Synovial Fluid Sleep Study

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04688099
• Other study ID #: 20-01872
• Status: Enrolling by invitation
• Start date: September 27, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: July 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Knee Range of Motion	Knee range of motion (maximal flexion and extension) will be measured bilaterally using a goniometer.	Year 1
Secondary	Thigh Circumference	Thigh circumference will be measured bilaterally.	Year 1
Secondary	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