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Sponsored by: |
Link America, Inc. |
Information provided by: | Link America, Inc. |
ClinicalTrials.gov Identifier: | NCT00586781 |
The purpose of this study is to evaluate the safety of the S.T.A.R. device for patients with bilateral disease.
Condition | Intervention | Phase |
Osteoarthritis Post-Traumatic Arthritis Rheumatoid Arthritis |
Device: Scandinavian Total Ankle Replacement (STAR) |
Phase III |
MedlinePlus related topics: | Osteoarthritis Rheumatoid Arthritis |
ChemIDplus related topics: | Chromium Cobalt |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | Investigational Device Exemption for the Scandinavian Total Ankle Replacement (STAR) - Bilateral Arm |
Enrollment: | 21 |
Study Start Date: | September 2001 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
3: Experimental
The S.T.A.R. ankle system is the study device. The device has three parts: two metal bearing surfaces (cobalt-chromium alloy) plates with bars that fit into the bone and one plastic (polyethylene) spacer that moves between the metal plates like a ball bearing. The materials in the S.T.A.R. device are the same materials used in total hip and knee implants. Both ankles of every subject will be treated with the STAR ankle.
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Device: Scandinavian Total Ankle Replacement (STAR)
The device has three parts: two metal bearing surfaces (cobalt-chromium alloy) plates with bars that fit into the bone and one plastic (polyethylene) spacer that moves between the metal plates like a ball bearing. The materials in the S.T.A.R. device are the same materials used in total hip and knee implants.
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The specific objectives are to show that the safety data of the S.T.A.R. ankle arthroplasty is similar for treatment of single ankle disease (as defined in the pivotal study) and bilateral ankle disease. The bilateral disease may be identified at the time of enrollment or may have progressed after enrollment and treatment of the first ankle in the pivotal study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |||||
Mayo Clinic | |||||
Jacksonville, Florida, United States, 32224 | |||||
United States, Iowa | |||||
University of Iowa | |||||
Iowa City, Iowa, United States, 52242 | |||||
United States, Kansas | |||||
Kansas University Medical Center | |||||
Kansas City, Kansas, United States, 66160 | |||||
United States, North Carolina | |||||
Duke University Medical Center | |||||
Durham, North Carolina, United States, 27710 | |||||
United States, Texas | |||||
Orthopedic Associates of Dallas | |||||
Dallas, Texas, United States, 75246 |
Link America, Inc. |
Principal Investigator: | Roger A Mann, MD | Roger A Mann, Inc |
Principal Investigator: | Michael J Coughlin, MD | Foot and Ankle |
Responsible Party: | Link America, Inc ( Andrew Greenberg, President ) |
Study ID Numbers: | Link-3 |
First Received: | December 21, 2007 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00586781 |
Health Authority: | United States: Food and Drug Administration |
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