End-stage Ankle Arthritis (ESAA)NCT01620541
Comparing Ankle Fusion to Ankle Replacement
An observational study of End-stage Ankle Arthritis (ESAA) and Osteoarthritis (OA), run by Seattle Institute for Biomedical and Clinical Research at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- End-stage Ankle Arthritis (ESAA), Osteoarthritis (OA)
- What is being tested?
- Ankle Arthrodesis and Ankle Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 517 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2012to Apr 2026
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects are recruited from surgical foot and ankle orthopedic clinics at the participating study sites.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Twin Cities Orthopedics
Edina, Minnesota, 55435
Orthopaedic and Spine Center of the Rockies
Fort Collins, Colorado, 80525
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, 49525
Orthopedic + Fracture Specialists
Portland, Oregon, 97225
Harborview Medical Center
Seattle, Washington, 98104
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
Official title: Comparing Ankle Arthrodesis to Ankle Arthroplasty
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.
Read more
- Overall physical function and ankle specific function
- Ankle pain intensity and interference with activities
- Activity levels
- Overall general health
- 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.
Read the detailed description
From study inception until March 2014, the investigators conducted a multi-site randomized controlled trial (RCT) comparing the effectiveness of ankle arthrodesis and ankle arthroplasty over a 2-year follow-up period. The study used a modified Comprehensive Cohort Design. Subjects unwilling to randomize to surgery could still participate in the study by entering into the preference cohort and select surgery in consultation with their surgeon.
By March 2014, no subjects had entered into the randomized cohort. The Data and Safety Monitoring Board (DSMB) recommended stopping recruitment in the randomized arm of the study since no subjects were willing to randomize to surgery. All patients were enrolled in the preference cohort and selected arthrodesis or arthroplasty. Despite the change in study design, the objectives remain unchanged.
- Being tested
- Ankle Arthrodesis, Ankle Arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle ArthrodesisProcedure or surgery
Also called Ankle Fusion
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 ArthroplastyProcedure or surgery
Also called Total Ankle Replacement
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.
| Study group | Role | What they receive |
|---|---|---|
| Preference, Ankle Arthrodesis | Not described Receives: Procedure: Ankle Arthrodesis | |
| Preference, Ankle Arthroplasty | Not described Receives: Procedure: Ankle Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Score Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
Ankle specific function was assessed using the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) subscale, a validated, self-reported questionnaire which measures functional ability during activities of daily living. [CH1.1]The FAAM ADL subscale sums and coverts responses to a standardized score ranging from 0 to 100%. A score of 0% represents complete disability, and a score of 100% represents no functional limitations. Higher scores indicate better ankle function.
Measured: Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-op
Change in Foot and Ankle Ability Measure (FAAM) Sports Subscale Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
Ankle specific function during sports activities was measured using the Foot and Ankle Ability Measure (FAAM) Sports subscale, a validated, self-reported questionnaire which measures functional ability during sport-related activities. The FAAM Sports subscale sums and converts responses to a standardized score ranging from 0 to 100%. A score of 0% represents complete disability, and a score of 100% represents no functional limitations. Higher scores indicate better ankle function during sports activities.
Measured: Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-op
Change in Short Form-36 (SF-36) Physical Component Summary (PCS) Score Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
Ankle specific function was assessed using the Short Form-36 (SF-36) Physical Component Summary (PCS) score, a validated, generic measure of health-related quality of life that evaluates physical health status. The PCS score is derived from responses to the SF-36 questionnaire and is norm-based, with scores ranging from 0-100, where higher scores indicate better physical health and lower scores indicate poorer physical health.
Measured: Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-op
Change in Overall Pain Intensity and Ankle Specific Pain Intensity; Interference With Activities in Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty (Worst Pain)
Pain was assessed using two questions from the Chronic Pain Grade (CPG), including intensity of worst pain in past 6 months. This was scored on a 0-10 point scale where higher scores represented greater pain (e.g., 0 = "no pain" and 10 = "pain as bad as it could be")
Measured: Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-op
Change in Overall Pain Intensity and Ankle Specific Pain Intensity; Interference With Activities in Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty (Average Pain)
Pain was assessed using two questions from the Chronic Pain Grade (CPG), including intensity of average ankle pain in past 6 months. This was scored on a 0-10 point scale where higher scores represented greater pain (e.g., 0 = "no pain" and 10 = "pain as bad as it could be")
Measured: Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-op
Secondary outcomes (2)
Post-surgical Complication Rates
Ankle-specific complications in the 12-month period post surgery
Measured: Assessed monthly until 12 months after surgery
Change in Daily Step Counts
Step counts using a StepWatch Activity Monitor, worn for a 7-14 day time period.
