Comparing Ankle Fusion to Ankle Replacement

Active, not recruiting

• Conditions: End-stage Ankle Arthritis (ESAA); Osteoarthritis (OA)
• Interventions: Procedure: Ankle Arthrodesis; Procedure: Ankle Arthroplasty

• Registration Number: NCT01620541
• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research

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.

1. Overall physical function and ankle specific function

2. Ankle pain intensity and interference with activities

3. Activity levels

4. Overall general health

5. 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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04
• Primary Completion: 2026-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 516

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

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preference, Ankle Arthrodesis	Ankle Arthrodesis	-
Preference, Ankle Arthroplasty	Ankle Arthroplasty	-

Primary Outcome Measures

Name	Time	Method
Change in overall pain intensity and ankle specific pain intensity; Interference with activities in subjects undergoing ankle arthrodesis and total ankle arthroplasty	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 overall physical function and ankle specific function between subjects undergoing ankle arthrodesis and total ankle arthroplasty	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 general health in subjects undergoing ankle arthrodesis and total ankle arthroplasty	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)

Secondary Outcome Measures

Name	Time	Method
Change in daily step counts	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.
Intrinsic and extrinsic prognostic factors which are predictive of higher physical function, ankle specific function, reduced pain, improved general health, and overall patient satisfaction	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	Assessed monthly until 24 months after surgery	Medical record review
Change in patient satisfaction	Done post-surgery at 3 and 6 months, and on an annual basis up to ten years.	Questionnaire data

Trial Locations

Locations (6)

Orthopedic + Fracture Specialists; 🇺🇸 Portland, Oregon, United States

Orthopaedic Associates of Michigan; 🇺🇸 Grand Rapids, Michigan, United States

Twin Cities Orthopedics; 🇺🇸 Edina, Minnesota, United States

Orthopaedic and Spine Center of the Rockies; 🇺🇸 Fort Collins, Colorado, United States

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

VA Puget Sound Health Care System; 🇺🇸 Seattle, Washington, United States