Comparing Ankle Fusion to Ankle Replacement

Osteoarthritis (OA) Clinical Trial

Official title:

Comparing Ankle Arthrodesis to Ankle Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01620541
• Other study ID #: SB223
• Secondary ID: 1R01AR056316-01A
• Status: Active, not recruiting
• Start date: May 2012
• Est. completion date: May 2027

Study information

• Verified date: April 2024
• Source: Seattle Institute for Biomedical and Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 516
• Est. completion date: May 2027
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 89 Years

Eligibility

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

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

Related Conditions & MeSH terms

• End-stage Ankle Arthritis (ESAA)
• Osteoarthritis
• Osteoarthritis (OA)

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Twin Cities Orthopedics	Edina	Minnesota
United States	Orthopaedic and Spine Center of the Rockies	Fort Collins	Colorado
United States	Orthopaedic Associates of Michigan	Grand Rapids	Michigan
United States	Orthopedic + Fracture Specialists	Portland	Oregon
United States	Harborview Medical Center	Seattle	Washington
United States	VA Puget Sound Health Care System	Seattle	Washington

Sponsors (8)

Lead Sponsor	Collaborator
Seattle Institute for Biomedical and Clinical Research	Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Orthopaedic and Spine Center of the Rockies, Orthopaedic Associates of Michigan, PC, Orthopedic + Fracture Specialists, Portland, OR, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	Post-surgical complication rates	Medical record review	Assessed monthly until 24 months after surgery
Secondary	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
Secondary	Change in patient satisfaction	Questionnaire data	Done post-surgery at 3 and 6 months, and on an annual basis up to ten years.