Agility LP Ankle Arthroplasty Outcomes

Agility LP Ankle Arthroplasty: Clinical and Radiographic 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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis of Ankle; Osteoarthritis of Ankle; Traumatic Arthritis of Ankle

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49525
      • Orthopaedic Associates of Michigan, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Complication and Reoperation Rates	Number of reported complications/reoperations following the index procedure.	A Minimum of 2 Years Post Index Procedure
Radiographic Predictors of Implant Failures and Poor Outcomes	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.	A Minimum of 2 Years Post Index Procedure

Collaborators and Investigators

• Sponsor: Orthopaedic Associates of Michigan, PC
• Investigators: Principal Investigator: John G Anderson, MD, Orthopaedic Associates of Michigan, PC

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: June 2, 2011
• First Submitted That Met QC Criteria: June 3, 2011
• First Posted (Estimate): June 6, 2011

Study Record Updates

• Last Update Posted (Estimate): December 20, 2012
• Last Update Submitted That Met QC Criteria: November 20, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: ankle; arthritis; total ankle arthroplasty; Agility LP,
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: OAM-LP-2010