This randomized controlled trial (RCT) will compare the effects of melatonin vs. placebo in patients undergoing primary total knee arthroplasty (TKA). This RCT aims to study the effects melatonin has on sleep quality after TKA. Patients will be blinded to their respective groups and will be instructed to take either 5mg melatonin or a placebo pill (Vitamin C) for 6 weeks postoperative. Sleep quality surveys will be administered preoperatively and post-operative week 6, 90-days and 1 year. Poor sleep quality is a common issue faced by patients undergoing TKA. The goal of this study is see if melatonin can improve postoperative sleep quality, and if so, does improved sleep quality correlate to improvements in other postoperative outcomes.
This study will compare postoperative sleep quality in two groups of patients undergoing primary total knee arthroplasty (TKA): * Group 1 will take one melatonin (5 mg) tablet nightly, \~30 minutes before bedtime during the 6 week postoperative period * Group 2 will take one placebo (5 mg Vitamin C) tablet nightly, \~30 minutes before bedtime during the 6 week postoperative period The primary outcome will be sleep quality at 6 weeks. Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). The survey will be administered preoperatively, 6-weeks, 90-days and 1 year postoperatively. Preoperative surveys will be completed in-person, on-site by study participants. All postoperative surveys will be distributed via email. Secondary outcomes include: * (KOOS Jr, LEAS, VR-12, VAS) administered preoperatively, at 6-weeks, 90-days and 1-year post-operatively. * Total opioids prescribed in first 3 months postoperative will be collected using iStop * Frequency of CMS defined surgicalcomplications in the first 90-days after primary TKA. * Adverse events of Melatonin during the first 6 weeks (collected via email survey sent to participants once per week, for the first 6 weeks) * Study medication compliance at 6 weeks (collected via email survey sent to participants once per week, for the first 6 weeks)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
176
Participants will be taking one 5 mg tablet of Melatonin 30 minutes before bedtime nightly, for 6 weeks following their knee replacement surgeries.
Participants will be taking one placebo tablet 30 minutes before bedtime nightly, for 6 weeks following their knee replacement surgeries.
Hospital for Special Surgery
New York, New York, United States
Sleep Quality
Assessed based on self-reported data collected using the Pittsburgh Sleep Quality Index (PSQI). Minimum Score: 0; Maximum Score: 21. Higher scores indicate a worse outcome.
Time frame: Preoperatively
Sleep Quality
Assessed based on self-reported data collected using the Pittsburgh Sleep Quality Index (PSQI). Minimum Score: 0; Maximum Score: 21. Higher scores indicate a worse outcome.
Time frame: 6-week
Sleep Quality
Assessed based on self-reported data collected using the Pittsburgh Sleep Quality Index (PSQI). Minimum Score: 0; Maximum Score: 21. Higher scores indicate a worse outcome.
Time frame: 90 days
Sleep Quality
Assessed based on self-reported data collected using the Pittsburgh Sleep Quality Index (PSQI). Minimum Score: 0; Maximum Score: 21. Higher scores indicate a worse outcome.
Time frame: 1-year
Knee Function
Assessed based on self-reported data collected using the abbreviated Knee Injury and Osteoarthritis Outcome Score (KOOS Jr). Minimum Score: 0; Maximum Score: 28. Higher scores indicate a better outcome.
Time frame: Preoperatively, 6-week, 90-day and 1-year follow-up
Lower Extremity Activity
Assessed based on self-reported data collected using the Lower Extremity Activity Scale (LEAS). Minimum Score: 1; Maximum Score: 18. Higher scores indicate a better outcome.
Time frame: Preoperatively, 6-week, 90-day and 1-year follow-up
Overall Health
Assessed based on self-reported data collected using the Veterans Rand 12 (VR-12) Scale. Minimum Score: 0; Maximum Score: 100. Higher scores indicate a better outcome.
Time frame: Preoperatively, 6-week, 90-day and 1-year follow-up
Pain Ratings
Assessed based on self-reported data collected using the Visual Analogue Pain Scale. Minimum Score: 0; Maximum Score: 10. Higher scores indicate a worse outcome.
Time frame: Preoperatively, 6-week, 90-day and 1-year follow-up
Opioids Prescribed
This will me quantified in morphine milligram equivalents (MMEs). This information will be obtained for each patient using institutionally queried i-Stop data.
Time frame: 90-day follow-up
Quantity of Postoperative Centers for Medicare and Medicaid Services Complications
Assessed using institutional medical record data.
Time frame: 90-day follow-up
Study Medication Compliance
Assessed based on self-reported data collected via study survey.
Time frame: Weekly (Up to 6 weeks)
Quantity of Adverse Melatonin Medical Events
Assessed based on self-reported data collected via study survey.
Time frame: Weekly (Up to 6 weeks)
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