Comparing Ankle Fusion to Ankle Replacement

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Comparing Ankle Arthrodesis to Ankle Arthroplasty

Conditions
-----------------
End-stage Ankle Arthritis (ESAA), Osteoarthritis (OA)

Intervention / Treatment
-----------------
* Procedure: Ankle Arthrodesis
* Procedure: Ankle Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preference, Ankle Arthrodesis<br> | Procedure: Ankle Arthrodesis<br>* 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.<br>* Other names: Ankle Fusion;|
| Preference, Ankle Arthroplasty<br> | Procedure: Ankle Arthroplasty<br>* 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.<br>* Other names: Total Ankle Replacement;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. |