CompletedNot Applicable

Agility LP Ankle Arthroplasty Outcomes

United States50 participantsStarted 2010-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of Functional Outcomes Following Agility LP Ankle Replacement

Timeframe: A Minimum of 2 Years Post Index Procedure

Trial details

NCT IDNCT01366872

SponsorOrthopaedic Associates of Michigan, PC

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-08

Results submitted2012-10-16

View on ClinicalTrials.gov More Rheumatoid Arthritis of Ankle trials