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| Sponsored by: |
DePuy Orthopaedics |
| Information provided by: | DePuy Orthopaedics |
| ClinicalTrials.gov Identifier: | NCT00561847 |
Purpose
The purpose of this prospective, randomized, multi-center, single blind, controlled clinical investigation is to determine the safety and efficacy of the cementless Mobility™ Total Ankle System compared to the cemented Agility™ LP Total Ankle Prosthesis (510 (k) K053569).
| Condition | Intervention | Phase |
|
Ankle Arthritis |
Device: Total ankle replacement Device: total ankle replacement |
Phase II Phase III |
| MedlinePlus related topics: | Foot Health |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment |
| Official Title: | Prospective, Randomized, Multi-Center, Trial of Mobility™ Total Ankle Prosthesis |
| Estimated Enrollment: | 540 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | January 2010 |
| Arms | Assigned Interventions |
|
A: Experimental
This arm is the Mobility™ Total Ankle System, a three-component, cementless, unconstrained, mobile-bearing prosthesis with a dedicated instrumentation system.
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Device: Total ankle replacement
The Mobility™ Total Ankle System is a three-component, cementless, unconstrained, mobile-bearing prosthesis with a dedicated instrumentation system.
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B: Active Comparator
This arm is the Agility™ LP Total Ankle Prosthesis, a cemented, semi-constrained prosthesis with a dedicated instrumentation system.
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Device: total ankle replacement
The Agility™ LP Total Ankle Prosthesis is a cemented, semi-constrained prosthesis with a dedicated instrumentation system.
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The study is designed as a prospective, randomized, controlled, single-blind study to address the safety and efficacy of the investigational Mobility™ Total Ankle System, a three-component, cementless, unconstrained, mobile-bearing prosthesis with a dedicated instrumentation system. The study is designed to compare the investigational device with a control device comprised of the Agility™ LP Total Ankle Prosthesis, a cemented, semi-constrained prosthesis with a dedicated instrumentation system. The Agility™ LP was selected as the control device because it is one of the few approved ankle prostheses in the United States, and is a modification of the most widely used ankle arthroplasty system in the United States (Agility™ Total Ankle Prosthesis K920802). Arthroplasty was chosen over arthrodesis because although both techniques reduce pain and restore alignment, arthroplasty also replaces motion of the ankle joint, which has a substantial effect on clinical outcomes. The success of the ankle prostheses will be based on a combination of clinical, radiographic, and survivorship assessments at 24 months after surgery.
The Mobility™ investigational device consists of three components, tibial, bearing, and talar. The Agility™ LP Total Ankle Prosthesis is a modular ankle prosthesis that is comprised of a tibial tray, a polyethylene tibial insert and a talar component as described in 510(k) K053569. It is available for cemented use only.
Eligibility
| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Brian Koser | 574-371-4921 | BKoser@dpyus.jnj.com |
| United States, Alabama | |||||
| Alabama Sports Medicine & Orthopaedic Center | Not yet recruiting | ||||
| Birmingham, Alabama, United States, 355205 | |||||
| United States, Illinois | |||||
| Glenview Medical Arts Building | Not yet recruiting | ||||
| Glenview, Illinois, United States, 60025 | |||||
| United States, Maryland | |||||
| Institute for Foot and Ankle | Recruiting | ||||
| Baltimore, Maryland, United States, 21202 | |||||
| United States, Massachusetts | |||||
| Brigham and Women's Hospital | Not yet recruiting | ||||
| Boston, Massachusetts, United States, 02130 | |||||
| United States, Minnesota | |||||
| Minnesota Sports Medicine and OCPA | Recruiting | ||||
| Eden Prairie, Minnesota, United States, 55344 | |||||
| United States, Ohio | |||||
| Orthopaedic Foot & Ankle | Recruiting | ||||
| Columbus, Ohio, United States, 43231-8608 | |||||
| United States, Pennsylvania | |||||
| Pennsylvania Orthopaedic Foot & Ankle Surgeons | Not yet recruiting | ||||
| Philadelphia, Pennsylvania, United States, 19106 | |||||
| Human Motion Center | Recruiting | ||||
| Pittsburgh, Pennsylvania, United States, 15212 | |||||
| United States, South Dakota | |||||
| Alvine Foot and Ankle Center | Recruiting | ||||
| Sioux Falls, South Dakota, United States, 57103 | |||||
| United States, Texas | |||||
| UT Katy Orthopaedics | Not yet recruiting | ||||
| Katy, Texas, United States, 77494 | |||||
| United States, Wisconsin | |||||
| Medical College of Wisconsin | Not yet recruiting | ||||
| Milwaukee, Wisconsin, United States, 53226-0099 | |||||
| DePuy Orthopaedics |
| Study Director: | Brian Koser | DePuy Orthopaedics, Inc. |
More Information
| Study ID Numbers: | 05062 |
| First Received: | November 20, 2007 |
| Last Updated: | November 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00561847 |
| Health Authority: | United States: Food and Drug Administration |
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