NCT04688099|Completed
Synovial Fluid Sleep Study
A Single-center Observational Study of the Relationship Between Sleep, Synovial Fluid Cytokine Profiles, & Outcomes of ACL Reconstruction
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A Single-center Observational Study of the Relationship Between Sleep, Synovial Fluid Cytokine Profiles, & Outcomes of ACL Reconstruction
Sponsor study identifier
observational
20
1 country
1
Study Start
September 27, 2021
Actual (reported)Primary Completion
March 29, 2024
Actual (reported)Study Completion
March 29, 2024
Actual (reported)This is an observational study of the relationship between perioperative sleep time/quality, synovial fluid cytokine profiles, and clinical outcomes of primary ACL reconstruction with BPTB autograft in 50 subjects. Sleep during the week before and month after surgery will be assessed using Fitbit smartwatch and sleep diary. Synovial fluid sampled preoperatively, intraoperatively, and postoperatively will be analyzed for levels of pro- and anti-inflammatory cytokines. Postoperative knee pain and function will be assessed until 2 years post-op using validated questionnaires.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 29, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 23, 2020
Actual (reported)December 29, 2020
Actual (reported)September 27, 2021
Actual (reported)March 29, 2024
Actual (reported)March 29, 2024
Actual (reported)Knee injury and Osteoarthritis Outcome Score (KOOS)
KOOS is a survey is meant to track how the participant feels about their knee and how well they are able to perform their usual activities. There are six categories in the survey: Symptoms, Stiffness, Pain, Function/Daily Living, Function/Sports, Quality of Life. 1. Symptoms category consists of 5 questions, ranked from "never" to "always" (0-5). 2. Stiffness category consists of 2 questions, ranked from "none" to "extreme" (0-5). 3. Pain category consists of 9 questions, ranked from "none" to "extreme" (0-5). 4. Function/Daily Living category consists of 17 questions, ranked from "none" to "extreme" (0-5). 5. Function/Sports category consists of 5 questions, ranked from "none" to "extreme" (0-5). 6. Quality of Life category consists of 4 questions, ranked from "not at all" to "extremely, constantly, totally" (0-5). The total range of score is 0-210. The lower the score, the better they feel about their knee and performance of usual activities.
Year 2
Score on Lysholm Knee Scoring Scale
Year 2
VAS Score for Anterior Knee Pain
Year 2
Knee Range of Motion
Year 1
Thigh Circumference
Year 1
Concentration of Synovial Fluid Cytokines
Year 1
Participants will be adults with acute ACL tear undergoing primary reconstruction with BPTB autograft
NYU Langone Health
New York, New York, 10003, United States
Synovial fluid
Eric Strauss, MD
NYU Langone Health
20 participants (actual enrollment reported by the registry).
First Submitted
December 23, 2020
First Posted
December 29, 2020
Study Start
September 27, 2021
Actual (reported)Evaluation of SLEEP Program
Contact the study team to confirm eligibility.
Primary Completion
March 29, 2024
Actual (reported)Study Completion
March 29, 2024
Actual (reported)Last Updated
May 30, 2024
Record last verified: 2024-05
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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Source: ClinicalTrials.gov.
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