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Recruiting NCT06979804

A Comparison of Outcomes After Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) Surgery Using Semiconductor Fabric Products

Trial Parameters

Condition ACL Reconstruction
Sponsor Illinois Center for Orthopaedic Research and Education
Study Type INTERVENTIONAL
Phase N/A
Enrollment 135
Sex ALL
Min Age 16 Years
Max Age 65 Years
Start Date 2024-09-11
Completion 2026-05-01
Interventions
Semiconducting fabric sleevesNon-semiconducting fabric sleeves

Brief Summary

The goal of this clinical trial is to determine the effect of semiconductor sleeves on the treatment of Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) arthroscopic surgery. The effect of the sleeves will be analyzed through patient reported and clinically measured outcomes. The main questions it aims to answer are: * Do the semiconductor sleeves improve the functional outcomes compared to the placebo? * Will patients experience improved functional outcomes in a shorter period of time compared to the placebo? Researchers will compare semiconductor fabric sleeves to a placebo (a look-alike sleeve that contains no semiconductor material) to see if the semiconductor fabric better treats ACL and ACL+meniscus surgical patients. Participants will: * Wear semiconductor or placebo leg sleeve for 4 weeks and knee sleeve for the following 12 weeks * Complete patient reported outcome surveys

Eligibility Criteria

Inclusion Criteria: * Patients undergoing ACL or ACL+Meniscus surgery * Age 16 - 65 * Patients with Body Mass Index (BMI) \<40 * Patients who are willing and able to adhere to follow-up schedule and protocol guidelines. * Patients who are willing and able to sign corresponding research subject consent/assent form. Exclusion Criteria: * Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease * Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia * Patient has had prior surgical treatment of the knee in the last 5 years or injection treatment(s) in the last 6 months * Patient has chronic pain conditions unrelated to knee condition * Patient has auto-immune or auto-inflammatory diseases * Patient has poorly controlled diabetes (HgA1c \> 7.5) * Patient has BMI \> 39.9 * Patient has varicosities on the operative leg * Patient has severe peripheral artery disease (ABI \< 0.6)

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