Agility LP Ankle Arthroplasty Outcomes

Orthopaedic Associates of Michigan, PC50 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Rheumatoid Arthritis of Ankle Osteoarthritis of Ankle Traumatic Arthritis of Ankle

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Orthopaedic Associates of Michigan, PC

Grand Rapids, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: A Minimum of 2 Years Post Index Procedure

Secondary Outcomes

Evaluation of Complication and Reoperation Rates

Number of reported complications/reoperations following the index procedure.

Time frame: 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.

Time frame: A Minimum of 2 Years Post Index Procedure

Data from ClinicalTrials.gov

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