Trials / Completed
CompletedNCT04688099
Synovial Fluid Sleep Study
A Single-center Observational Study of the Relationship Between Sleep, Synovial Fluid Cytokine Profiles, & Outcomes of ACL Reconstruction
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (actual)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2021-09-27
- Primary completion
- 2024-03-29
- Completion
- 2024-03-29
- First posted
- 2020-12-29
- Last updated
- 2024-05-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04688099. Inclusion in this directory is not an endorsement.