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NCT Number: NCT06979804

A Comparison of Outcomes After Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) Surgery Using Semiconductor Fabric Products

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

Recruiting

Interested in participating?

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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Illinois Bone and Joint Institute

Westmont, Illinois, 60559, United States

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Semiconducting fabric sleeves

Device

This intervention includes semiconductor embedded sleeves that patients will wear for 4 months post-operatively.

Non-semiconducting fabric sleeves

Device

This intervention includes sleeves absent of semiconductors that will be worn for 4 months post-operatively.

Primary outcomes

  1. 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

  1. Effusion Measurements

    Time frame: 1 year

    Effusion is measured by taking the circumference using a soft measuring tape at the following points:

    • Mid thigh: distance from palpation of Anterior Superior Iliac Spine (ASIS) to superior pole of patella, divided in half. (cm)
    • Knee: midpoint of the patella. (cm)
    • Mid calf: distance from top of fibular head to bottom of lateral malleolus, divided in half. (cm)
  2. Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires

    Time frame: 1 year

    Visual Analog Scale (VAS) - assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.

  3. Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires

    Time frame: 1 year

    International Knee Documentation Committee (IKDC) - assesses symptoms and function in daily living activities

  4. Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires

    Time frame: 1 year

    Knee Single Assessment Numeric Evaluation (SANE) - assess knee function on a scale of 0 to 100, with 100 representing normal function

  5. Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires

    Time frame: 1 year

    Tegner Activity Scale - assesses work/sport activities level on a scale of 0 to 10, with 0 representing sick leave and 10 representing elite competitive sports.

  6. Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires

    Time frame: 1 year

    Lysholm Scale - assesses pain, instability, locking, swelling, limp, stair-climbing, squatting, and use of support after ligament surgery on a scale of 0 to 100.

  7. Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires

    Time frame: 1 year

    Knee injury and Osteoarthritis Outcome Score Jr (KOOS Jr) - assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems

Study contacts

Contact information is provided by the study sponsor or research team.

Ronak M Patel, MD

CONTACT

[email protected]

6309292249

Sponsors and collaborators

Lead sponsor

Illinois Center for Orthopaedic Research and Education

Other

Collaborators

  • INCREDIWEAR HOLDINGS, INC.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 20, 2025
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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