A Comparison of Outcomes After Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) Surgery Using Semiconductor Fabric Products

NCT06979804 | Recruiting FDA Device

• 1 other identifier: 12178
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Range of motion

  Measured extension and flexion values using a goniometer at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year time points

  1 year

Secondary Outcomes (7)

• Effusion Measurements

  1 year

• Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires

  1 year

• Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires

  1 year

• Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires

  1 year

• Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires

  1 year

Study Arms (3)

Control Group

NO INTERVENTION

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

Semiconducting Fabric Sleeve Group

ACTIVE COMPARATOR

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

Device: Semiconducting fabric sleeves

Placebo Group

PLACEBO COMPARATOR

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

Device: Non-semiconducting fabric sleeves

Interventions

Semiconducting fabric sleeves DEVICE

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

Semiconducting Fabric Sleeve Group

Non-semiconducting fabric sleeves DEVICE

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

Placebo Group

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Illinois Center for Orthopaedic Research and Education: lead
• INCREDIWEAR HOLDINGS, INC.: collaborator

Study Sites (1)

Illinois Bone and Joint Institute

Westmont, Illinois, 60559, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 36622554 BACKGROUND

• 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.

  PMID: 26014120 BACKGROUND

• 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.

  PMID: 38094981 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

Ronak M Patel, MD

CONTACT

6309292249; rpatel@ibji.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sports Medicine Orthopedic Surgeon

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: September 11, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

US (1)