Semiconductor Fabric Sleeves for ACL Surgery

Overseen By Ronak M Patel, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Illinois Center for Orthopaedic Research and Education

Disqualifiers: Neurological, Heart, Auto-immune, Diabetes, others

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

135 Participants Needed

Trial Summary

What is the purpose of 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

This trial is for individuals who have had surgery to repair a torn anterior cruciate ligament (ACL) or ACL along with a meniscus tear. Participants must be willing to wear special leg and knee sleeves after their surgery and complete surveys about their recovery.

Inclusion Criteria

Patients with BMI <40

I can follow the study's schedule and rules.

Patients who are willing and able to sign corresponding research subject consent/assent form

Exclusion Criteria

I have a neurological condition like multiple sclerosis or Parkinson's.

Patient has auto-immune or auto-inflammatory diseases

Patient has BMI > 39.9

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear semiconductor or placebo leg sleeve for 4 weeks and knee sleeve for the following 12 weeks

16 weeks

Regular follow-up visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including range of motion and effusion measurements

36 weeks

Visits at 3 months, 6 months, and 1 year

Treatment Details

Interventions

• ACL or ACL+Meniscus Surgery

Trial Overview The study tests if semiconductor fabric sleeves improve recovery from ACL or ACL+Meniscus surgeries better than non-semiconducting placebo sleeves. Patients will be randomly assigned to wear either the semiconductor sleeve or the placebo, following up with outcome surveys.

Participant Groups

Group I: Control Group Active Control 1 Intervention

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

Group II: Semiconducting Fabric Sleeve Group Active Control 1 Intervention

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

Group III: Placebo Group Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Illinois Center for Orthopaedic Research and Education

Lead Sponsor

Trials

2

Recruited

90+

INCREDIWEAR HOLDINGS, INC.

Industry Sponsor

Trials

6

Recruited

630+