Status:
COMPLETED
Melatonin Use After Primary Total Joint Arthroplasty
Lead Sponsor:
NYU Langone Health
Conditions:
Osteo Arthritis Knee
Eligibility:
All Genders
18-95 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed 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 elect...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2024
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT04795336
Start Date
July 12 2021
End Date
April 18 2024
Last Update
May 4 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016