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TerminatedNCT06979804Updated Nov 6, 2026

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

An interventional study of Semiconducting fabric sleeves and Non-semiconducting fabric sleeves in ACL Reconstruction, Meniscus Tears and Anterior Cruciate Ligament Rupture, sponsored by Illinois Center for Orthopaedic Research and Education. Terminated at 1 site in United States. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Illinois Center for Orthopaedic Research and Education · Not applicable, Interventional, and Treatment

Why this study was terminated
Unanticipated problems (product issues)

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Sep 2024, registered May 2025).
Updated Nov 6, 2026Now TerminatedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
16 Years to 65 Years
Sex
All
01

Study 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
02

Conditions studied

  • ACL Reconstruction
  • Meniscus Tears
  • Anterior Cruciate Ligament Rupture

Keywords

  • ACL
  • Meniscus tear
  • ACL tear
  • Compression sleeve
  • Semiconductor fabric
  • ACL reconstruction
03

In context

Anterior Cruciate Ligament Injuries

625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.

This study's enrollment of 81 is above the median of 56 across 458 interventional studies indexed under Anterior Cruciate Ligament Injuries.

Browse Anterior Cruciate Ligament Injuries studies →

Lead sponsor

Illinois Center for Orthopaedic Research and Education is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing ACL or ACL+Meniscus surgery
  • Age 16 - 65
  • Patients with (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

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 > 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
81 participants (actual)

Study arms

  • No intervention
    Control Group

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

  • Active comparator
    Semiconducting Fabric Sleeve Group

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

    Device: Semiconducting fabric sleeves

  • Placebo comparator
    Placebo Group

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

    Device: Non-semiconducting fabric sleeves

Interventions

  • DeviceSemiconducting fabric sleeves

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

  • DeviceNon-semiconducting fabric sleeves

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

06

What researchers measure

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

    Time frame: 1 year

Secondary outcomes

  1. Effusion Measurements

    Effusion is measured by taking the circumference using a soft measuring tape at the following points: 1. Mid thigh: distance from palpation of Anterior Superior Iliac Spine (ASIS) to superior pole of patella, divided in half. (cm) 2. Knee: midpoint of the patella. (cm) 3. Mid calf: distance from top of fibular head to bottom of lateral malleolus, divided in half. (cm)

    Time frame: 1 year

  2. Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires

    Visual Analog Scale (VAS) - assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.

    Time frame: 1 year

  3. Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires

    International Knee Documentation Committee (IKDC) - assesses symptoms and function in daily living activities

    Time frame: 1 year

  4. Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires

    Knee Single Assessment Numeric Evaluation (SANE) - assess knee function on a scale of 0 to 100, with 100 representing normal function

    Time frame: 1 year

  5. Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires

    Tegner Activity Scale - assesses work/sport activities level on a scale of 0 to 10, with 0 representing sick leave and 10 representing elite competitive sports.

    Time frame: 1 year

  6. Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires

    Lysholm Scale - assesses pain, instability, locking, swelling, limp, stair-climbing, squatting, and use of support after ligament surgery on a scale of 0 to 100.

    Time frame: 1 year

  7. Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires

    Knee injury and Osteoarthritis Outcome Score Jr (KOOS Jr) - assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems

    Time frame: 1 year

07

Study locations

1 site
  • Illinois Bone and Joint Institute
    Westmont, Illinois 60559, United States
08

References and documents

Publications

  • 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. PubMed 36622554 ↗
  • 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. PubMed 26014120 ↗
  • 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. PubMed 38094981 ↗
09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Terminated Unanticipated problems (product issues)
changed Nov 6, 2026
Primary completion
May 1, 2026→Oct 25, 2026 (actual)
Nov 6, 2026
Study completion
Oct 1, 2026→Oct 25, 2026 (actual)
Nov 6, 2026
Enrollment
135 (estimated)→81 (actual)
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Recruiting→Terminated
    Why stopped Unanticipated problems (product issues)
    Primary completion May 1, 2026→Oct 25, 2026 (now actual)
    Study completion Oct 1, 2026→Oct 25, 2026 (now actual)
    Enrollment 135 (estimated)→81 (actual)
    + 4 other changes: index terms, verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06979804
Lead sponsor
Illinois Center for Orthopaedic Research and Education
Collaborators
INCREDIWEAR HOLDINGS, INC.
Responsible party
Ronak M. Patel (Sports Medicine Orthopedic Surgeon, Illinois Center for Orthopaedic Research and Education) — Principal investigator
First posted
May 20, 2025
Start date
Sep 11, 2024
Primary completion
Oct 25, 2026
Completion
Oct 25, 2026
Last update
Nov 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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