Agility LP Ankle Arthroplasty Outcomes

Completed

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

• Registration Number: NCT01366872
• Lead Sponsor: Orthopaedic Associates of Michigan, PC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-06
• Primary Completion: 2012-08
• Study Completion: 2012-09
• Results First Submitted: 2012-10-16
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-20
• Last Update Submitted: 2012-11-20
• Results First Posted: 2012-12-20
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of Functional Outcomes Following Agility LP Ankle Replacement	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

Name	Time	Method
Evaluation of Complication and Reoperation Rates	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	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.

Trial Locations

Locations (1)

Orthopaedic Associates of Michigan, PC; 🇺🇸 Grand Rapids, Michigan, United States