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Surgical Approaches for Ankle Replacement in Osteoarthritis
Study Summary
This trial is testing two approaches to ankle replacement surgery to see which is safer and more effective.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- Your doctor cannot feel your pulse in your front or back foot, or you have problems with blood flow in your capillaries.You have a medical condition that makes it unsafe for you to receive the proposed treatments.You have been experiencing symptoms related to your condition for at least six months before the surgery.You have been diagnosed with arthritis in your ankle based on physical exams and imaging tests.You are planning to have surgery to replace your entire ankle joint.You have an infection in the area that needs treatment, either on the skin or deep in the bones.You have been diagnosed with untreated osteoporosis based on medical exams and imaging tests.You have a history of autoimmune or peripheral vascular diseases.You have a history of nerve problems or inflammatory diseases like arthritis.
- Group 1: Lateral Approach
- Group 2: Anterior Approach
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the research program open to new participants?
"Affirmative. Clinicaltrials.gov hosts information that confirms this experiment is actively recruiting participants, having been first posted on July 5th 2022 and last updated on September 29th 2022. The trial aims to recruit 50 patients from a single clinical centre."
Is this research opportunity available to those below the age of fifty?
"This trial is available to those over 18 and under 90. There are 30 studies specifically for minors and 583 trials dedicated to seniors."
To whom does this research opportunity extend?
"The current clinical trial is in search of 50 participants aged between 18 and 90 with complaints of ankle arthritis. Ultimately, to be eligible for the study, applicants should have experienced symptoms related to their condition for a minimum period of six months prior to the surgery, display established signs on X-ray imaging and meet both the upper and lower age limits."
What is the ultimate objective of this experiment?
"This medical study, intended to last 6 months post-surgery, aims to assess potential complications. Secondary goals include Foot and Ankle Ability Measure (to compare patient reported outcomes between the two groups), PROMIS Physical Function 8B (to compare patient reported outcomes between the two group), and PROMIS Global Health (to compare patient reported outcomes between the two groups)."
What is the cap on enrollment for this clinical investigation?
"Affirmative. The clinical trial's listing on clinicaltrials.gov reveals that recruitment began on July 5th 2022 and has most recently been updated on September 29th 2022. This study is currently seeking to enrol 50 patients from a single medical site."
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