Status:
COMPLETED
Synovial Fluid Sleep Study
Lead Sponsor:
NYU Langone Health
Conditions:
Sleep
Eligibility:
All Genders
18+ years
Brief 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 i...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Undergoing primary ACL reconstruction with BPTB autograft for acute ACL tear, with or without concomitant meniscectomy
- Presenting within 2 weeks of injury and undergoing reconstruction within 8 weeks of injury
Exclusion
- History of blood-borne diseases including HIV, HBV, HCV, HTLV, or syphilis
- Pregnant
- Multiligamentous knee injury
- 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)
- Prior ipsilateral knee surgeries or injuries
- Primary sleep disorders including insomnia, sleep apnea, or restless legs syndrome
- Uncontrolled psychiatric disorders with sleep disturbance
- Night shift work
- Travel with time zone change within three weeks of surgery
- Systemic inflammatory disease
- Autoimmune disease
- Immunomodulatory drug use
- Chemotherapy within a year before surgery
- Intra-articular injection within 3 months before surgery
Key Trial Info
Start Date :
September 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 29 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04688099
Start Date
September 27 2021
End Date
March 29 2024
Last Update
May 30 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
NYU Langone Health
New York, New York, United States, 10003