Measured: Before surgery and at 6, 12, and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2026
- Study completionApr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End-stage Ankle Arthritis (ESAA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 517 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), University of Washington, Orthopedic + Fracture Specialists, Portland, OR, Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics, Orthopaedic and Spine Center of the Rockies, Orthopaedic Associates of Michigan, PC
- Responsible party
- Sponsor
- Investigators
- Bruce J Sangeorzan, MD, Principal investigator, VA Puget Sound Health Care System & University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620541
- Sponsor's protocol ID
- SB223
- Other IDs
- 1R01AR056316-01A2
- Status last verified
- Aug 2026
- First submitted
- 11 Jun 2012
- Last updated
- 21 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Ankle Arthrodesis to Ankle Arthroplasty
- ClinicalTrials.gov ID
- NCT01620541
- Acronym / sponsor ID
- SB223
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), University of Washington, Orthopedic + Fracture Specialists, Portland, OR, Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics, Orthopaedic and Spine Center of the Rockies, Orthopaedic Associates of Michigan, PC
- Study start
- May 2012 (actual)
- Primary completion
- Apr 2026 (actual)
- Study completion
- Apr 2026 (actual)
- First posted
- 15 Jun 2012 (estimated)
- Results
- Posted 21 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Overall physical function and ankle specific function
- Ankle pain intensity and interference with activities
- Activity levels
- Overall general health
- 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.
Detailed description
From study inception until March 2014, the investigators conducted a multi-site randomized controlled trial (RCT) comparing the effectiveness of ankle arthrodesis and ankle arthroplasty over a 2-year follow-up period. The study used a modified Comprehensive Cohort Design. Subjects unwilling to randomize to surgery could still participate in the study by entering into the preference cohort and select surgery in consultation with their surgeon.
By March 2014, no subjects had entered into the randomized cohort. The Data and Safety Monitoring Board (DSMB) recommended stopping recruitment in the randomized arm of the study since no subjects were willing to randomize to surgery. All patients were enrolled in the preference cohort and selected arthrodesis or arthroplasty. Despite the change in study design, the objectives remain unchanged.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preference, Ankle Arthrodesis | – | Procedure: Ankle Arthrodesis |
| Preference, Ankle Arthroplasty | – | Procedure: Ankle Arthroplasty |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are recruited from surgical foot and ankle orthopedic clinics at the participating study sites.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle ArthrodesisAlso: Ankle FusionAll 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. | Procedure or surgery | Preference, Ankle Arthrodesis |
| Ankle ArthroplastyAlso: Total Ankle ReplacementProtocols 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. | Procedure or surgery | Preference, Ankle Arthroplasty |
Primary outcome
Change in Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Score Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
Time frame: Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-op
Ankle specific function was assessed using the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) subscale, a validated, self-reported questionnaire which measures functional ability during activities of daily living. [CH1.1]The FAAM ADL subscale sums and coverts responses to a standardized score ranging from 0 to 100%. A score of 0% represents complete disability, and a score of 100% represents no functional limitations. Higher scores indicate better ankle function.
Change in Foot and Ankle Ability Measure (FAAM) Sports Subscale Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
Time frame: Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-op
Ankle specific function during sports activities was measured using the Foot and Ankle Ability Measure (FAAM) Sports subscale, a validated, self-reported questionnaire which measures functional ability during sport-related activities. The FAAM Sports subscale sums and converts responses to a standardized score ranging from 0 to 100%. A score of 0% represents complete disability, and a score of 100% represents no functional limitations. Higher scores indicate better ankle function during sports activities.
Change in Short Form-36 (SF-36) Physical Component Summary (PCS) Score Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
Time frame: Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-op
Ankle specific function was assessed using the Short Form-36 (SF-36) Physical Component Summary (PCS) score, a validated, generic measure of health-related quality of life that evaluates physical health status. The PCS score is derived from responses to the SF-36 questionnaire and is norm-based, with scores ranging from 0-100, where higher scores indicate better physical health and lower scores indicate poorer physical health.
Change in Overall Pain Intensity and Ankle Specific Pain Intensity; Interference With Activities in Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty (Worst Pain)
Time frame: Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-op
Pain was assessed using two questions from the Chronic Pain Grade (CPG), including intensity of worst pain in past 6 months. This was scored on a 0-10 point scale where higher scores represented greater pain (e.g., 0 = "no pain" and 10 = "pain as bad as it could be")
Change in Overall Pain Intensity and Ankle Specific Pain Intensity; Interference With Activities in Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty (Average Pain)
Time frame: Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-op
Pain was assessed using two questions from the Chronic Pain Grade (CPG), including intensity of average ankle pain in past 6 months. This was scored on a 0-10 point scale where higher scores represented greater pain (e.g., 0 = "no pain" and 10 = "pain as bad as it could be")
2 secondary outcomes
Post-surgical Complication Rates
Time frame: Assessed monthly until 12 months after surgery
Change in Daily Step Counts
Time frame: Before surgery and at 6, 12, and 24 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce J Sangeorzan, MD principal investigator
VA Puget Sound Health Care System & University of Washington
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Ankle Arthritis (ESAA) and Osteoarthritis (OA), run by Seattle Institute for Biomedical and Clinical Research at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Score Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty (time frame: Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-op). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.