Bioactive Knee Sleeves After ACL Reconstruction | NCT07707128 | Trialant

Bioactive Knee Sleeves After ACL Reconstruction | NCT07707128 | Trialant

Sponsor/Collaborators Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	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.
36171024	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.
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