TKA Melatonin and Sleep Quality

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2022-04-30

Brief Summary

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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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Detailed Description

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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)

Conditions

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Arthroplasty Replacement Knee Sleep Initiation and Maintenance Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will compare postoperative sleep quality in two groups of patients undergoing primary total knee arthroplasty (TKA):

* Group 1 will take melatonin during the 6 week postoperative period
* Group 2 will take a placebo during the 6 week postoperative period

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Participants will not be informed if they are receiving study drugs or placebo pills.

Placebos will be compounded to be identical to treatment drugs in shape, size, color, texture etc.

Study Groups

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Melatonin Group (Experimental)

Patients who will take one (1) 5mg Melatonin tablet 30 minutes before bedtime daily for the 6 weeks following surgery.

Group Type EXPERIMENTAL

Melatonin 5 mg

Intervention Type 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 Group (Control)

Patients who will take one (1) placebo (Vitamin C) tablet 30 minutes before bedtime daily for the 6 weeks following surgery.

Group Type SHAM_COMPARATOR

Placebo (Vitamin C)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes