TKA Melatonin and Sleep Quality

Sleep Initiation and Maintenance Disorders Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

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

• NCT number: NCT05332717
• Study type: Interventional
• Source: Hospital for Special Surgery, New York
• Status: Completed
• Phase: N/A
• Start date: January 10, 2022
• Completion date: April 30, 2022