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Comparing Ankle Fusion to Ankle Replacement
Sponsor: Seattle Institute for Biomedical and Clinical Research
Summary
End-stage ankle arthritis (ESAA) is a debilitating condition associated with severe pain, dysfunction, and reduced quality of life. Many patients with ESAA have difficulty walking for even 100 feet or up a single flight of stairs. Patients seeking surgery for ESAA have two primary treatment options: ankle arthrodesis (i.e., ankle fusion) and ankle arthroplasty (i.e., ankle replacement). Few studies have directly compared the effectiveness of these two procedures, and no randomized controlled trials (RCTs) have been performed. The investigators will compare the following in subjects undergoing ankle arthrodesis and ankle arthroplasty before surgery, and post-surgery at 3 and 6 months, and on an annual basis up to ten years. 1. Overall physical function and ankle specific function 2. Ankle pain intensity and interference with activities 3. Activity levels 4. Overall general health 5. Post-surgical complication rates The investigators will also identify prognostic factors that are predictive of higher physical function, ankle specific function, reduced pain, improved general health, and overall patient satisfaction.
Official title: Comparing Ankle Arthrodesis to Ankle Arthroplasty
Key Details
Gender
All
Age Range
21 Years - 89 Years
Study Type
OBSERVATIONAL
Enrollment
516
Start Date
2012-05
Completion Date
2027-05
Last Updated
2025-04-08
Healthy Volunteers
No
Interventions
Ankle Arthrodesis
All surgeons will employ a well-established technique of rigid internal fixation. In this technique, the joint is prepared by removing cartilage from the surfaces, the bones are positioned as desired, and screws and/or a plate are attached to compress the bones together and prevent motion. This technique obviates the need for a cast or external support. Patients are allowed to walk with weight bearing aids immediately. Radiographs are performed at 6 weeks to determine weight bearing status. Weight is allowed on the limb in increments over the 6 to 12 weeks after surgery.
Ankle Arthroplasty
Protocols are similar among participating centers. Each surgeon uses an anterior surgical approach between the tibialis anterior tendon and the toe extensor group, splints the ankles for 2 weeks, and restricts weight bearing for the first 6 weeks. Radiographs are performed at 6 weeks to determine weight bearing status. The study involves only FDA approved implants with which the surgeon has established experience.
Locations (6)
Orthopaedic and Spine Center of the Rockies
Fort Collins, Colorado, United States
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, United States
Twin Cities Orthopedics
Edina, Minnesota, United States
Orthopedic + Fracture Specialists
Portland, Oregon, United States
Harborview Medical Center
Seattle, Washington, United States
VA Puget Sound Health Care System
Seattle, Washington, United States