Osteo Arthritis Knee
Conditions
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.
Interventions
DRUGMelatonin 5 mg
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
OTHERPlacebo
The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS) | Visit 1 (Screening Visit), Visit 2 (2 months post surgery) | 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'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Visit 1 (Screening Visit), 14 days after surgery visit | The PROMIS Sleep Disturbance questionnaire comprises 8 items assessing patients' sleep over the past 7 days. Each item is rated on a Likert scale from 1-5. The raw score is the sum of responses and is transformed to a normalized score from 0-100; higher scores indicate greater sleep disturbance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Knee Cohort 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
Melatonin 5 mg: 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 | 64 |
| Knee Cohort Control 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
Placebo: The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1. | 64 |
| Hip Cohort 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
Melatonin 5 mg: 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 | 75 |
| Hip Cohort Control 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
Placebo: The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1. | 64 |
| Total | 267 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Did not take study medication | 2 | 0 | 0 | 0 |
| Overall Study | Lost study logs | 0 | 1 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 4 | 3 | 12 |
Baseline characteristics
| Characteristic | Knee Cohort | Total | Hip Cohort Control | Hip Cohort | Knee Cohort Control |
|---|---|---|---|---|---|
| Age, Continuous | 64.1 years | 63.9 years | 62.6 years | 62.7 years | 67.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 8 Participants | 5 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 64 Participants | 259 Participants | 59 Participants | 72 Participants | 64 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 13 Participants | 3 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 43 Participants | 6 Participants | 10 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 30 Participants | 9 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) White | 43 Participants | 181 Participants | 46 Participants | 54 Participants | 38 Participants |
| Region of Enrollment United States | 64 participants | 267 participants | 64 participants | 75 participants | 64 participants |
| Sex: Female, Male Female | 48 Participants | 177 Participants | 40 Participants | 48 Participants | 41 Participants |
| Sex: Female, Male Male | 16 Participants | 90 Participants | 24 Participants | 27 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 64 | 0 / 75 | 0 / 64 |
| other Total, other adverse events | 0 / 64 | 0 / 64 | 0 / 75 | 0 / 64 |
| serious Total, serious adverse events | 0 / 64 | 0 / 64 | 0 / 75 | 0 / 64 |
Outcome results
Primary
Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS)
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Knee Cohort | Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS) | 7.2 score on a scale | Standard Deviation 4.4 |
| Knee Cohort Control | Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS) | 6.2 score on a scale | Standard Deviation 4.1 |
| Hip Cohort | Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS) | 6 score on a scale | Standard Deviation 4 |
| Hip Cohort Control | Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS) | 6.8 score on a scale | Standard Deviation 4.5 |
Secondary
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
The PROMIS Sleep Disturbance questionnaire comprises 8 items assessing patients' sleep over the past 7 days. Each item is rated on a Likert scale from 1-5. The raw score is the sum of responses and is transformed to a normalized score from 0-100; higher scores indicate greater sleep disturbance.
Time frame: Visit 1 (Screening Visit), 14 days after surgery visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Knee Cohort | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | 4.6 score on a scale | Standard Deviation 8.2 |
| Knee Cohort Control | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | 4 score on a scale | Standard Deviation 8.4 |
| Hip Cohort | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | 0.3 score on a scale | Standard Deviation 9.8 |
| Hip Cohort Control | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | 2.1 score on a scale | Standard Deviation 9.8 |