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Melatonin 5 mg for Joint Replacement Surgery

N/A

Waitlist Available

Led By Alejandro G Della Valle, MD

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-year

Awards & highlights

Study Summary

This trial will compare the effects of melatonin vs. placebo in patients undergoing primary total knee arthroplasty. The goal is to see if melatonin can improve postoperative sleep quality and if improved sleep quality correlates to better postoperative outcomes.

Eligible Conditions

Joint Replacement Surgery
Sleep Disorders
Replacement
Knee

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sleep Quality

Secondary outcome measures

Knee Function

Lower Extremity Activity

Opioids Prescribed

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Melatonin Group (Experimental)Experimental Treatment1 Intervention

Patients who will take one (1) 5mg Melatonin tablet 30 minutes before bedtime daily for the 6 weeks following surgery.

Group II: Placebo Group (Control)Placebo Group1 Intervention

Patients who will take one (1) placebo (Vitamin C) tablet 30 minutes before bedtime daily for the 6 weeks following surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melatonin 5 mg

2016

Completed Phase 4

~250

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Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor

243 Previous Clinical Trials

59,188 Total Patients Enrolled

Alejandro G Della Valle, MDPrincipal InvestigatorHospital for Special Surgery, New York

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can patients currently join this clinical exploration?

"Data hosted on clinicaltrials.gov indicates that this trial, which was first unveiled on January 10th 2022, is currently seeking participants. The page was last updated on August 25th 2022."

Answered by AI

What is the sample size for this clinical experiment?

"Affirmative, according to clinicaltrials.gov this medical investigation is actively seeking volunteers. It was first made available on the 10th of January 2022 and recently updated on the 25th of August 2022. 152 participants are needed at 1 site for inclusion in this trial."

Answered by AI