NCT05332717

TKA Melatonin and Sleep Quality

Association Between Melatonin Use and Improved Sleep Quality After Total Knee Arthroplasty: A Randomized Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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)

Conditions

• Arthroplasty
• Replacement
• Knee
• Sleep Initiation and Maintenance Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Melatonin 5 mg	Participants will be taking one 5 mg tablet of Melatonin 30 minutes before bedtime nightly, for 6 weeks following their knee replacement surgeries.
DIETARY_SUPPLEMENT	Placebo (Vitamin C)	Participants will be taking one placebo tablet 30 minutes before bedtime nightly, for 6 weeks following their knee replacement surgeries.

Timeline

• Start date: 2022-01-10
• Primary completion: 2022-01-31
• Completion: 2022-04-30
• First posted: 2022-04-18
• Last updated: 2023-09-14

Locations

1 site across 1 country: United States