Comparing Ankle Fusion to Ankle Replacement

Running, not enrolling

Conditions studied: End-stage Ankle Arthritis (ESAA), Osteoarthritis (OA)

In brief

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.

Key facts

Study ID

NCT01620541

Run by

Seattle Institute for Biomedical and Clinical Research

People needed

516

Starts

2012-05-01

Expected to finish

2027-05-01

Last updated by the study team

2025-04-08

Who can join

Age: 21 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of ankle arthritis
• Failed conservative care and deemed a surgical candidate
• Adult patients between 21 and 89 years of age
• Ambulatory but whose primary impediment to pain-free ambulation is ankle arthritis

You may not qualify if…

• Recent surgical, neurological, metabolic, or lower limb musculoskeletal problem that might impair the ambulation measures in the study such as severe knee or hip osteoarthritis
• Complicated procedures requiring multiple corrections
• Inflammatory arthritis with multi-focal disease (i.e. arthritis that affects multiple parts of the body)
• Inadequate cognitive or language function to consent to participate
• Unable or unwilling to participate in clinic follow-ups and/or remote follow-ups for 24 months after surgery
• Unwilling or unable to comply with postoperative management program
• Lack of a telephone number or stable mailing address

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.