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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AR056316-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
| National Institutes of Health (NIH) | NIH |
| University of Washington | OTHER |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preference, Ankle Arthrodesis |
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| Preference, Ankle Arthroplasty |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ankle Arthrodesis | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in overall physical function and ankle specific function between subjects undergoing ankle arthrodesis and total ankle arthroplasty | Questionnaire data (Foot and Ankle Ability Measure; SF-36 Health Survey) | Before surgery, and post-surgery at 3 and 6 months, and on an annual basis up to ten years. |
| Change in overall pain intensity and ankle specific pain intensity; Interference with activities in subjects undergoing ankle arthrodesis and total ankle arthroplasty | Questionnaire data (Foot and Ankle Ability Measure; Chronic Pain Grade) | Before surgery and post-surgery at 3 and 6 months, and on an annual basis up to ten years. |
| Change in general health in subjects undergoing ankle arthrodesis and total ankle arthroplasty | Questionnaire data (Functional Comorbidity Index and SF-36 Health Survey) | Before surgery and post-surgery at 3 and 6 months, and on an annual basis up to ten years. |
| Measure | Description | Time Frame |
|---|---|---|
| Intrinsic and extrinsic prognostic factors which are predictive of higher physical function, ankle specific function, reduced pain, improved general health, and overall patient satisfaction | Medical record review and questionnaire data | Assessed before surgery and post-surgery at 3 and 6 months, and on an annual basis up to ten years. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects are recruited from surgical foot and ankle orthopedic clinics at the participating study sites.
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| Name | Affiliation | Role |
|---|---|---|
| Bruce J Sangeorzan, MD | VA Puget Sound Health Care System & University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic and Spine Center of the Rockies | Fort Collins | Colorado | 80525 | United States | ||
| Orthopaedic Associates of Michigan |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 24, 2026 | |
| Reset | May 15, 2026 | |
| Release | May 28, 2026 | |
| Reset | Jun 23, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 24, 2026 | May 15, 2026 | |||
| May 28, 2026 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D058737 | Arthroplasty, Replacement, Ankle |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Orthopedic + Fracture Specialists, Portland, OR |
| OTHER |
| Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics | UNKNOWN |
| Orthopaedic and Spine Center of the Rockies | UNKNOWN |
| Orthopaedic Associates of Michigan, PC | OTHER |
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| Ankle Arthroplasty | Procedure | 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. |
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| Post-surgical complication rates |
Medical record review |
| Assessed monthly until 24 months after surgery |
| Change in daily step counts | Step counts using a StepWatch Activity Monitor, worn for a 7-14 day time period. | Before surgery and at 6, 12, and 24 months after surgery |
| Change in patient satisfaction | Questionnaire data | Done post-surgery at 3 and 6 months, and on an annual basis up to ten years. |
| Grand Rapids |
| Michigan |
| 49525 |
| United States |
| Twin Cities Orthopedics | Edina | Minnesota | 55435 | United States |
| Orthopedic + Fracture Specialists | Portland | Oregon | 97225 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| VA Puget Sound Health Care System | Seattle | Washington | 98108 | United States |
| Jun 23, 2026 |
| Jun 26, 2026 |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |