Bioactive Knee Sleeves After ACL Reconstruction

Bioactive Knee Sleeve Garments After ACL Reconstruction

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07707128

Acronym

SLEEVE-ACL

Enrollment

Registered

2026-07-16

Start date

2021-08-19

Completion date

2026-02-01

Last updated

2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament (ACL) Reconstruction Surgery

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.

Interventions

DEVICEBioactive 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Swelling	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	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	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

Measure	Time frame	Description
Gait Speed	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).

Countries

United States

Contacts

STUDY_DIRECTORMelinda Joyce, Doctor of Pharmacy

Western Kentucky Heart and Lung Research Foundation and Educational Trust

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026