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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.
This study will compare postoperative sleep quality in two groups of patients undergoing primary total knee arthroplasty (TKA):
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin Group (Experimental) | Experimental | Patients who will take one (1) 5mg Melatonin tablet 30 minutes before bedtime daily for the 6 weeks following surgery. |
|
| Placebo Group (Control) | Sham Comparator | Patients who will take one (1) placebo (Vitamin C) tablet 30 minutes before bedtime daily for the 6 weeks following surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Alejandro G Della Valle, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31481074 | Background | Shakya H, Wang D, Zhou K, Luo ZY, Dahal S, Zhou ZK. Prospective randomized controlled study on improving sleep quality and impact of zolpidem after total hip arthroplasty. J Orthop Surg Res. 2019 Sep 3;14(1):289. doi: 10.1186/s13018-019-1327-2. | |
| 32900564 | Background | Mammoto T, Fujie K, Taguchi N, Ma E, Shimizu T, Hashimoto K. Short-Term Effects of Early Postoperative Celecoxib Administration for Pain, Sleep Quality, and Range of Motion After Total Knee Arthroplasty: A Randomized Controlled Trial. J Arthroplasty. 2021 Feb;36(2):526-531. doi: 10.1016/j.arth.2020.08.018. Epub 2020 Aug 18. |
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IPD will not be made available at the study conclusion due to its inclusion of Protected Healthcare Information (PHI).
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 10, 2022 | Apr 11, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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This study will compare postoperative sleep quality in two groups of patients undergoing primary total knee arthroplasty (TKA):
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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.
| 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. |
|
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) |
| 26173613 | Background | 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. |
| 31752947 | Background | 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. |
| 32415694 | Background | Hemati K, Pourhanifeh MH, Dehdashtian E, Fatemi I, Mehrzadi S, Reiter RJ, Hosseinzadeh A. Melatonin and morphine: potential beneficial effects of co-use. Fundam Clin Pharmacol. 2021 Feb;35(1):25-39. doi: 10.1111/fcp.12566. Epub 2020 Jun 21. |
| 32532654 | Background | Oh ES, Leoutsakos JM, Rosenberg PB, Pletnikova AM, Khanuja HS, Sterling RS, Oni JK, Sieber FE, Fedarko NS, Akhlaghi N, Neufeld KJ. Effects of Ramelteon on the Prevention of Postoperative Delirium in Older Patients Undergoing Orthopedic Surgery: The RECOVER Randomized Controlled Trial. Am J Geriatr Psychiatry. 2021 Jan;29(1):90-100. doi: 10.1016/j.jagp.2020.05.006. Epub 2020 May 16. |
| D001523 |
| Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |