About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Semiconducting fabric sleeves
- Non-semiconducting fabric sleeves
Treatment groups
Sponsors and collaborators
Illinois Center for Orthopaedic Research and Education
Lead sponsor
INCREDIWEAR HOLDINGS, INC.
Collaborator