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Completed

NCT Number: NCT05332717

TKA Melatonin and Sleep Quality

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.

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Key information

Conditions

Arthroplasty Dyssomnias Knee Mental Disorders Nervous System Diseases Replacement Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin 5 mg

Dietary Supplement

Participants will be taking one 5 mg tablet of Melatonin 30 minutes before bedtime nightly, for 6 weeks following their knee replacement surgeries.

Placebo (Vitamin C)

Dietary Supplement

Participants will be taking one placebo tablet 30 minutes before bedtime nightly, for 6 weeks following their knee replacement surgeries.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Quantity of Postoperative Centers for Medicare and Medicaid Services Complications

    Time frame: 90-day follow-up

    Assessed using institutional medical record data.

  7. Study Medication Compliance

    Time frame: Weekly (Up to 6 weeks)

    Assessed based on self-reported data collected via study survey.

  8. Quantity of Adverse Melatonin Medical Events

    Time frame: Weekly (Up to 6 weeks)

    Assessed based on self-reported data collected via study survey.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2022
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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