Comparing Ankle Fusion to Ankle Replacement
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|ClinicalTrials.gov Identifier: NCT01620541|
Recruitment Status : Active, not recruiting
First Posted : June 15, 2012
Last Update Posted : October 7, 2019
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.
|Condition or disease||Intervention/treatment|
|End-stage Ankle Arthritis (ESAA) Osteoarthritis (OA)||Procedure: Ankle Arthrodesis Procedure: Ankle Arthroplasty|
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 Type :||Observational|
|Actual Enrollment :||516 participants|
|Official Title:||Comparing Ankle Arthrodesis to Ankle Arthroplasty|
|Actual Study Start Date :||May 2012|
|Estimated Primary Completion Date :||May 2026|
|Estimated Study Completion Date :||May 2027|
|Preference, Ankle Arthrodesis||
Procedure: Ankle Arthrodesis
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.
Other Name: Ankle Fusion
|Preference, Ankle Arthroplasty||
Procedure: Ankle Arthroplasty
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.
Other Name: Total Ankle Replacement
- Change in overall physical function and ankle specific function between subjects undergoing ankle arthrodesis and total ankle arthroplasty [ Time Frame: Before surgery, and post-surgery at 3 and 6 months, and on an annual basis up to ten years. ]Questionnaire data (Foot and Ankle Ability Measure; SF-36 Health Survey)
- Change in overall pain intensity and ankle specific pain intensity; Interference with activities in subjects undergoing ankle arthrodesis and total ankle arthroplasty [ Time Frame: Before surgery and post-surgery at 3 and 6 months, and on an annual basis up to ten years. ]Questionnaire data (Foot and Ankle Ability Measure; Chronic Pain Grade)
- Change in general health in subjects undergoing ankle arthrodesis and total ankle arthroplasty [ Time Frame: Before surgery and post-surgery at 3 and 6 months, and on an annual basis up to ten years. ]Questionnaire data (Functional Comorbidity Index and SF-36 Health Survey)
- Intrinsic and extrinsic prognostic factors which are predictive of higher physical function, ankle specific function, reduced pain, improved general health, and overall patient satisfaction [ Time Frame: Assessed before surgery and post-surgery at 3 and 6 months, and on an annual basis up to ten years. ]Medical record review and questionnaire data
- Post-surgical complication rates [ Time Frame: Assessed monthly until 24 months after surgery ]Medical record review
- Change in daily step counts [ Time Frame: Before surgery and at 6, 12, and 24 months after surgery ]Step counts using a StepWatch Activity Monitor, worn for a 7-14 day time period.
- Change in patient satisfaction [ Time Frame: Done post-surgery at 3 and 6 months, and on an annual basis up to ten years. ]Questionnaire data
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620541
|United States, Colorado|
|Orthopaedic and Spine Center of the Rockies|
|Fort Collins, Colorado, United States, 80525|
|United States, Michigan|
|Orthopaedic Associates of Michigan|
|Grand Rapids, Michigan, United States, 49525|
|United States, Minnesota|
|Twin Cities Orthopedics|
|Edina, Minnesota, United States, 55435|
|United States, Oregon|
|Orthopedic + Fracture Specialists|
|Portland, Oregon, United States, 97225|
|United States, Washington|
|Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|VA Puget Sound Health Care System|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||Bruce J Sangeorzan, MD||VA Puget Sound Health Care System & University of Washington|