Melatonin Use After Primary Total Joint Arthroplasty

Study Purpose

The purpose of this study is to determine the effect of melatonin supplementation on patient sleep quality, length of stay, and opioid consumption following primary, unilateral, elective total hip or knee arthroplasty.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 95 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patient are current candidates for elective primary total hip and total knee arthroplasty.

- Patients ≥18 years of age but ≤ 95.

- Patients have been medically cleared and scheduled for surgery.

Exclusion Criteria:

- Non-elective conversion arthroplasty.

- Bilateral total joint arthroplasty.

- Contraindications to use of melatonin (diabetes, calcium channel blocker use, depression) - Conditions and medications likely to confound results due to impact on subjective and/or objective sleep quality (insomnia, drug/alcohol abuse, and use of benzodiazepines, and prescription sleep aids) - Conditions likely to impair capacity to adhere to protocol (mental impairment, psychiatric disorders other than anxiety/depression)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04795336
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	NYU Langone Health
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Joshua C Rozell, MD
Principal Investigator Affiliation	NYU Langone Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteo Arthritis Knee

Additional Details

This will be a single-center randomized double blind placebo control clinical trial. In the cohort of patients undergoing primary elective total hip and the cohort of patients undergoing primary elective knee arthroplasty, participants are recruited from those who are willing to consent and participate in the study, and will be randomly 1:1 divided into intervention group and placebo group.

Arms & Interventions

Arms

Active Comparator: Knee cohort

In the cohort of patients undergoing primary elective knee arthroplasty, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days

Placebo Comparator: Knee cohort control

In the cohort of patients undergoing primary elective knee arthroplasty, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into placebo group. Control group will receive a placebo pill for 14 days

Active Comparator: Hip cohort

In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days

Placebo Comparator: Hip cohort control

In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into placebo group. Control group will receive a placebo pill for 14 days

Interventions

Drug: - Melatonin 5 mg

Melatonin is a widely sold synthetic molecule in various forms including tablets, gummies and liquid. In the present study, the tablet version of the medication will be used at a dose of 5mg

Other: - Placebo

The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

NYU Langone Health, New York, New York

Status

Recruiting

Address

NYU Langone Health

New York, New York, 10016

Site Contact

Daniel Waren

[email protected]

212-598-6245

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