Synovial Fluid Sleep Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-27

Study Completion Date

2024-03-29

Brief Summary

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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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Detailed Description

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Conditions

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Sleep

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No