Synovial Fluid Sleep Study

NYU Langone Health20 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Sleep

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

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. 1. Symptoms category consists of 5 questions, ranked from "never" to "always" (0-5). 2. Stiffness category consists of 2 questions, ranked from "none" to "extreme" (0-5). 3. Pain category consists of 9 questions, ranked from "none" to "extreme" (0-5). 4. Function/Daily Living category consists of 17 questions, ranked from "none" to "extreme" (0-5). 5. Function/Sports category consists of 5 questions, ranked from "none" to "extreme" (0-5). 6. 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.

Time frame: Year 2

Secondary Outcomes

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.

Time frame: 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.

Time frame: Year 2

Knee Range of Motion

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

Data from ClinicalTrials.gov

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