TKA Melatonin and Sleep Quality

September 12, 2023 updated by: Hospital for Special Surgery, New York

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital For Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin Group (Experimental)
Patients who will take one (1) 5mg Melatonin tablet 30 minutes before bedtime daily for the 6 weeks following surgery.
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.
Sham Comparator: Placebo Group (Control)
Patients who will take one (1) placebo (Vitamin C) tablet 30 minutes before bedtime daily for the 6 weeks following surgery.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality
Time Frame: Preoperatively
Assessed based on self-reported data collected using the Pittsburgh Sleep Quality Index (PSQI). Minimum Score: 0; Maximum Score: 21. Higher scores indicate a worse outcome.
Preoperatively
Sleep Quality
Time Frame: 6-week
Assessed based on self-reported data collected using the Pittsburgh Sleep Quality Index (PSQI). Minimum Score: 0; Maximum Score: 21. Higher scores indicate a worse outcome.
6-week
Sleep Quality
Time Frame: 90 days
Assessed based on self-reported data collected using the Pittsburgh Sleep Quality Index (PSQI). Minimum Score: 0; Maximum Score: 21. Higher scores indicate a worse outcome.
90 days
Sleep Quality
Time Frame: 1-year
Assessed based on self-reported data collected using the Pittsburgh Sleep Quality Index (PSQI). Minimum Score: 0; Maximum Score: 21. Higher scores indicate a worse outcome.
1-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Function
Time Frame: Preoperatively, 6-week, 90-day and 1-year follow-up
Assessed based on self-reported data collected using the abbreviated Knee Injury and Osteoarthritis Outcome Score (KOOS Jr). Minimum Score: 0; Maximum Score: 28. Higher scores indicate a better outcome.
Preoperatively, 6-week, 90-day and 1-year follow-up
Lower Extremity Activity
Time Frame: Preoperatively, 6-week, 90-day and 1-year follow-up
Assessed based on self-reported data collected using the Lower Extremity Activity Scale (LEAS). Minimum Score: 1; Maximum Score: 18. Higher scores indicate a better outcome.
Preoperatively, 6-week, 90-day and 1-year follow-up
Overall Health
Time Frame: Preoperatively, 6-week, 90-day and 1-year follow-up
Assessed based on self-reported data collected using the Veterans Rand 12 (VR-12) Scale. Minimum Score: 0; Maximum Score: 100. Higher scores indicate a better outcome.
Preoperatively, 6-week, 90-day and 1-year follow-up
Pain Ratings
Time Frame: Preoperatively, 6-week, 90-day and 1-year follow-up
Assessed based on self-reported data collected using the Visual Analogue Pain Scale. Minimum Score: 0; Maximum Score: 10. Higher scores indicate a worse outcome.
Preoperatively, 6-week, 90-day and 1-year follow-up
Opioids Prescribed
Time Frame: 90-day follow-up
This will me quantified in morphine milligram equivalents (MMEs). This information will be obtained for each patient using institutionally queried i-Stop data.
90-day follow-up
Quantity of Postoperative Centers for Medicare and Medicaid Services Complications
Time Frame: 90-day follow-up
Assessed using institutional medical record data.
90-day follow-up
Study Medication Compliance
Time Frame: Weekly (Up to 6 weeks)
Assessed based on self-reported data collected via study survey.
Weekly (Up to 6 weeks)
Quantity of Adverse Melatonin Medical Events
Time Frame: Weekly (Up to 6 weeks)
Assessed based on self-reported data collected via study survey.
Weekly (Up to 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Investigators

  • Principal Investigator: Alejandro G Della Valle, MD, Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2022

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 18, 2022

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0150

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be made available at the study conclusion due to its inclusion of Protected Healthcare Information (PHI).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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