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ClinicalTrials.gov Identifier: NCT01366872
Recruitment Status :
First Posted : June 6, 2011
Results First Posted : December 20, 2012
Last Update Posted : December 20, 2012
Orthopaedic Associates of Michigan, PC
Information provided by (Responsible Party):
John G. Anderson, MD, Orthopaedic Associates of Michigan, PC
This is a research study which is being done to determine the outcomes following Agility LP ankle replacement. This implant was approved by the FDA in 2007 and has been used since then with good early results. You are being asked to volunteer for this study because you have undergone Total Ankle Arthroplasty with Agility LP prosthesis. The purpose of the study is to compare the range of motion, level of pain and function during daily living prior to and after your ankle surgery.
Condition or disease
Rheumatoid Arthritis of AnkleOsteoarthritis of AnkleTraumatic Arthritis of Ankle
Assessment of Functional Outcomes Following Agility LP Ankle Replacement [ Time Frame: A Minimum of 2 Years Post Index Procedure ]
Range of Motion - Combined total of dorsiflexion and plantarflexion. Full range of motion is described as 30 degrees or more. Partial limitation is described as 29 to 15 degrees. Range of motion that is less than 15 degrees is described as severely limited.
Secondary Outcome Measures :
Evaluation of Complication and Reoperation Rates [ Time Frame: A Minimum of 2 Years Post Index Procedure ]
Number of reported complications/reoperations following the index procedure.
Radiographic Predictors of Implant Failures and Poor Outcomes [ Time Frame: A Minimum of 2 Years Post Index Procedure ]
Post-Operative radiographic disposition. Subsidence is described as the component sinking into the bone. Ingrowth is described as the implant components to conform into the tibia and talus.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Female and male subjects over the age of 18 at the time of procedure who have undergone ankle joint replacement using the DePuy Agility LP Device.
Over 18 years old
Can comprehend and sign the informed consent
Patient must have undergone Agility LP ankle replacement between January 2006 to June 2008
Patient has had following procedures on the study limb within two years of TAA
Revision of TAA
Agility LP arthroplasty was done as a revision procedure for a failed TAA or as a takedown of ankle fusion.
Any condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.