Synovial Fluid Sleep Study

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be adults with acute ACL tear undergoing primary reconstruction with BPTB autograft

Description

Inclusion Criteria:

1. At least 18 years of age
2. Undergoing primary ACL reconstruction with BPTB autograft for acute ACL tear, with or without concomitant meniscectomy
3. Presenting within 2 weeks of injury and undergoing reconstruction within 8 weeks of injury

Exclusion Criteria:

1. History of blood-borne diseases including HIV, HBV, HCV, HTLV, or syphilis
2. Pregnant
3. Multiligamentous knee injury
4. 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)
5. Prior ipsilateral knee surgeries or injuries
6. Primary sleep disorders including insomnia, sleep apnea, or restless legs syndrome
7. Uncontrolled psychiatric disorders with sleep disturbance
8. Night shift work
9. Travel with time zone change within three weeks of surgery
10. Systemic inflammatory disease
11. Autoimmune disease
12. Immunomodulatory drug use
13. Chemotherapy within a year before surgery
14. Intra-articular injection within 3 months before surgery

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Eric Strauss, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Actual): March 29, 2024
• Study Completion (Actual): March 29, 2024

Study Registration Dates

• First Submitted: December 23, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 20-01872

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to eric.strauss@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No