Melatonin Use After Primary Total Joint Arthroplasty

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    252
  • sponsor
    NYU Langone Health
Updated on 10 March 2022

Summary

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.

Description

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.

Details
Condition Osteo Arthritis Knee
Treatment Placebo, Melatonin 5 mg
Clinical Study IdentifierNCT04795336
SponsorNYU Langone Health
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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