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Melatonin for Post-Surgery Recovery in Osteoarthritis

N/A
Recruiting
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

Study 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
1,368 Previous Clinical Trials
839,478 Total Patients Enrolled
17 Trials studying Osteoarthritis
3,877 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 — N/A
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 — N/A
Hip cohort 2023 Treatment Timeline for Medical Study. Trial Name: NCT04795336 — N/A

Frequently Asked Questions

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

Are there any available openings for participants in this research endeavor?

"According to the information published on clinicaltrials.gov, this study is currently sourcing participants. The trial was first listed on July 12th 2021 and recently revised on August 12th 2022."

Answered by AI

Are there any related investigations into the Knee cohort?

"At present, there are 24 ongoing clinical trials that focus on Knee cohort with 4 in Phase 3. Houston, Texas is a primary hub for such research but 25 medical centres throughout the USA have studies underway for this patient group."

Answered by AI

Is this trial a pioneering effort in its field?

"The Knee cohort has been under the microscope since 2007, when Eli Lilly and Company sponsored its first trial. After that initial research with 20 subjects was completed in 2007, it received N/A drug approval. Currently 24 studies are being conducted around 12 cities and 9 countries to further explore this field of medicine."

Answered by AI

Are geriatric individuals being included in the sample population of this research?

"Those who are 18 years and above, but below 95 years old, can apply to participate in this trial."

Answered by AI

Is there an opportunity to sign up for this medical experiment?

"To be included in the study, patients must have a knee complaint and an age between 18 and 95 years old. Up to 252 individuals can enroll in this research trial."

Answered by AI

How many test subjects are included in this trial's data set?

"Affirmative. Evidence found on clinicaltrials.gov confirms that this medical experiment, which was initially published on July 12th 2021, is actively enrolling volunteers. 252 individuals must be recruited from 1 particular location for the trial to progress successfully."

Answered by AI

Who else is applying?

What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Melatonin Use After Primary Total Joint Arthroplasty
2021. "Melatonin Use After Primary Total Joint Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04795336.
All > Osteoarthritis > Melatonin
~66 spots leftby Apr 2025
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