Synovial Fluid Sleep Study

Study Overview
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Brief Summary
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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.

Official Title
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A Single-center Observational Study of the Relationship Between Sleep, Synovial Fluid Cytokine Profiles, & Outcomes of ACL Reconstruction

Conditions
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Sleep

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Undergoing primary ACL reconstruction with BPTB autograft for acute ACL tear, with or without concomitant meniscectomy Presenting within 2 weeks of injury and undergoing reconstruction within 8 weeks of injury Exclusion Criteria: History of blood-borne diseases including HIV, HBV, HCV, HTLV, or syphilis Pregnant Multiligamentous knee injury Concomitant meniscal repair, meniscal allograft transplantation, osteotomy, or repair of focal chondral defect (e.g., osteochondral autograft transfer system, osteochondral allograft, matrix-induced autologous chondrocyte implantation) Prior ipsilateral knee surgeries or injuries Primary sleep disorders including insomnia, sleep apnea, or restless legs syndrome Uncontrolled psychiatric disorders with sleep disturbance Night shift work Travel with time zone change within three weeks of surgery Systemic inflammatory disease Autoimmune disease Immunomodulatory drug use Chemotherapy within a year before surgery Intra-articular injection within 3 months before surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. Symptoms category consists of 5 questions, ranked from never to always (0-5). Stiffness category consists of 2 questions, ranked from none to extreme (0-5). Pain category consists of 9 questions, ranked from none to extreme (0-5). Function/Daily Living category consists of 17 questions, ranked from none to extreme (0-5). Function/Sports category consists of 5 questions, ranked from none to extreme (0-5). 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Lysholm Knee Scoring Scale | The Lysholm Knee Scoring Scale consists of 35 common complaints which people frequently have with their knee problems. Participants will check each statement which best describes their condition -- each statement is assigned a particular score, and those scores are added together to obtain the total score out of 100 (total range: 0-100). A higher score indicates more knee problems. | Year 2 | 
| VAS Score for Anterior Knee Pain | The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain. The total score range is 0-10; the higher the score, the worse the pain. | Year 2 | 
| Knee Range of Motion | Knee range of motion (maximal flexion and extension) will be measured bilaterally using a goniometer. | Year 1 | 
| Thigh Circumference | Thigh circumference will be measured bilaterally. | Year 1 | 
| Concentration of Synovial Fluid Cytokines | Synovial fluid from the injured knee will be sampled preoperatively, intraoperatively, and postoperatively and analyzed for levels of the following pro- and anti-inflammatory cytokines using multiplex magnetic bead immunoassay or ELISA: matrix metalloproteinase (MMP) 3, tissue inhibitor of metalloproteinase (TIMP) 1, TIMP-2, interleukin-1 receptor antagonist (IL-1ra), IL-6, monocyte chemotactic protein (MCP) 1, macrophage inflammatory protein (MIP) 1beta/CCL4, RANTES (regulated upon activation, normal T cell expressed and secreted), vascular endothelial growth factor (VEGF), and basic fibroblast growth factor (bFGF/FGF-2). | Year 1 |