Bioactive Knee Sleeves After ACL Reconstruction (SLEEVE-ACL)

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament (ACL) Reconstruction Surgery
• Intervention / Treatment: Device: Bioactive Knee Sleeve

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101-2347
      • Med Center Health Western Kentucky Heart & Lung

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• MRI ACL-deficient knee and scheduled for ACLR surgery.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleeve Group; Received standard of care for ACLR with the sleeve wear protocol.	Device: Bioactive Knee Sleeve; 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.
No Intervention: Control Group; Received standard of care for ACLR without the sleeve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Pre-operative/baseline, 1-week p/o, 1-month p/o, 2-month p/o, 3-month p/o

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait Speed	Timed 40ft walk test (only allowed to participate if able to ambulate without AD).	Pre-operative/baseline, 1-week p/o, 1-month p/o, 2-month p/o, 3-month p/o

Collaborators and Investigators

• Sponsor: Western Kentucky Heart and Lung Research Foundation and Educational Trust
• Collaborators: Challenger Health, LLC
• Investigators: Study Director: Melinda Joyce, Doctor of Pharmacy, Western Kentucky Heart and Lung Research Foundation and Educational Trust

Publications and helpful links

General Publications

• Haslerud 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.
• 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.
• Hopkins 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.
• de 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2021
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2021-MAL-ACL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD (PI-redacted) that underlie results for publication.
• IPD Sharing Time Frame: Beginning immediately following publication and ending 5 years after publication.
• IPD Sharing Access Criteria: Will be provided upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes