Comparing Ankle Fusion to Ankle Replacement

NCT01620541 | Active Not Recruiting DMC

• 2 other identifiers: SB2231R01AR056316-01A2
• Study Type: observational
• Target: 516
• Locations: 1 country
• Sites: 6

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. 1.Overall physical function and ankle specific function
2. 2.Ankle pain intensity and interference with activities
3. 3.Activity levels
4. 4.Overall general health
5. 5.Post-surgical complication rates

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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.

• Post-surgical complication rates

  Assessed monthly until 24 months after surgery

• Change in daily step counts

  Before surgery and at 6, 12, and 24 months after surgery

• Change in patient satisfaction

  Done post-surgery at 3 and 6 months, and on an annual basis up to ten years.

Study Arms (2)

Preference, Ankle Arthrodesis

Procedure: Ankle Arthrodesis

Preference, Ankle Arthroplasty

Procedure: Ankle Arthroplasty

Interventions

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.

Also known as: Ankle Fusion

Preference, Ankle Arthrodesis

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.

Also known as: Total Ankle Replacement

Preference, Ankle Arthroplasty

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects are recruited from surgical foot and ankle orthopedic clinics at the participating study sites.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (6)

Orthopaedic and Spine Center of the Rockies

Fort Collins, Colorado, 80525, United States

Location

Orthopaedic Associates of Michigan

Grand Rapids, Michigan, 49525, United States

Location

Twin Cities Orthopedics

Edina, Minnesota, 55435, United States

Location

Orthopedic + Fracture Specialists

Portland, Oregon, 97225, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Ankle

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Bruce J Sangeorzan, MD

  VA Puget Sound Health Care System & University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 15, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 8, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)