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Comparing Ankle Fusion to Ankle Replacement
NCT01620541 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01620541
The ClinicalTrials.gov registry entry for NCT01620541 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 516 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Institute for Biomedical and Clinical Research, which has 17 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01620541 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Washington, Colorado, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01620541?
The interventions under investigation include: Ankle Arthrodesis (PROCEDURE), Ankle Arthroplasty (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01620541?
This trial is sponsored by Seattle Institute for Biomedical and Clinical Research, which has 17 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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