Treatment for Osteoarthritis of the Knee

Phase-Based Estimates
1
Effectiveness
1
Safety
NYU Langone Health, New York, NY
+2 More
Eligibility
18+
All Sexes
Eligible conditions
Osteoarthritis of the Knee

Study Summary

Melatonin Use After Primary Total Joint Arthroplasty

See full description

Eligible Conditions

  • Arthrosis
  • Osteoarthritis, Knee
  • Osteoarthritis of the Knee
  • Osteoarthritis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes and 2 secondary outcomes in patients with Osteoarthritis of the Knee. Measurement will happen over the course of Visit 1 (Screening Visit), 14 days after surgery visit.

Day 14
Change in narcotic consumption patterns
Change in quality of hospital length of stay
Month 2
Change in Sleep Disturbance
Change in the quality of sleep

Trial Safety

Safety Estimate

1 of 3

Trial Design

4 Treatment Groups

Knee cohort
Placebo group

This trial requires 252 total participants across 4 different treatment groups

This trial involves 4 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Knee cohort
Drug
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
Hip cohort control
Other
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
Knee cohort control
Other
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
Hip cohort
Drug
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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: visit 1 (screening visit), visit 2 (2 months post surgery)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly visit 1 (screening visit), visit 2 (2 months post surgery) for reporting.

Closest Location

NYU Langone Health - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

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Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Osteoarthritis of the Knee by sharing your contact details with the study coordinator.