Anterior Cruciate Ligament (ACL) Reconstruction SurgerySLEEVE-ACLNCT07707128
Bioactive Knee Sleeves After ACL Reconstruction
A study testing Bioactive Knee Sleeve in people with Anterior Cruciate Ligament (ACL) Reconstruction Surgery, run by Western Kentucky Heart and Lung Research Foundation and Educational Trust at 1 site in United States.
Trial summary
This trial is studying the effectiveness of a bioactive knee sleeve to improve swelling and range of motion in the early postoperative ACL reconstruction. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Reconstruction Surgery
- What is being tested?
- Bioactive Knee Sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2021to 1 Feb 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 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- MRI ACL-deficient knee and scheduled for ACLR surgery.
Who cannot join
- Inflammatory rheumatic conditions
- Previous ACLR on either knee
- Multi-ligamentous knee repair/reconstruction required
- Any autoimmune disease
- Worker's compensation claims
- Sickle cell anemia
- Non-English speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
Med Center Health Western Kentucky Heart & Lung
Bowling Green, Kentucky, 42101-2347
About this study
Official title: Bioactive Knee Sleeve Garments After ACL Reconstruction
This trial is studying the effectiveness of a bioactive knee sleeve to improve swelling and range of motion in the early postoperative ACL reconstruction.
- Being tested
- Bioactive Knee Sleeve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioactive Knee SleeveDevice
This is a bioactive sleeve that produces a photobiomodulation (PBM) effect via low-lever laser therapy (LLLT), where light is transmitted at various wavelengths that trigger biochemical changes optimal for reduced inflammation and pain.
| Study group | Role | What they receive |
|---|---|---|
| Sleeve Group | Experimental | Received standard of care for ACLR with the sleeve wear protocol. Receives: Device: Bioactive Knee Sleeve |
| Control Group | No intervention | Received standard of care for ACLR without the sleeve. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swelling
Circumferential girth measurements measured at 4 inches above mid-patellar region, mid-patellar region, and 4 inches below mid-patellar region on the tibia.
Measured: Pre-operative/baseline, 1-week p/o, 1-month p/o, 2-month p/o, 3-month p/o
Range of Motion
Knee flexion and extension measured with standard goniometry.
Measured: Pre-operative/baseline, 1-week p/o, 1-month p/o, 2-month p/o, 3-month p/o
Patient Reported Outcome (PRO) Measures
Questionnaires relevant to pain and perceived function.
Measured: Pre-operative/baseline, 1-week p/o, 1-month p/o, 2-month p/o, 3-month p/o
Secondary outcomes (1)
Gait Speed
Timed 40ft walk test (only allowed to participate if able to ambulate without AD).
Measured: Pre-operative/baseline, 1-week p/o, 1-month p/o, 2-month p/o, 3-month p/o
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start19 Aug 2021
- Primary completion1 Feb 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament (ACL) Reconstruction SurgeryStudies 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
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Kentucky Heart and Lung Research Foundation and Educational Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Challenger Health, LLC
- Responsible party
- Principal investigator, Christopher Brice, Western Kentucky Heart and Lung Research Foundation and Educational Trust
- Investigators
- Melinda Joyce, Doctor of Pharmacy, Study director, Western Kentucky Heart and Lung Research Foundation and Educational Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707128
- Sponsor's protocol ID
- 2021-MAL-ACL
- Acronym
- SLEEVE-ACL
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All IPD (PI-redacted) that underlie results for publication.
Publications
Xavier, Jorden, Daniel Grande, Seth Sherman, Kenneth Zaslav, and James Paci. 2024. "Investigating the Efficacy of Bioactive Sleeves with Embedded Nano-Semiconductors in Alleviating Tendinopathy: An In Vivo Pilot Study." Journal of Orthopaedic Experience & Innovation 5 (2). https://doi.org/10.60118/001c.121294.
Naterstad IF, Joensen J, Bjordal JM, Couppe C, Lopes-Martins RAB, Stausholm MB. Efficacy of low-level laser therapy in patients with lower extremity tendinopathy or plantar fasciitis: systematic review and meta-analysis of randomised controlled trials. BMJ Open. 2022 Sep 28;12(9):e059479. doi: 10.1136/bmjopen-2021-059479.
PubMed 36171024Hopkins JT, Ingersoll CD. Arthrogenic Muscle Inhibition: 20 Years On. J Sport Rehabil. 2022 Jul 13;31(6):665-666. doi: 10.1123/jsr.2022-0200. Print 2022 Aug 1. No abstract available.
PubMed 35894917Haslerud S, Magnussen LH, Joensen J, Lopes-Martins RA, Bjordal JM. The efficacy of low-level laser therapy for shoulder tendinopathy: a systematic review and meta-analysis of randomized controlled trials. Physiother Res Int. 2015 Jun;20(2):108-25. doi: 10.1002/pri.1606. Epub 2014 Dec 2.
PubMed 25450903de Brito Sousa K, Rodrigues MFSD, de Souza Santos D, Mesquita-Ferrari RA, Nunes FD, de Fatima Teixeira da Silva D, Bussadori SK, Fernandes KPS. Differential expression of inflammatory and anti-inflammatory mediators by M1 and M2 macrophages after photobiomodulation with red or infrared lasers. Lasers Med Sci. 2020 Mar;35(2):337-343. doi: 10.1007/s10103-019-02817-1. Epub 2019 May 31.
