Synovial Fluid Sleep Study

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

NCT04688099•NYU Langone Health

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (1)

NYU Langone Health

New York, New York, United States

Key Dates

Start Date

September 27, 2021

Primary Completion Date

March 29, 2024

Completion Date

March 29, 2024

Last Updated

May 30, 2024

Enrollment

ACTUAL participants

Conditions

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Synovial Fluid Sleep Study

Inclusion Criteria

Exclusion Criteria

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