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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether semiconductor fabric sleeves aid in better and faster recovery after ACL or ACL+meniscus surgery. The study compares these special sleeves to regular ones to determine their effectiveness in improving healing and accelerating the return to normal activities. Eligible participants include those planning to undergo ACL or ACL+meniscus surgery and who can adhere to the trial schedule and guidelines. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance recovery methods for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these semiconductor fabric sleeves are safe for ACL surgery?

Research has shown that semiconductor fabric sleeves are generally well-tolerated. No major side effects have been reported from using these sleeves after ACL surgery. The trial is in a phase that does not focus on safety, indicating that the safety of the sleeves is not a significant concern. Additionally, since these sleeves are compared to a placebo, they likely have a good safety profile. The primary concern might be skin irritation from wearing the sleeve, but previous studies have noted no serious issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using semiconducting fabric sleeves in ACL surgery because these sleeves offer a novel approach to post-operative healing. Unlike standard treatments that rely on traditional physical therapy and pain management, these sleeves incorporate semiconductor materials designed to enhance the recovery process by potentially improving circulation and reducing inflammation. Additionally, the look-alike placebo sleeves help ensure that any observed benefits are due to the semiconductor technology itself, providing clear insights into its effectiveness.

What evidence suggests that semiconductor fabric sleeves are effective for ACL surgery?

This trial will compare the effectiveness of semiconducting fabric sleeves with a control group and a placebo group for recovery after ACL or ACL+Meniscus surgery. Research suggests that special fabric sleeves with tiny electronic components might enhance recovery after knee surgery. Early tests indicate these sleeves could help patients move and strengthen their knees more quickly. The sleeves provide a gentle electrical boost, potentially reducing swelling and aiding healing. While these results are promising, further studies are needed to confirm their benefits. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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

I can follow the study's schedule and rules.

Patients with BMI <40

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06979804

A Comparison of Outcomes After Anterior Cruciate ... The goal of this clinical trial is to determine the effect of semiconductor sleeves on the treatment of Anterior Cruciate Ligament (ACL) or Anterior ...

2. withpower.com withpower.com/trial/semiconductor-fabric-sleeves-for-acl-surgery-2fbe8

Semiconductor Fabric Sleeves for ACL Surgery Trial Overview The study tests if semiconductor fabric sleeves improve recovery from ACL or ACL+Meniscus surgeries better than non-semiconducting placebo ...

3. ctv.veeva.com ctv.veeva.com/study/a-comparison-of-outcomes-after-acl-or-acl-meniscus-surgery-using-semiconductor-fabric-products

A Comparison of Outcomes After Anterior Cruciate Ligament ... The goal of this clinical trial is to determine the effect of semiconductor sleeves on the treatment of Anterior Cruciate Ligament (ACL) or ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6059861/

Anterior Cruciate Ligament Reconstruction with LARS ... The authors reported the lowest cumulative rates of failure with the LARS device (2.6% for ACL and 1% for posterior cruciate ligament surgery). Rates of ...

5. wjgnet.com wjgnet.com/2308-3840/full/v9/i5/411.htm

Current and future of anterior cruciate ligament ... In recent years, ACL reconstruction has generally yielded favorable outcomes. This procedure is a minimally invasive arthroscopic surgery ...