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Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty
RECRUITINGPhase 4Sponsored by University of Miami
Actively Recruiting
PhasePhase 4
SponsorUniversity of Miami
Started2025-04-21
Est. completion2026-05-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06902285
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions3
ArthritisKnee OsteoarthritisSleep
Locations1 site
University of Miami Hospital
Miami, Florida, 33136
Natalia Cruz, MD
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Actively Recruiting
PhasePhase 4
SponsorUniversity of Miami
Started2025-04-21
Est. completion2026-05-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06902285