Clinical trial NCT06979804: A Comparison of Outcomes After Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) Surgery Using Semiconductor Fabric Products
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ACL Reconstruction
Meniscus Tears
Anterior Cruciate Ligament Rupture
Keywords: ACL
Meniscus tear
ACL tear
Compression sleeve
Semiconductor fabric
ACL reconstruction
Lead sponsor: Illinois Center for Orthopaedic Research and Education
Sponsor class: OTHER
Collaborators: name: INCREDIWEAR HOLDINGS, INC.
First posted: 2025-05-20
Enrollment: 135
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Range of motion
timeFrame: 1 year
Secondary outcomes:
measure: Effusion Measurements
timeFrame: 1 year
measure: Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires
timeFrame: 1 year
measure: Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires
timeFrame: 1 year
measure: Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires
timeFrame: 1 year
measure: Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires
timeFrame: 1 year
measure: Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires
timeFrame: 1 year
measure: Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires
timeFrame: 1 year
Other outcomes:
Locations:
city: Westmont
country: United States
facility: Illinois Bone and Joint Institute
state: Illinois
Study officials:
References:
citation: O'Riordan SF, Bishop DJ, Halson SL, Broatch JR. Do Sports Compression Garments Alter Measures of Peripheral Blood Flow? A Systematic Review with Meta-Analysis. Sports Med. 2023 Feb;53(2):481-501. doi: 10.1007/s40279-022-01774-0. Epub 2023 Jan 9.
citation: Leung TK. In Vitro and In Vivo Studies of the Biological Effects of Bioceramic (a Material of Emitting High Performance Far-Infrared Ray) Irradiation. Chin J Physiol. 2015 Jun 30;58(3):147-55. doi: 10.4077/CJP.2015.BAD294.
citation: Justice TE, Jacob PB. Non-compressive sleeves versus compression stockings after total knee arthroplasty: A prospective pilot study. J Orthop. 2023 Nov 24;49:102-106. doi: 10.1016/j.jor.2023.11.044. eCollection 2024 Mar.