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Melatonin for Post-Surgery Recovery in Osteoarthritis

Phase 1
Waitlist Available
Led By Josh Rozell, MD
Research Sponsored by NYU Langone Health
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 visit 1 (screening visit), visit 2 (2 months post surgery)
Awards & highlights

Summary

This trial will study the effects of melatonin on sleep quality, length of stay, and opioid consumption for patients undergoing hip or knee surgery.

Who is the study for?
This trial is for adults aged 18 to 95 who are scheduled for elective primary total hip or knee replacement surgery and have been medically cleared. It's not suitable for those needing bilateral joint replacements, with mental impairments, psychiatric disorders (except anxiety/depression), non-elective surgeries, diabetes, using calcium channel blockers or antidepressants, or with sleep issues due to other conditions/medications.Check my eligibility
What is being tested?
The study aims to see if taking melatonin after a single hip or knee replacement surgery improves sleep quality, reduces the time spent in the hospital, and lowers the need for opioid painkillers compared to a placebo (a pill without active ingredients).See study design
What are the potential side effects?
Melatonin may cause side effects like morning grogginess, changes in blood pressure and body temperature regulation. However, it's generally considered safe with few mild side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1 (screening visit), visit 2 (2 months post surgery)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 (screening visit), visit 2 (2 months post surgery) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Sleep Disturbance
Change in the quality of sleep
Secondary outcome measures
Change in narcotic consumption patterns
Change in quality of hospital length of stay

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Hip cohortActive Control1 Intervention
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
Group II: Knee cohortActive Control1 Intervention
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
Group III: Hip cohort controlPlacebo Group1 Intervention
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
Group IV: Knee cohort controlPlacebo Group1 Intervention
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

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,379 Previous Clinical Trials
847,870 Total Patients Enrolled
17 Trials studying Osteoarthritis
3,865 Patients Enrolled for Osteoarthritis
Josh Rozell, MDPrincipal InvestigatorNYU Langone Health
Joshua C Rozell, MDPrincipal InvestigatorNYU Langone Health

Media Library

Hip cohort Clinical Trial Eligibility Overview. Trial Name: NCT04795336 — Phase 1
Osteoarthritis Research Study Groups: Hip cohort, Hip cohort control, Knee cohort, Knee cohort control
Osteoarthritis Clinical Trial 2023: Hip cohort Highlights & Side Effects. Trial Name: NCT04795336 — Phase 1
Hip cohort 2023 Treatment Timeline for Medical Study. Trial Name: NCT04795336 — Phase 1
~62 spots leftby Jul 2025
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