SleepNCT04688099
Synovial Fluid Sleep Study
An observational study of Sleep, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2021to 29 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be adults with acute ACL tear undergoing primary reconstruction with BPTB autograft
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center Observational Study of the Relationship Between Sleep, Synovial Fluid Cytokine Profiles, & Outcomes of ACL Reconstruction
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
- Sleep
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- Symptoms category consists of 5 questions, ranked from "never" to "always" (0-5).
- Stiffness category consists of 2 questions, ranked from "none" to "extreme" (0-5).
- Pain category consists of 9 questions, ranked from "none" to "extreme" (0-5).
- Function/Daily Living category consists of 17 questions, ranked from "none" to "extreme" (0-5).
- Function/Sports category consists of 5 questions, ranked from "none" to "extreme" (0-5).
- 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.
Measured: Year 2
Secondary outcomes (5)
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.
Measured: 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.
Measured: Year 2
Knee Range of Motion
Knee range of motion (maximal flexion and extension) will be measured bilaterally using a goniometer.
Measured: Year 1
Thigh Circumference
Thigh circumference will be measured bilaterally.
Measured: Year 1
Concentration of Synovial Fluid Cytokines
Synovial fluid from the injured knee will be sampled preoperatively, intraoperatively, and postoperatively and analyzed for levels of the following pro- and anti-inflammatory cytokines using multiplex magnetic bead immunoassay or ELISA: matrix metalloproteinase (MMP) 3, tissue inhibitor of metalloproteinase (TIMP) 1, TIMP-2, interleukin-1 receptor antagonist (IL-1ra), IL-6, monocyte chemotactic protein (MCP) 1, macrophage inflammatory protein (MIP) 1beta/CCL4, RANTES (regulated upon activation, normal T cell expressed and secreted), vascular endothelial growth factor (VEGF), and basic fibroblast growth factor (bFGF/FGF-2).
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start27 Sep 2021
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Strauss, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688099
- Sponsor's protocol ID
- 20-01872
- Status last verified
- May 2024
- First submitted
- 23 Dec 2020
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Observational Study of the Relationship Between Sleep, Synovial Fluid Cytokine Profiles, & Outcomes of ACL Reconstruction
- ClinicalTrials.gov ID
- NCT04688099
- Acronym / sponsor ID
- 20-01872
- Conditions
- Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be adults with acute ACL tear undergoing primary reconstruction with BPTB autograft
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Year 2
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.
5 secondary outcomes
Score on Lysholm Knee Scoring Scale
Time frame: Year 2
VAS Score for Anterior Knee Pain
Time frame: Year 2
Knee Range of Motion
Time frame: Year 1
Thigh Circumference
Time frame: Year 1
Concentration of Synovial Fluid Cytokines
Time frame: Year 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Strauss, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome Score (KOOS) (time frame: Year 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.