Melatonin Use After Primary Total Joint Arthroplasty

NCT04795336 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 20-02030
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS)

  The primary objective is the Epworth Sleep Score used to evaluate the impact of melatonin use on the quality of sleep, including total hours of sleep and nighttime awakenings in patients undergoing elective primary total hip and knee arthroplasty. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.

  Visit 1 (Screening Visit), Visit 2 (2 months post surgery)

Secondary Outcomes (1)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score

  Visit 1 (Screening Visit), 14 days after surgery visit

Study Arms (4)

Knee cohort

ACTIVE COMPARATOR

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

Drug: Melatonin 5 mg

Knee cohort control

PLACEBO COMPARATOR

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

Other: Placebo

Hip cohort

ACTIVE COMPARATOR

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

Drug: Melatonin 5 mg

Hip cohort control

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Melatonin 5 mg DRUG

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

Hip cohort; Knee cohort

Placebo OTHER

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

Hip cohort control; Knee cohort control

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Joshua C Rozell, MD
• Organization: NYU Langone Health

Joshua.rozell@nyulangone.org

212-598-6000

Study Officials

• Joshua C Rozell, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 12, 2021
• Study Start: July 12, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 18, 2024
• Last Updated: May 4, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research. The investigator who proposed to use the data.
• Access Criteria: Upon reasonable request. Requests should be directed to Daniel.waren@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)