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Completed

NCT Number: NCT07707128

Bioactive Knee Sleeves 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.

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Key information

Conditions

Anterior Cruciate Ligament (ACL) Reconstruction Surgery

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Med Center Health Western Kentucky Heart & Lung

Bowling Green, Kentucky, 42101-2347, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bioactive Knee Sleeve

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Gait Speed

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

    Timed 40ft walk test (only allowed to participate if able to ambulate without AD).

Sponsors and collaborators

Lead sponsor

Western Kentucky Heart and Lung Research Foundation and Educational Trust

Other

Collaborators

  • Challenger Health, LLC

Registry information

Official study title

Bioactive Knee Sleeve Garments After ACL Reconstruction

Acronym: SLEEVE-ACL

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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