Melatonin Use After Primary Total Joint Arthroplasty

NYU Langone Health

Status and phase: Completed; Phase 1

Conditions: Osteo Arthritis Knee

Treatments: Other: Placebo; Drug: Melatonin 5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04795336

20-02030

Details and patient eligibility

About

The purpose of this study is to determine the effect of melatonin supplementation on patient sleep quality, length of stay, and opioid consumption following primary, unilateral, elective total hip or knee arthroplasty.

Full description

This will be a single-center randomized double blind placebo control clinical trial. In the cohort of patients undergoing primary elective total hip and the cohort of patients undergoing primary elective knee arthroplasty, participants are recruited from those who are willing to consent and participate in the study, and will be randomly 1:1 divided into intervention group and placebo group.

Enrollment: 294 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient are current candidates for elective primary total hip and total knee arthroplasty.
• Patients ≥18 years of age but ≤ 95
• Patients have been medically cleared and scheduled for surgery

Exclusion criteria

• Non-elective conversion arthroplasty
• Bilateral total joint arthroplasty
• Contraindications to use of melatonin (diabetes, calcium channel blocker use, depression)
• Conditions and medications likely to confound results due to impact on subjective and/or objective sleep quality (insomnia, drug/alcohol abuse, and use of benzodiazepines, and prescription sleep aids)
• Conditions likely to impair capacity to adhere to protocol (mental impairment, psychiatric disorders other than anxiety/depression)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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294 participants in 4 patient groups, including a placebo group

Knee cohort

Active Comparator group

Description:

In the cohort of patients undergoing primary elective knee arthroplasty, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days

Treatment:

Drug: Melatonin 5 mg

Knee cohort control

Placebo Comparator group

Description:

In the cohort of patients undergoing primary elective knee arthroplasty, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into placebo group. Control group will receive a placebo pill for 14 days

Treatment:

Other: Placebo

Hip cohort

Active Comparator group

Description:

In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days

Treatment:

Drug: Melatonin 5 mg

Hip cohort control

Placebo Comparator group

Description:

In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into placebo group. Control group will receive a placebo pill for 14 days

Treatment:

Other: Placebo