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Completed

NCT Number: NCT01366872

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.

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Key information

Conditions

Rheumatoid Arthritis of Ankle Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis of Ankle Traumatic Arthritis of Ankle

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopaedic Associates of Michigan, PC

Grand Rapids, Michigan, 49525, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Assessment of Functional Outcomes Following Agility LP Ankle Replacement

    Time frame: 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 outcomes

  1. Evaluation of Complication and Reoperation Rates

    Time frame: A Minimum of 2 Years Post Index Procedure

    Number of reported complications/reoperations following the index procedure.

  2. Radiographic Predictors of Implant Failures and Poor Outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Orthopaedic Associates of Michigan, PC

Other

Registry information

Official study title

Agility LP Ankle Arthroplasty: Clinical and Radiographic Outcomes

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 6, 2011
Registry last updated
Dec 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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