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
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.
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
Parallel
Semiconducting fabric sleeves
DeviceThis intervention includes semiconductor embedded sleeves that patients will wear for 4 months post-operatively.
Non-semiconducting fabric sleeves
DeviceThis intervention includes sleeves absent of semiconductors that will be worn for 4 months post-operatively.
Range of motion
Measured extension and flexion values using a goniometer at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year time points
Effusion Measurements
Effusion is measured by taking the circumference using a soft measuring tape at the following points: 1. Mid thigh: distance from palpation of Anterior Superior Iliac Spine (ASIS) to superior pole of patella, divided in half. (cm) 2. Knee: midpoint of the patella. (cm) 3. Mid calf: distance from top of fibular head to bottom of lateral malleolus, divided in half. (cm)
Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires
Visual Analog Scale (VAS) - assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.
Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires
International Knee Documentation Committee (IKDC) - assesses symptoms and function in daily living activities
Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires
Knee Single Assessment Numeric Evaluation (SANE) - assess knee function on a scale of 0 to 100, with 100 representing normal function
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Illinois Center for Orthopaedic Research and Education
Lead sponsor
INCREDIWEAR HOLDINGS, INC.
Collaborator
