Clinical trial NCT05332717: TKA Melatonin and Sleep Quality
Official title: Association Between Melatonin Use and Improved Sleep Quality After Total Knee Arthroplasty: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty
Replacement
Knee
Sleep Initiation and Maintenance Disorders
Keywords: Melatonin
Arthroplasty
Knee
Sleep
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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)

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

Primary outcomes:
measure: Sleep Quality
timeFrame: Preoperatively
measure: Sleep Quality
timeFrame: 6-week
measure: Sleep Quality
timeFrame: 90 days
measure: Sleep Quality
timeFrame: 1-year
Secondary outcomes:
measure: Knee Function
timeFrame: Preoperatively, 6-week, 90-day and 1-year follow-up
measure: Lower Extremity Activity
timeFrame: Preoperatively, 6-week, 90-day and 1-year follow-up
measure: Overall Health
timeFrame: Preoperatively, 6-week, 90-day and 1-year follow-up
measure: Pain Ratings
timeFrame: Preoperatively, 6-week, 90-day and 1-year follow-up
measure: Opioids Prescribed
timeFrame: 90-day follow-up
measure: Quantity of Postoperative Centers for Medicare and Medicaid Services Complications
timeFrame: 90-day follow-up
measure: Study Medication Compliance
timeFrame: Weekly (Up to 6 weeks)
measure: Quantity of Adverse Melatonin Medical Events
timeFrame: Weekly (Up to 6 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Alejandro G Della Valle, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kirksey MA, Yoo D, Danninger T, Stundner O, Ma Y, Memtsoudis SG. Impact of Melatonin on Sleep and Pain After Total Knee Arthroplasty Under Regional Anesthesia With Sedation: A Double-Blind, Randomized, Placebo-Controlled Pilot Study. J Arthroplasty. 2015 Dec;30(12):2370-5. doi: 10.1016/j.arth.2015.06.034. Epub 2015 Jun 21.
citation: Luo ZY, Li LL, Wang D, Wang HY, Pei FX, Zhou ZK. Preoperative sleep quality affects postoperative pain and function after total joint arthroplasty: a prospective cohort study. J Orthop Surg Res. 2019 Nov 21;14(1):378. doi: 10.1186/s13018-019-1446-9.
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