NCT06902285PHASE4Recruiting
Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty
University of Miami
Start Date
4/21/2025
Completion Date
7/1/2027
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
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
DRUG
Magnesium Threonate
OTHER
Control
Conditions
SleepKnee Osteoarthritis
Locations
University of Miami Hospital
Miami, Florida 33136
United States