Actively Recruiting
A Comparison of Outcomes After Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) Surgery Using Semiconductor Fabric Products
Led by Illinois Center for Orthopaedic Research and Education · Updated on 2025-05-22
135
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
Sponsors
I
Illinois Center for Orthopaedic Research and Education
Lead Sponsor
I
INCREDIWEAR HOLDINGS, INC.
Collaborating Sponsor
AI-Summary
What this Trial 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. 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
CONDITIONS
Official Title
A Comparison of Outcomes After Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) Surgery Using Semiconductor Fabric Products
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing ACL or ACL+Meniscus surgery
- Age 16 - 65
- Body Mass Index (BMI) less than 40
- Willing and able to follow study schedule and guidelines
- Able to sign consent or assent form
You will not qualify if you...
- History of neurological conditions like multiple sclerosis or Parkinson's disease
- Severe medical conditions such as recent heart attack, unstable angina, heart failure, or severe anemia
- Prior knee surgery within 5 years or knee injections within 6 months
- Chronic pain conditions unrelated to the knee
- Autoimmune or autoinflammatory diseases
- Poorly controlled diabetes (HgA1c over 7.5)
- Body Mass Index (BMI) over 39.9
- Varicose veins on the leg being operated on
- Severe peripheral artery disease (ABI less than 0.6)
- Receiving pain management treatment
- History of blood clots or stroke
- Tobacco use within the last 90 days
- Outside the age range of 16-65
- Active infection or open wound near the sleeve application area
- Unable or unwilling to sign consent or assent
- Any other condition that may prevent study completion or affect results according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Illinois Bone and Joint Institute
Westmont, Illinois, United States, 60559
Actively Recruiting
Research Team
R
Ronak M Patel, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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