Intermountain Orthopedic Specialty Group – TOSH | Recruiting |
| Salt Lake City, Utah, United States, 84107 | |
| Contact: James M Morgan, MD 801-314-4900 | |
| Contact: Drew Van Boerum, MD 801-314-4900 | |
| Principal Investigator: James M. Morgan, MD | |
| Sub-Investigator: Drew Van Boerum, MD | |
| United States, Wisconsin | |
| Medical College of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Jamie Silkey, PA-C 414-805-0140 | |
| Principal Investigator: Richard Marks, MD | |
Sponsors and Collaborators
Tornier
Investigators
| Study Director: | Mark M Casillas, M.D. | The San Antonio Orthopaedic Group |
More Information
Publications:
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.
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.
Wood PL, Deakin S. Total ankle replacement. The results in 200 ankles. J Bone Joint Surg Br. 2003 Apr;85(3):334-41.
| Responsible Party: | Tornier ( Kevin Ohashi, Ph.D., Sr. Dir., Biologics & Clinical Strategy ) |
| Study ID Numbers: | 2006.ST01US |
| Study First Received: | July 17, 2007 |
| Last Updated: | November 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00503438 History of Changes |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Tornier:
| Arthritis Osteoarthritis Arthroplasty |
Additional relevant MeSH terms:
| Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Arthritis, Infectious Infection |
Source: National Institutes of Health – http://clinicaltrials.gov/ct2/show/NCT00503438