Comparing Ankle Fusion to Ankle Replacement

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.

Conditions

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

Interventions

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.

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.

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• University of Washington

  collaborator OTHER

• Orthopedic + Fracture Specialists, Portland, OR

  collaborator OTHER

• Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics

  collaborator UNKNOWN

• Orthopaedic and Spine Center of the Rockies

  collaborator UNKNOWN

• Orthopaedic Associates of Michigan, PC

  collaborator OTHER

• Seattle Institute for Biomedical and Clinical Research

  lead OTHER

Principal Investigators

• Bruce J Sangeorzan, MD · VA Puget Sound Health Care System & University of Washington

Eligibility

Min Age

21 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2026-05-31

Completion

2027-05-31

Countries

• United States

Study Locations