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):
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:
Condition | Arthroplasty, Replacement, Knee, Sleep Initiation and Maintenance Disorders |
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Treatment | Melatonin 5 mg, Placebo (Vitamin C) |
Clinical Study Identifier | NCT05332717 |
Sponsor | Hospital for Special Surgery, New York |
Last Modified on | 7 October 2022 |
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