Status:
COMPLETED
TKA Melatonin and Sleep Quality
Lead Sponsor:
Hospital for Special Surgery, New York
Conditions:
Arthroplasty
Replacement
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 b...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
January 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT05332717
Start Date
January 10 2022
End Date
April 30 2022
Last Update
September 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital for Special Surgery
New York, New York, United States, 10021