NCT07707128

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 19, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

3.5 years

First QC Date

July 10, 2026

Last Update Submit

July 10, 2026

Conditions

Anterior Cruciate Ligament (ACL) Reconstruction Surgery

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Gait Speed

    Pre-operative/baseline, 1-week p/o, 1-month p/o, 2-month p/o, 3-month p/o

Study Arms (2)

Sleeve Group

EXPERIMENTAL

Received standard of care for ACLR with the sleeve wear protocol.

Device: Bioactive Knee Sleeve

Control Group

NO INTERVENTION

Received standard of care for ACLR without the sleeve.

Interventions

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.

Sleeve Group

Eligibility Criteria

Age16 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Med Center Health Western Kentucky Heart & Lung

Bowling Green, Kentucky, 42101-2347, United States

Location

Related Publications (5)

  • 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.

    BACKGROUND

  • 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.

    PMID: 36171024BACKGROUND

  • 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.

    PMID: 35894917BACKGROUND

  • 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.

    PMID: 25450903BACKGROUND

  • 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.

    PMID: 31152259BACKGROUND

Study Officials

  • Melinda Joyce, Doctor of Pharmacy

    Western Kentucky Heart and Lung Research Foundation and Educational Trust

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, DPT

Study Record Dates

First Submitted

July 10, 2026

First Posted

July 16, 2026

Study Start

August 19, 2021

Primary Completion

February 1, 2025

Study Completion

February 1, 2026

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

All IPD (PI-redacted) that underlie results for publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Beginning immediately following publication and ending 5 years after publication.
Access Criteria
Will be provided upon reasonable request.

Locations

US(1)