PubMed 31152259
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioactive Knee Sleeve Garments After ACL Reconstruction
- ClinicalTrials.gov ID
- NCT07707128
- Acronym / sponsor ID
- SLEEVE-ACL / 2021-MAL-ACL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Western Kentucky Heart and Lung Research Foundation and Educational TrustUniversity, hospital or other
- Collaborators
- Challenger Health, LLC
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 16 Jul 2026 (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.
This trial is studying the effectiveness of a bioactive knee sleeve to improve swelling and range of motion in the early postoperative ACL reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleeve Group | Experimental | Device: Bioactive Knee SleeveReceived standard of care for ACLR with the sleeve wear protocol. |
| Control Group | No intervention | –Received standard of care for ACLR without the sleeve. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- MRI ACL-deficient knee and scheduled for ACLR surgery.
Key exclusion criteria (7 listed)
- Inflammatory rheumatic conditions
- Previous ACLR on either knee
- Multi-ligamentous knee repair/reconstruction required
- Any autoimmune disease
- Worker's compensation claims
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 |
|---|---|---|
| Bioactive Knee SleeveThis is a bioactive sleeve that produces a photobiomodulation (PBM) effect via low-lever laser therapy (LLLT), where light is transmitted at various wavelengths that trigger biochemical changes optimal for reduced inflammation and pain. | Device | Sleeve Group |
Primary outcome
Swelling
Time frame: Pre-operative/baseline, 1-week p/o, 1-month p/o, 2-month p/o, 3-month p/o
Circumferential girth measurements measured at 4 inches above mid-patellar region, mid-patellar region, and 4 inches below mid-patellar region on the tibia.
Range of Motion
Time frame: Pre-operative/baseline, 1-week p/o, 1-month p/o, 2-month p/o, 3-month p/o
Knee flexion and extension measured with standard goniometry.
Patient Reported Outcome (PRO) Measures
Time frame: Pre-operative/baseline, 1-week p/o, 1-month p/o, 2-month p/o, 3-month p/o
Questionnaires relevant to pain and perceived function.
1 secondary outcome
Gait Speed
Time frame: Pre-operative/baseline, 1-week p/o, 1-month p/o, 2-month p/o, 3-month p/o
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- BackgroundXavier, Jorden, Daniel Grande, Seth Sherman, Kenneth Zaslav, and James Paci. 2024. "Investigating the Efficacy of Bioactive Sleeves with Embedded Nano-Semiconductors in Alleviating Tendinopathy: An In Vivo Pilot Study." Journal of Orthopaedic Experience & Innovation 5 (2). https://doi.org/10.60118/001c.121294.
- Background: PubMed 36171024Naterstad IF, Joensen J, Bjordal JM, Couppe C, Lopes-Martins RAB, Stausholm MB. Efficacy of low-level laser therapy in patients with lower extremity tendinopathy or plantar fasciitis: systematic review and meta-analysis of randomised controlled trials. BMJ Open. 2022 Sep 28;12(9):e059479. doi: 10.1136/bmjopen-2021-059479.
- Background: PubMed 35894917Hopkins JT, Ingersoll CD. Arthrogenic Muscle Inhibition: 20 Years On. J Sport Rehabil. 2022 Jul 13;31(6):665-666. doi: 10.1123/jsr.2022-0200. Print 2022 Aug 1. No abstract available.
- Background: PubMed 25450903Haslerud S, Magnussen LH, Joensen J, Lopes-Martins RA, Bjordal JM. The efficacy of low-level laser therapy for shoulder tendinopathy: a systematic review and meta-analysis of randomized controlled trials. Physiother Res Int. 2015 Jun;20(2):108-25. doi: 10.1002/pri.1606. Epub 2014 Dec 2.
- Background: PubMed 31152259de Brito Sousa K, Rodrigues MFSD, de Souza Santos D, Mesquita-Ferrari RA, Nunes FD, de Fatima Teixeira da Silva D, Bussadori SK, Fernandes KPS. Differential expression of inflammatory and anti-inflammatory mediators by M1 and M2 macrophages after photobiomodulation with red or infrared lasers. Lasers Med Sci. 2020 Mar;35(2):337-343. doi: 10.1007/s10103-019-02817-1. Epub 2019 May 31.
- Individual participant dataSharing planned: Yes. All IPD (PI-redacted) that underlie results for publication.
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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.
Melinda Joyce, Doctor of Pharmacy study director
Western Kentucky Heart and Lung Research Foundation and Educational Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioactive Knee Sleeve in people with Anterior Cruciate Ligament (ACL) Reconstruction Surgery, run by Western Kentucky Heart and Lung Research Foundation and Educational Trust 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 16 Jul 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Swelling (time frame: Pre-operative/baseline, 1-week p/o, 1-month p/o, 2-month p/o, 3-month p/o). The study lists 3 primary outcomes in all. 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 NCT07707128, which also lists 5 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 16 Jul 2026.