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Agility LP Ankle Arthroplasty Outcomes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John G. Anderson, MD, Orthopaedic Associates of Michigan, PC
ClinicalTrials.gov Identifier:
NCT01366872
First received: June 2, 2011
Last updated: November 20, 2012
Last verified: November 2012
History of Changes

June 2, 2011
November 20, 2012
December 2010
August 2012   (final data collection date for primary outcome measure)
Assessment of Functional Outcomes Following Agility LP Ankle Replacement [ Time Frame: A Minimum of 2 Years Post Index Procedure ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT01366872 on ClinicalTrials.gov Archive Site
  • Evaluation of Complication and Reoperation Rates [ Time Frame: A Minimum of 2 Years Post Index Procedure ] [ Designated as safety issue: No ]
    Number of reported complications/reoperations following the index procedure.
  • Radiographic Predictors of Implant Failures and Poor Outcomes [ Time Frame: A Minimum of 2 Years Post Index Procedure ] [ Designated as safety issue: No ]
    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.
Not Provided
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Agility LP Ankle Arthroplasty Outcomes
Agility LP Ankle Arthroplasty: Clinical and Radiographic 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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample

Female and male subjects over the age of 18 at the time of procedure who have undergone ankle joint replacement using the DePuy Agility LP Device.
  • Rheumatoid Arthritis of Ankle
  • Osteoarthritis of Ankle
  • Traumatic Arthritis of Ankle
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01366872
OAM-LP-2010
No
John G. Anderson, MD, Orthopaedic Associates of Michigan, PC
Orthopaedic Associates of Michigan, PC
Not Provided
Principal Investigator: John G Anderson, MD Orthopaedic Associates of Michigan, PC
Orthopaedic Associates of Michigan, PC
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP