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NCT01620541 · ClinicalTrials.gov registry record
Comparing Ankle Fusion to Ankle Replacement
A clinical trial of Osteoarthritis (OA) and End-stage Ankle Arthritis (ESAA), sponsored by Seattle Institute for Biomedical and Clinical Research.
- Active
- Registry status
- 516
- Enrollment target
- 6
- Study locations
NCT01620541: Active study of Osteoarthritis (OA) and End-stage Ankle Arthritis (ESAA), sponsored by Seattle Institute for Biomedical and Clinical Research.
NCT01620541 is a study of Osteoarthritis (OA) and End-stage Ankle Arthritis (ESAA) that is active but no longer recruiting, run by Seattle Institute for Biomedical and Clinical Research. The registered enrollment target is 516 participants. The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01620541, a study of Osteoarthritis (OA) and End-stage Ankle Arthritis (ESAA), is active but no longer recruiting, sponsored by Seattle Institute for Biomedical and Clinical Research.
- ACTIVE NOT RECRUITING
- Registry status
- 516 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
Ankle specific function was assessed using the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) subscale, a validated, self-reported questionnaire which measures functional ability during activities of daily living. \[CH1.1\]The FAAM ADL subscale sums and coverts responses to a standardized score ranging from 0 to 100%. A score of 0% represents complete disability, and a score of 100% represents no functional limitations. Higher scores indicate better ankle function.
Conditions Studied
Interventions
- PROCEDURE Ankle Arthrodesis
- PROCEDURE Ankle Arthroplasty
Study Locations (6)
Washington
- Harborview Medical Center - Seattle
- VA Puget Sound Health Care System - Seattle
Colorado
- Orthopaedic and Spine Center of the Rockies - Fort Collins
Michigan
- Orthopaedic Associates of Michigan - Grand Rapids
Minnesota
- Twin Cities Orthopedics - Edina
Oregon
- Orthopedic + Fracture Specialists - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 516 participants |
| Start Date | 2012-05 |
| Est. Completion | 2027-05 |
What the registry record for NCT01620541 still lists
NCT01620541 is an observational study that tracks outcomes without assigning an intervention. The registered 516 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with Osteoarthritis (OA) appearing as the primary indexed condition, and to 2 interventions - of which Ankle Arthrodesis is the first listed.
NCT01620541 lists 6 locations in 5 states (Washington, Colorado, Michigan).
Frequently Asked Questions
What is clinical trial NCT01620541 about?
NCT01620541 is a clinical study titled "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:...
What is the current status of trial NCT01620541?
This trial is currently active not recruiting. The enrollment target is 516 participants. The study started on 2012-05. Estimated completion is 2027-05.
What conditions does trial NCT01620541 study?
This clinical trial studies the following conditions: Osteoarthritis (OA), End-stage Ankle Arthritis (ESAA).
What interventions are being tested in trial NCT01620541?
The interventions under investigation include: Ankle Arthrodesis (PROCEDURE), Ankle Arthroplasty (PROCEDURE).
Who is sponsoring clinical trial NCT01620541?
This trial is sponsored by Seattle Institute for Biomedical and Clinical Research, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01620541 being conducted?
This trial has 6 study locations across Colorado, Michigan, Minnesota, Oregon, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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