TKA Melatonin and Sleep Quality

Study Overview
=================
Brief 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.

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)

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

Conditions
-----------------
Arthroplasty, Replacement, Knee, Sleep Initiation and Maintenance Disorders

Intervention / Treatment
-----------------
* Dietary Supplement: Melatonin 5 mg
* Dietary Supplement: Placebo (Vitamin C)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin Group (Experimental)<br>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<br>* Participants will be taking one 5 mg tablet of Melatonin 30 minutes before bedtime nightly, for 6 weeks following their knee replacement surgeries.<br>|
| Sham Comparator: Placebo Group (Control)<br>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)<br>* Participants will be taking one placebo tablet 30 minutes before bedtime nightly, for 6 weeks following their knee replacement surgeries.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Assessed using institutional medical record data. | 90-day follow-up | 
| Study Medication Compliance | Assessed based on self-reported data collected via study survey. | Weekly (Up to 6 weeks) | 
| Quantity of Adverse Melatonin Medical Events | Assessed based on self-reported data collected via study survey. | Weekly (Up to 6 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melatonin, Arthroplasty, Knee, Sleep