NCT04795336

Melatonin Use After Primary Total Joint Arthroplasty

Melatonin Use After Primary Total Joint Arthroplasty: A Randomized, Double Blind Placebo-Controlled Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteo Arthritis Knee

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-12
• Primary completion: 2024-04-01
• Completion: 2024-04-18
• First posted: 2021-03-12
• Last updated: 2025-05-04
• Results posted: 2025-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study