TKA Melatonin and Sleep Quality

  • STATUS
    Recruiting
  • days left to enroll
    32
  • participants needed
    152
  • sponsor
    Hospital for Special Surgery, New York
Updated on 29 April 2022
melatonin
poor sleep
Accepts healthy volunteers

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.

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)

Details
Condition Arthroplasty, Replacement, Knee, Sleep Initiation and Maintenance Disorders
Treatment Melatonin 5 mg, Placebo (Vitamin C)
Clinical Study IdentifierNCT05332717
SponsorHospital for Special Surgery, New York
Last Modified on29 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients undergoing primary, unilateral TKA
Primary diagnosis of osteoarthritis (OA)
Aged 18+
Subject is opioid naive (has not taken opioids during the 6 months prior to surgery)
Subject is not currently taking sleep medication
English speaking
Has working email (for survey purposes)

Exclusion Criteria

Patients with diagnosis other than OA including: Inflammatory arthritis; Post-traumatic OA; Chronic pain; Insomnia _; Depression_ ; Anxiety; Any active sleep disorder
Planned contralateral knee or subsequent total joint arthroplasty within 90 days
Any planned surgery within 90 days
Patient taking medication for depression or insomnia or anxiety during the 6 months prior to surgery
Patients with renal or hepatic disorders as these can affect melatonin metabolism
Insomnia, anxiety, and depression will be defined as use of controlled medication for that disorder which will be identified in istop or HSS record of the patient filled in the 6 months prior to surgery
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