Which surgery wins for ankle arthritis? a Head-to-Head trial
NCT ID NCT01620541
First seen Aug 21, 2026 ยท Last updated Aug 21, 2026
Summary
This trial compares two common surgeries for end-stage ankle arthritis: ankle fusion (arthrodesis) and ankle replacement (arthroplasty). It aims to see which procedure better improves daily function, reduces pain, and enhances quality of life. Adults with ankle arthritis who are surgical candidates will be randomly assigned to one of the two procedures and followed for up to ten years. The study also tracks complications and activity levels to help guide treatment decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Two surgical procedures: ankle arthrodesis (fusion) and ankle arthroplasty (replacement)
- What this could lead to
- If this trial succeeds, it could help doctors and patients choose the better surgical option for end-stage ankle arthritis, improving pain relief and mobility.
- What could go wrong
- This is a randomized trial, but results may not apply to all patients. Both surgeries carry risks like infection, nerve damage, or the need for further surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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517 people
The number who actually took part.
- Started
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May 2012
- Finished
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Apr 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Subjects are recruited from surgical foot and ankle orthopedic clinics at the participating study sites.
- Ages
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21 to 89 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Diagnosis of ankle arthritis 2. Failed conservative care and deemed a surgical candidate 3. Adult patients between 21 and 89 years of age 4. Ambulatory but whose primary impediment to pain-free ambulation is ankle arthritis Exclusion Criteria: 1. 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 2. Complicated procedures requiring multiple corrections 3. Inflammatory arthritis with multi-focal disease (i.e. arthritis that affects multiple parts of the body) 4. Inadequate cognitive or language function to consent to participate 5. Unable or unwilling to participate in clinic follow-ups and/or remote follow-ups for 24 months after surgery 6. Unwilling or unable to comply with postoperative management program 7. Lack of a telephone number or stable mailing address
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Harborview Medical Center
Seattle, Washington, 98104, United States
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Orthopaedic Associates of Michigan
Grand Rapids, Michigan, 49525, United States
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Orthopaedic and Spine Center of the Rockies
Fort Collins, Colorado, 80525, United States
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Orthopedic + Fracture Specialists
Portland, Oregon, 97225, United States
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Twin Cities Orthopedics
Edina, Minnesota, 55435, United States
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VA Puget Sound Health Care System
Seattle, Washington, 98108, United States
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