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Completed

NCT Number: NCT04688099

Synovial Fluid Sleep Study

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.

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Key information

Conditions

Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10003, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Year 2

    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.

Secondary outcomes

  1. Score on Lysholm Knee Scoring Scale

    Time frame: Year 2

    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.

  2. VAS Score for Anterior Knee Pain

    Time frame: Year 2

    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.

  3. Knee Range of Motion

    Time frame: Year 1

    Knee range of motion (maximal flexion and extension) will be measured bilaterally using a goniometer.

  4. Thigh Circumference

    Time frame: Year 1

    Thigh circumference will be measured bilaterally.

  5. Concentration of Synovial Fluid Cytokines

    Time frame: Year 1

    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).

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 29, 2020
Registry last updated
May 30, 2024

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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