ArthroplastyNCT05332717

TKA Melatonin and Sleep Quality

A study testing Melatonin 5 mg in people with Arthroplasty and Replacement, run by Hospital for Special Surgery, New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Arthroplasty, Replacement, Knee
What is being tested?: Melatonin 5 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 176 participants
Where: 1 siteUnited States
Study dates: 10 Jan 2022to 30 Apr 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital for Special Surgery
New York, New York, 10021

Other trials in United States

About this study

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

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.

Read the 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)

Conditions: Arthroplasty, Replacement, Knee, Sleep Initiation and Maintenance Disorders
Being tested: Melatonin 5 mg, Placebo (Vitamin C)
Keywords: Melatonin, Arthroplasty, Knee, Sleep
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Melatonin 5 mgDietary 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 (Vitamin C)Dietary supplement
Participants will be taking one placebo tablet 30 minutes before bedtime nightly, for 6 weeks following their knee replacement surgeries.

Study groups in NCT05332717
Study group	Role	What they receive
Melatonin Group (Experimental)	Experimental	Patients who will take one (1) 5mg Melatonin tablet 30 minutes before bedtime daily for the 6 weeks following surgery. Receives: 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. Receives: Dietary Supplement: Placebo (Vitamin C)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1-year

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90-day follow-up
Quantity of Postoperative Centers for Medicare and Medicaid Services Complications
Assessed using institutional medical record data.
Measured: 90-day follow-up
Study Medication Compliance
Assessed based on self-reported data collected via study survey.
Measured: Weekly (Up to 6 weeks)
Quantity of Adverse Melatonin Medical Events
Assessed based on self-reported data collected via study survey.
Measured: Weekly (Up to 6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 202230 Apr 2022

First posted18 Apr 2022
Study start10 Jan 2022
Primary completion31 Jan 2022
Study completion30 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for ArthroplastyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05332717
Sponsor's protocol ID: 2021-0150
Status last verified: Sep 2023
First submitted: 10 Aug 2021
Last updated: 14 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: IPD will not be made available at the study conclusion due to its inclusion of Protected Healthcare Information (PHI).

Publications

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.
PubMed 31481074
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.
PubMed 32900564
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.
PubMed 26173613
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.
PubMed 31752947
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.
PubMed 32415694
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.
PubMed 32532654

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Arthroplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Association Between Melatonin Use and Improved Sleep Quality After Total Knee Arthroplasty: A Randomized Control Trial
ClinicalTrials.gov ID: NCT05332717
Acronym / sponsor ID: 2021-0150
Conditions: Arthroplasty, Replacement, Knee, Sleep Initiation and Maintenance Disorders
Keywords: Melatonin, Arthroplasty, Knee, Sleep
Study type: Interventional
Recruitment status: Completed
Enrolment: 176 participants (actual)
Lead sponsor: Hospital for Special Surgery, New YorkUniversity, hospital or other
Study start: 10 Jan 2022 (actual)
Primary completion: 31 Jan 2022 (actual)
Study completion: 30 Apr 2022 (actual)
First posted: 18 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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)

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
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

Arm	Type	Receives
Melatonin Group (Experimental)	Experimental	Dietary Supplement: Melatonin 5 mgPatients who will take one (1) 5mg Melatonin tablet 30 minutes before bedtime daily for the 6 weeks following surgery.
Placebo Group (Control)	Sham comparator	Dietary Supplement: Placebo (Vitamin C)Patients who will take one (1) placebo (Vitamin C) tablet 30 minutes before bedtime daily for the 6 weeks following surgery.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Melatonin 5 mgParticipants will be taking one 5 mg tablet of Melatonin 30 minutes before bedtime nightly, for 6 weeks following their knee replacement surgeries.	Dietary supplement	Melatonin Group (Experimental)
Placebo (Vitamin C)Participants will be taking one placebo tablet 30 minutes before bedtime nightly, for 6 weeks following their knee replacement surgeries.	Dietary supplement	Placebo Group (Control)

Primary outcome

Sleep Quality
Time frame: Preoperatively
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.
Sleep Quality
Time frame: 6-week
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.
Sleep Quality
Time frame: 90 days
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.
Sleep Quality
Time frame: 1-year
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.

8 secondary outcomes

Knee Function
Time frame: Preoperatively, 6-week, 90-day and 1-year follow-up
Lower Extremity Activity
Time frame: Preoperatively, 6-week, 90-day and 1-year follow-up
Overall Health
Time frame: Preoperatively, 6-week, 90-day and 1-year follow-up
Pain Ratings
Time frame: Preoperatively, 6-week, 90-day and 1-year follow-up
Opioids Prescribed
Time frame: 90-day follow-up
Quantity of Postoperative Centers for Medicare and Medicaid Services Complications
Time frame: 90-day follow-up
Study Medication Compliance
Time frame: Weekly (Up to 6 weeks)
Quantity of Adverse Melatonin Medical Events
Time frame: Weekly (Up to 6 weeks)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
Background: PubMed 31481074Shakya 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.
Background: PubMed 32900564Mammoto 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.
Background: PubMed 26173613Kirksey 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.
Background: PubMed 31752947Luo 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.
Background: PubMed 32415694Hemati 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.
Background: PubMed 32532654Oh 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.
Individual participant dataSharing planned: No. IPD will not be made available at the study conclusion due to its inclusion of Protected Healthcare Information (PHI).

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alejandro G Della Valle, MD principal investigator

Hospital for Special Surgery, New York

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Melatonin 5 mg in people with Arthroplasty and Replacement, run by Hospital for Special Surgery, New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep Quality (time frame: Preoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05332717, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023; AzTrials last refreshed its copy on 28 Oct 2026.