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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

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Conditions

SleepKnee Osteoarthritis

Locations

University of Miami Hospital

Miami, Florida 33136

United States