NCT06979804 · Illinois Center for Orthopaedic Research and Education
A Comparison of Outcomes After Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) Surgery Using Semiconductor Fabric Products
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
- Patient is considered a pain management patient
- Patient has had previous blood clots or stroke
- Patient has used tobacco within the last 90 days
- Patient is not within the ages of 16-65
- Patient has an active infection (local or systemic), or an open (non-surgical) wound in the areas of product application
- Patient is unwilling or unable to sign the corresponding research subject consent/assent form
- Patient meets any other criteria or has any other condition that, in the opinion of the investigator, would prevent them from completing the study or that, in the opinion of the investigator, would confound study results.
Where
- Westmont, Illinois
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2025 · Source of record for eligibility and locations