Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Sleep Disturbance, Total Joint Arthroplasty

In brief

The purpose of this study is to determine whether melatonin when used as a supplement after surgery improves sleep following total joint arthroplasty

Key facts

Study ID

NCT04590742

Run by

Rothman Institute Orthopaedics

People needed

154

Starts

2018-02-27

Expected to finish

2021-11-30

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients who undergo unilateral primary total joint arthroplasty
• Patient willing and able to complete postoperative surveys

You may not qualify if…

• Patients who undergo revision total joint arthroplasty
• Patients who undergo bilateral total joint arthroplasty
• Patients currently taking melatonin supplementation
• Patient has history of substance abuse (drug or alcohol)
• Patient is a workman's comp patient or patient has current litigation pending
• Patient has an allergy to melatonin
• Patient has a history of delirium/psychiatric/depression/on antidepressants
• Patient has a history of insomnia/ on sleep aid medication
• Anyone on warfarin
• Sleep apnea
• Patient discharged to SNF or rehab
• Patients who have inflammatory conditions
• Shift work or night work

Where it is running

• Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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