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| Sponsored by: |
Tornier |
|---|---|
| Information provided by: | Tornier |
| ClinicalTrials.gov Identifier: | NCT00503438 |
Purpose
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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study |
| 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) |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Elaine C Mattheus, RN, BSN | 888-867-6437 | elainem@tornier.com |
| 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 | |
| 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. | |
| 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. | |
| 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 | |
| Study Director: | Mark M Casillas, M.D. | The San Antonio Orthopaedic Group |
More Information
| Responsible Party: | Tornier ( Elaine Mattheus, RN, Dir. Clinical Research ) |
| Study ID Numbers: | 2006.ST01US |
| Study First Received: | July 17, 2007 |
| Last Updated: | February 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00503438 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Arthritis Osteoarthritis Arthroplasty |
|
Autoimmune Diseases Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Arthritis, Infectious |
|
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Arthritis, Infectious Infection |