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Active, Not Recruiting

NCT Number: NCT01620541

Comparing Ankle Fusion to Ankle Replacement

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

End-stage Ankle Arthritis (ESAA) Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis (OA) Rheumatic Diseases

Age range

21 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Ankle Fusion

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.

Other names: Total Ankle Replacement

Primary outcomes

  1. Change in overall physical function and ankle specific function between subjects undergoing ankle arthrodesis and total ankle arthroplasty

    Time frame: 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)

  2. Change in overall pain intensity and ankle specific pain intensity; Interference with activities in subjects undergoing ankle arthrodesis and total ankle arthroplasty

    Time frame: 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)

  3. Change in general health in subjects undergoing ankle arthrodesis and total ankle arthroplasty

    Time frame: 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 outcomes

  1. Intrinsic and extrinsic prognostic factors which are predictive of higher physical function, ankle specific function, reduced pain, improved general health, and overall patient satisfaction

    Time frame: 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

  2. Post-surgical complication rates

    Time frame: Assessed monthly until 24 months after surgery

    Medical record review

  3. Change in daily step counts

    Time frame: 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.

  4. Change in patient satisfaction

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

    Questionnaire data

Sponsors and collaborators

Lead sponsor

Seattle Institute for Biomedical and Clinical Research

Other

Collaborators

  • 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 Associates of Michigan, PC
  • Orthopaedic and Spine Center of the Rockies
  • Orthopedic + Fracture Specialists, Portland, OR
  • University of Washington

Registry information

Official study title

Comparing Ankle Arthrodesis to Ankle Arthroplasty

Important dates

Study start
2012
Primary completion
2026
Study completion
2027
First posted
Jun 15, 2012
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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