Back to resultsMelatonin Use After Primary Total Joint Arthroplasty
Primary Purpose
Osteo Arthritis Knee
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melatonin 5 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee
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)
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Arm Label
Knee cohort
Knee cohort control
Hip cohort
Hip cohort control
Arm Description
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
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
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
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
Outcomes
Primary Outcome Measures
Change in Sleep Disturbance
The primary objective is the Epworth Sleep Score used to evaluate the impact of melatonin use on the quality of sleep, including total hours of sleep and nighttime awakenings in patients undergoing elective primary total hip and knee arthroplasty.The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Change in the quality of sleep
Measured by the patient reported survey on quality of sleep. Stanford Sleepiness Scale (SSS) uses a 7-point Likert scale to quantify a patient's sleepiness at the time the questionnaire is completed.
Secondary Outcome Measures
Change in quality of hospital length of stay
To investigate hospital length of stay in patients who take melatonin as a sleep aid for 14 days after surgery. Measured by patient reported outcome questionnaires.
Change in narcotic consumption patterns
Narcotic consumption patterns in patients who take melatonin as a sleep aid for 14 days after surgery. Opioid consumption will be measured based on in-patient pain medications given following surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04795336
Brief Title
Melatonin Use After Primary Total Joint Arthroplasty
Official Title
Melatonin Use After Primary Total Joint Arthroplasty: A Randomized, Double Blind Placebo-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
This will be a single-center randomized double blind placebo control clinical trial. In the cohort of patients undergoing primary elective total hip and 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 1:1 divided into intervention group and placebo group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
252 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Knee cohort
Arm Type
Active Comparator
Arm Description
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
Arm Title
Knee cohort control
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Hip cohort
Arm Type
Active Comparator
Arm Description
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
Arm Title
Hip cohort control
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Melatonin 5 mg
Intervention Description
Melatonin is a widely sold synthetic molecule in various forms including tablets, gummies and liquid. In the present study, the tablet version of the medication will be used at a dose of 5mg
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.
Primary Outcome Measure Information:
Title
Change in Sleep Disturbance
Description
The primary objective is the Epworth Sleep Score used to evaluate the impact of melatonin use on the quality of sleep, including total hours of sleep and nighttime awakenings in patients undergoing elective primary total hip and knee arthroplasty.The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Time Frame
Visit 1 (Screening Visit), Visit 2 (2 months post surgery)
Title
Change in the quality of sleep
Description
Measured by the patient reported survey on quality of sleep. Stanford Sleepiness Scale (SSS) uses a 7-point Likert scale to quantify a patient's sleepiness at the time the questionnaire is completed.
Time Frame
Visit 1 (Screening Visit), Visit 2 (2 months post surgery)
Secondary Outcome Measure Information:
Title
Change in quality of hospital length of stay
Description
To investigate hospital length of stay in patients who take melatonin as a sleep aid for 14 days after surgery. Measured by patient reported outcome questionnaires.
Time Frame
Visit 1 (Screening Visit), 14 days after surgery visit
Title
Change in narcotic consumption patterns
Description
Narcotic consumption patterns in patients who take melatonin as a sleep aid for 14 days after surgery. Opioid consumption will be measured based on in-patient pain medications given following surgery.
Time Frame
Visit 1 (Screening Visit), 14 days after surgery visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Warren
Phone
212-598-6245
Email
Daniel.waren@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua C Rozell, MD
Phone
212-598-6000
Email
Joshua.rozell@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua C Rozell, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Waren
Phone
212-598-6245
Email
daniel.waren@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Joshua C Rozell, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research. The investigator who proposed to use the data.
IPD Sharing Access Criteria
Upon reasonable request. Requests should be directed to Daniel.waren@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Melatonin Use After Primary Total Joint Arthroplasty
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