---
title: Melatonin Use After Primary Total Joint Arthroplasty
nct_id: NCT04795336
overall_status: COMPLETED
phase: PHASE1
sponsor: NYU Langone Health
study_type: INTERVENTIONAL
primary_condition: Osteo Arthritis Knee
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04795336.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04795336"
ct_last_update_post_date: 2025-05-04
last_seen_at: "2026-05-12T07:21:06.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Melatonin Use After Primary Total Joint Arthroplasty

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

**NCT ID:** [NCT04795336](https://clinicaltrials.gov/study/NCT04795336)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 294
- **Lead Sponsor:** NYU Langone Health
- **Conditions:** Osteo Arthritis Knee
- **Start Date:** 2021-07-12
- **Completion Date:** 2024-04-18
- **CT.gov Last Update:** 2025-05-04

## 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.

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 95 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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)
```

## Arms

- **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
- **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
- **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
- **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

## 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
- **Placebo** (OTHER) — The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.

## Primary Outcomes

- **Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS)** _(time frame: Visit 1 (Screening Visit), Visit 2 (2 months post surgery))_ — 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'.

## Secondary Outcomes

- **Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score** _(time frame: Visit 1 (Screening Visit), 14 days after surgery visit)_

## Locations (1)

- NYU Langone Health, New York, New York, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.nyu langone health|new york|new york|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT04795336*  
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