TKA Melatonin and Sleep Quality

NCT05332717 | Completed

• 1 other identifier: 2021-0150
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty; Replacement; Knee; Sleep Initiation and Maintenance Disorders

Keywords

Melatonin; Arthroplasty; Knee; Sleep

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Knee Function

  Preoperatively, 6-week, 90-day and 1-year follow-up

• Lower Extremity Activity

  Preoperatively, 6-week, 90-day and 1-year follow-up

• Overall Health

  Preoperatively, 6-week, 90-day and 1-year follow-up

• Pain Ratings

  Preoperatively, 6-week, 90-day and 1-year follow-up

• Opioids Prescribed

  90-day follow-up

Study Arms (2)

Melatonin Group (Experimental)

EXPERIMENTAL

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

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.

Dietary Supplement: Placebo (Vitamin C)

Interventions

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.

Melatonin Group (Experimental)

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.

Placebo Group (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (6)

• 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.

  PMID: 31481074 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.

  PMID: 32900564 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.

  PMID: 26173613 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.

  PMID: 31752947 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.

  PMID: 32415694 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.

  PMID: 32532654 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Melatonin; Ascorbic Acid

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Alejandro G Della Valle, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: April 18, 2022
• Study Start: January 10, 2022
• Primary Completion: January 31, 2022
• Study Completion: April 30, 2022
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)