Phase 1
Completed N=294
Melatonin Use After Primary Total Joint Arthroplasty
Osteo Arthritis Knee
Source: ClinicalTrials.gov NCT04795336 ↗
Enrolled (actual)
294
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS) — 7.2; 6.2; 6; 6.8 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS) |
7.2; 6.2; 6; 6.8 | — |
| SECONDARY Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score |
4.6; 4; 0.3; 2.1 | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT04795336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.