Agility LP Ankle Arthroplasty Outcomes
Agility LP Ankle Arthroplasty: Clinical and Radiographic Outcomes
1 other identifier
observational
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 2, 2011
CompletedFirst Posted
Study publicly available on registry
June 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
December 20, 2012
CompletedDecember 20, 2012
November 1, 2012
1.7 years
June 2, 2011
October 16, 2012
November 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of Functional Outcomes Following Agility LP Ankle Replacement
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.
A Minimum of 2 Years Post Index Procedure
Secondary Outcomes (2)
Evaluation of Complication and Reoperation Rates
A Minimum of 2 Years Post Index Procedure
Radiographic Predictors of Implant Failures and Poor Outcomes
A Minimum of 2 Years Post Index Procedure
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Patient has had following procedures on the study limb within two years of TAA
- Revision of TAA
- Ankle arthrodesis
- Amputation
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, 49525, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. John G. Anderson
- Organization
- Orthopaedic Associates of Michigan, PC
Study Officials
- PRINCIPAL INVESTIGATOR
John G Anderson, MD
Orthopaedic Associates of Michigan, PC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 2, 2011
First Posted
June 6, 2011
Study Start
December 1, 2010
Primary Completion
August 1, 2012
Study Completion
September 1, 2012
Last Updated
December 20, 2012
Results First Posted
December 20, 2012
Record last verified: 2012-11