TKA Melatonin & Sleep Quality

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) ;

Study Design

Related Conditions & MeSH terms

Arthroplasty
Knee
Replacement
Sleep Initiation and Maintenance Disorders

Clinical Trial Details

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

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

TKA Melatonin and Sleep Quality

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms