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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. completion2026-07-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Interventions1

Locations1 site

University of Miami Hospital
Miami, Florida, 33136
Natalia Cruz, MD

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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