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Agility LP Ankle Arthroplasty Outcomes

NCT ID: NCT01366872

Last Updated: 2012-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis of Ankle Osteoarthritis of Ankle Traumatic Arthritis of Ankle

Keywords

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ankle arthritis total ankle arthroplasty Agility LP,

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Orthopaedic Associates of Michigan, PC

OTHER

Sponsor Role lead

Responsible Party

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John G. Anderson, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John G Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Associates of Michigan, PC

Locations

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Orthopaedic Associates of Michigan, PC

Grand Rapids, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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OAM-LP-2010

Identifier Type: -

Identifier Source: org_study_id