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
  Purpose

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.


Condition
Rheumatoid Arthritis of Ankle
Osteoarthritis of Ankle
Traumatic Arthritis of Ankle

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Agility LP Ankle Arthroplasty: Clinical and Radiographic Outcomes

Resource links provided by NLM:


Further study details as provided by Orthopaedic Associates of Michigan, PC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: December 2010
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366872

Locations
United States, Michigan
Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, United States, 49525
Sponsors and Collaborators
Orthopaedic Associates of Michigan, PC
Investigators
Principal Investigator: John G Anderson, MD Orthopaedic Associates of Michigan, PC
  More Information

No publications provided

Responsible Party: John G. Anderson, MD, Principal Investigator, Orthopaedic Associates of Michigan, PC
ClinicalTrials.gov Identifier: NCT01366872     History of Changes
Other Study ID Numbers: OAM-LP-2010
Study First Received: June 2, 2011
Results First Received: October 16, 2012
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Orthopaedic Associates of Michigan, PC:
ankle
arthritis
total ankle arthroplasty
Agility LP,

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014