Which surgery wins for ankle arthritis? a Head-to-Head trial

NCT ID NCT01620541

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

517 people

The number who actually took part.

Started

May 2012

Finished

Apr 2026

Lead sponsor

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

21 to 89 years

Sex

Anyone

Healthy volunteers

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

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

  • Harborview Medical Center

    Seattle, Washington, 98104, United States

  • Orthopaedic Associates of Michigan

    Grand Rapids, Michigan, 49525, United States

  • Orthopaedic and Spine Center of the Rockies

    Fort Collins, Colorado, 80525, United States

  • Orthopedic + Fracture Specialists

    Portland, Oregon, 97225, United States

  • Twin Cities Orthopedics

    Edina, Minnesota, 55435, United States

  • VA Puget Sound Health Care System

    Seattle, Washington, 98108, United States

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