Comparing outcomes of ACL surgery with semiconductor fabric sleeves

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

This study is testing if wearing special fabric sleeves can help people recover better and faster after ACL or ACL plus Meniscus surgery compared to regular sleeves.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 135 (estimated)
• Ages: 16 Years to 65 Years
• Sex: All
• Sponsor: Illinois Center for Orthopaedic Research and Education (other)
• Locations: 1 site (Westmont, Illinois)
• Trial ID: NCT06979804 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of semiconductor fabric sleeves in improving outcomes for patients undergoing Anterior Cruciate Ligament (ACL) or ACL plus Meniscus surgery. Participants will be randomly assigned to wear either semiconductor sleeves or placebo sleeves for a total of 16 weeks, during which their functional recovery will be assessed through patient-reported outcomes and clinical measurements. The study seeks to determine if the semiconductor sleeves lead to better functional outcomes and faster recovery compared to the placebo.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 16 to 65 who are scheduled for ACL or ACL+Meniscus surgery and have a BMI under 40.

Not a fit: Patients with neurological conditions, severe medical issues, or prior knee surgeries in the last five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel non-invasive method to enhance recovery and functional outcomes for ACL surgery patients.

How similar studies have performed: While the use of semiconductor materials in medical applications is emerging, this specific approach has not been widely tested in similar studies.

Eligibility criteria

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.

Where this trial is running

Westmont, Illinois

• Illinois Bone and Joint Institute — Westmont, Illinois, United States (RECRUITING)

Study contacts

• Study coordinator: Ronak M Patel, MD

Conditions: ACL Reconstruction, Meniscus Tears, Anterior Cruciate Ligament Rupture, ACL, Meniscus tear, ACL tear, Compression sleeve, Semiconductor fabric