Agility LP Ankle Arthroplasty Outcomes
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.
Rheumatoid Arthritis of Ankle
Osteoarthritis of Ankle
Traumatic Arthritis of Ankle
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Agility LP Ankle Arthroplasty: Clinical and Radiographic Outcomes|
- Assessment of Functional Outcomes Following Agility LP Ankle Replacement [ Time Frame: A Minimum of 2 Years Post Index Procedure ] [ Designated as safety issue: No ]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.
- Evaluation of Complication and Reoperation Rates [ Time Frame: A Minimum of 2 Years Post Index Procedure ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2010|
|Study Completion Date:||September 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366872
|United States, Michigan|
|Orthopaedic Associates of Michigan, PC|
|Grand Rapids, Michigan, United States, 49525|
|Principal Investigator:||John G Anderson, MD||Orthopaedic Associates of Michigan, PC|