Recruiting

Semiconductor Fabric

Sponsor:

Illinois Center for Orthopaedic Research and Education

Code:

NCT06979804

Conditions

ACL Reconstruction

Meniscus Tears

Anterior Cruciate Ligament Rupture

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Not accepted

Interventions

Semiconducting fabric sleeves

Non-semiconducting fabric sleeves

Study Details

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

Conditions

ACL Reconstruction

Meniscus Tears

Anterior Cruciate Ligament Rupture

Study ID

NCT06979804

Start date

Sep 11, 2024

Status verified date

May, 2025

Completion date

Oct 1, 2026

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

135 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control Group

This arm of the study involves the control group who will receive the standard of care.

active comparator: Semiconducting Fabric Sleeve Group

This group will be receiving semiconducting fabric sleeve to be worn post-operatively.

placebo comparator: Placebo Group

This group receives a look-alike sleeve that contains no semiconductor material.

Interventions

Semiconducting fabric sleeves

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

Non-semiconducting fabric sleeves

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

Primary outcome measure

  • Range of motion [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Ronak M Patel, MD

6309292249rpatel@ibji.com

Locations

Illinois Bone and Joint Institute

Recruiting

Westmont, Illinois, United States, 60559

Contacts

rpatel@ibji.com

More Information

Sponsor

Illinois Center for Orthopaedic Research and Education

Last update posted

May 22, 2025

Last verified

May, 2025

Keywords

  • ACL
  • Meniscus tear
  • ACL tear
  • Compression sleeve
  • Semiconductor fabric
  • ACL reconstruction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Illinois Center for Orthopaedic Research and Education on 2025-05-22.