Center for Limb Loss and MoBility
Comparing Ankle Arthrodesis to Ankle Arthroplasty
PI: Bruce Sangeorzan, M.D.
Investigator: William R. Ledoux, Ph.D.
Co Investigators: John Anderson MD, Donald Bohay MD, Michael Brage MD, Chris Coetzee MD, James Davitt MD, Michael Houghton MD
Agency: National Institutes of Health (NIH)
Dates: September 2011 – August 2016
Introduction: End-stage ankle arthritis (ESAA) is a debilitating condition associated with severe pain, limited mobility, and reduced quality of life. Patients seeking surgery for ESAA have two primary treatment options: ankle arthrodesis (or "ankle fusion") and ankle arthroplasty (or "ankle replacement"). Each surgery has benefits and drawbacks, but few studies have directly compared the outcomes of these surgeries. It is also unknown whether certain patient characteristics are associated with more successful outcomes.
Objectives: The purpose of this study is to conduct a Randomized Controlled Trial (RCT) with a back door for patient-preference enrollment comparing ankle arthroplasty to ankle arthrodesis for treatment of ESAA. We will compare subjects’ pain, mobility, and general health before and after each surgery. We will also determine whether certain patient characteristics are associated with more successful outcomes.
Methodology: This is a multi-site study. The six participating sites are the VA Center of Excellence for Limb Loss Prevention and Prosthetic Engineering in Seattle; Harborview Medical Center/UW Medicine in Seattle; the Orthopedic and Fracture Clinic of Portland; Twin Cities Orthopedics of Minnesota; Orthopaedic Associates of Michigan; and the Orthopedic and Spine Center of the Rockies. Subjects will be randomly assigned to undergo either ankle arthrodesis or ankle arthroplasty, provided they are willing to be randomized. If subjects are not willing to be randomized, they can have the surgery of their choice and they will have the same testing. This is called a Comprehensive Cohort design.
Before surgery, we will ask all subjects to complete questionnaires measuring pain, mobility, and general health. Subjects will fill out the same questionnaires at 3, 6, 12, and 24 months after surgery, and they will also complete a short questionnaire that assesses their overall satisfaction with surgery. In addition, subjects will wear a StepWatch activity monitor (SAM) for two weeks before surgery, and for two weeks each at 6, 12 and 24 months after surgery. The SAM measures the number of steps that subjects take each day. The data from the questionnaires and the SAM will provide information about subjects’ pain, health, mobility, and activity levels before and after surgery. These data will allow us to determine whether one surgery works better than the other, and whether certain patient characteristics are associated with more successful outcomes.
Clinical Significance: Our study will provide the first randomized comparison of ankle arthroplasty and ankle arthrodesis. The results may help doctors determine which surgery is best for each patient. Currently, the choice between arthroplasty and arthrodesis is largely determined by surgeon training, and surgeon and patient preference. In 2010, the American Academy of Orthopaedic Surgeons (AAOS) had to abandon plans to publish clinical guidelines for treatment of ankle arthritis due to a lack of evidence. The data we obtain regarding pain, mobility, and general health will provide the foundation for an evidence-based approach to decision-making for the surgical treatment of ESAA.
Milestones: We obtained NIH funding for this project in September 2011, and we received VA IRB approval in September 2011. We expect to begin recruiting subjects by early 2012.