ACL ReconstructionNCT06979804
A Comparison of Outcomes After Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) Surgery Using Semiconductor Fabric Products
A study testing Semiconducting fabric sleeves and Non-semiconducting fabric sleeves in people with ACL Reconstruction and Meniscus Tears, run by Illinois Center for Orthopaedic Research and Education at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- ACL Reconstruction, Meniscus Tears, Anterior Cruciate Ligament Rupture
- What is being tested?
- Semiconducting fabric sleeves and Non-semiconducting fabric sleeves
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2024to 25 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Illinois Bone and Joint Institute
Westmont, Illinois, 60559
About this study
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
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?
Read more
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
- Being tested
- Semiconducting fabric sleeves, Non-semiconducting fabric sleeves
- Keywords
- ACL, Meniscus tear, ACL tear, Compression sleeve, Semiconductor fabric, ACL reconstruction
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semiconducting fabric sleevesDevice
This intervention includes semiconductor embedded sleeves that patients will wear for 4 months post-operatively.
Non-semiconducting fabric sleevesDevice
This intervention includes sleeves absent of semiconductors that will be worn for 4 months post-operatively.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Semiconducting fabric sleeves |
| Placebo Group | Placebo comparator | This group receives a look-alike sleeve that contains no semiconductor material. Receives: Device: Non-semiconducting fabric sleeves |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (7)
Effusion Measurements
Effusion is measured by taking the circumference using a soft measuring tape at the following points:
- Mid thigh: distance from palpation of Anterior Superior Iliac Spine (ASIS) to superior pole of patella, divided in half. (cm)
- Knee: midpoint of the patella. (cm)
- Mid calf: distance from top of fibular head to bottom of lateral malleolus, divided in half. (cm)
Measured: 1 year
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.
Measured: 1 year
Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires
International Knee Documentation Committee (IKDC) - assesses symptoms and function in daily living activities
Measured: 1 year
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
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start11 Sep 2024
- Primary completion25 Oct 2026
- Study completion25 Oct 2026
Why it stopped: Unanticipated problems (product issues)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ACL ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Illinois Center for Orthopaedic Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- INCREDIWEAR HOLDINGS, INC.
- Responsible party
- Principal investigator, Ronak M. Patel, Illinois Center for Orthopaedic Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979804
- Sponsor's protocol ID
- 12178
- Status last verified
- Nov 2026
- First submitted
- 12 May 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 36622554Leung 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 26014120Justice 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06979804
- Acronym / sponsor ID
- 12178
- Keywords
- ACL, Meniscus tear, ACL tear, Compression sleeve, Semiconductor fabric, ACL reconstruction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unanticipated problems (product issues)
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Illinois Center for Orthopaedic Research and EducationUniversity, hospital or other
- Collaborators
- INCREDIWEAR HOLDINGS, INC.
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 25 Oct 2026 (actual)
- Study completion
- 25 Oct 2026 (actual)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Semiconducting fabric sleevesThis group will be receiving semiconducting fabric sleeve to be worn post-operatively. |
| Placebo Group | Placebo comparator | Device: Non-semiconducting fabric sleevesThis group receives a look-alike sleeve that contains no semiconductor material. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semiconducting fabric sleevesThis intervention includes semiconductor embedded sleeves that patients will wear for 4 months post-operatively. | Device | Semiconducting Fabric Sleeve Group |
| Non-semiconducting fabric sleevesThis intervention includes sleeves absent of semiconductors that will be worn for 4 months post-operatively. | Device | Placebo Group |
Primary outcome
Range of motion
Time frame: 1 year
Measured extension and flexion values using a goniometer at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year time points
7 secondary outcomes
Effusion Measurements
Time frame: 1 year
Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires
Time frame: 1 year
Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires
Time frame: 1 year
Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires
Time frame: 1 year
Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires
Time frame: 1 year
Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires
Time frame: 1 year
Secondary Outcome Measures using Validated patient-reported outcome tools questionnaires
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Unanticipated problems (product issues)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 36622554O'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.
- Background: PubMed 26014120Leung 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.
- Background: PubMed 38094981Justice 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semiconducting fabric sleeves and Non-semiconducting fabric sleeves in people with ACL Reconstruction and Meniscus Tears, run by Illinois Center for Orthopaedic Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unanticipated problems (product issues)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06979804, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.