Knee Osteoarthritis, Sleep
Conditions
Brief summary
The study team is conducting a study to see if Magnesium-L-Threonate (MgT) can help improve how well participants sleep and reduce pain after total joint replacement surgery
Interventions
Participants will receive a daily 145 mg pill by mouth 30 minutes before going to sleep
OTHERControl
Participants will receive two sugar pills daily by mouth 30 minutes before going to sleep
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing primary total knee or hip arthroplasty at the University of Miami Hospital * Patients \> 18 years of age * Subjects must be capable of providing informed consent * English or Spanish-speaking
Exclusion criteria
* Previous total joint arthroplasty at the surgical site * History of sleeping disorders, including narcolepsy, sleep apnea, insomnia, parasomnias, and restless leg syndrome. * History of Complex Regional Pain Syndrome in ipsilateral extremity * History of demyelinating disorder or neurologic deficit in the affected extremity * History of psychiatric disorders that could impact sleep, such as untreated depression, bipolar disorder, or schizophrenia. * Participants taking medications known to cause significant sedation or insomnia. * Pregnant or breastfeeding * Being treated for a diagnosis other than primary osteoarthritis (e.g. pelvic/femur fracture) * Patients with known substance use disorder within 6 months of surgery * Liver Failure, via clinical diagnosis or international normalized ratio greater than 1.5 or Prothrombin time greater than 40 * Chronic Kidney Disease or glomerular filtration rate less than 30 mL/min
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Epsworth Sleepiness Score | 2 weeks, 4 weeks, 6 weeks | Score ranging from 0-24 with higher scores indicating greater sleepiness. |
| Change in Pittsburgh Sleep Quality Index (PSQI) | 2 weeks, 4 weeks, 6 weeks | The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is \>5 indicates "poor sleep |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Morphine Milligram Equivalent Prescribed | 2 weeks, 4 weeks, 6 weeks | Measured in milligram equivalents |
| Patient-reported outcome measured by Knee Injury and Osteoarthritis Outcome Score | 6 weeks | The total score ranges from 0-100. Lowers scores indicate a healthier knee |
| Medication Compliance measured in number of days study medication taken | 6 weeks | Medication compliance as measured by number of days taking study medication |
Countries
United States
Contacts
CONTACTVictor H Hernandez, MD
CONTACTJonathan Stern, MD
PRINCIPAL_INVESTIGATORVictor H Hernandez, MD
University of Miami
Outcome results
None listed