A Comparison of Outcomes After Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) Surgery Using Semiconductor Fabric Products: A Randomized, Double-Blinded, Placebo-Controlled Prospective Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Range of motion
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 16 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control Group
This arm of the study involves the control group who will receive the standard of care.
Semiconducting Fabric Sleeve Group
This group will be receiving semiconducting fabric sleeve to be worn post-operatively.
Intervention: Semiconducting fabric sleeves (Device)
Placebo Group
This group receives a look-alike sleeve that contains no semiconductor material.
Intervention: Non-semiconducting fabric sleeves (Device)
Outcomes
Primary Outcomes
Range of motion
Time Frame: 1 year
Measured extension and flexion values using a goniometer at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year time points
Secondary Outcomes
- Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires(1 year)
- Effusion Measurements(1 year)
Investigators
Ronak M. Patel
Sports Medicine Orthopedic Surgeon
Illinois Center for Orthopaedic Research and Education