Overview

This trial is active, not recruiting.

Conditions end-stage ankle arthritis (esaa), osteoarthritis (oa)
Treatments ankle arthrodesis, ankle arthroplasty
Sponsor Seattle Institute for Biomedical and Clinical Research
Collaborator National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Start date May 2012
End date July 2022
Trial size 516 participants
Trial identifier NCT01620541, 1R01AR056316-01A2, SB223

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
ankle arthrodesis Ankle Fusion
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 Total Ankle Replacement
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.

Primary Outcomes

Measure
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.
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.
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.

Secondary Outcomes

Measure
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.
Post-surgical complication rates
time frame: Assessed monthly until 24 months after surgery
Change in daily step counts
time frame: Before surgery and at 6, 12, and 24 months after surgery
Change in patient satisfaction
time frame: Done post-surgery at 3 and 6 months, and on an annual basis up to ten years.

Eligibility Criteria

Male or female participants from 21 years up to 89 years old.

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

Additional Information

Official title Comparing Ankle Arthrodesis to Ankle Arthroplasty
Principal investigator Bruce J Sangeorzan, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Seattle Institute for Biomedical and Clinical Research.