Using Magnesium-L-Threonate to Improve Sleep After Joint Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of Magnesium-L-Threonate (MgT) on sleep quality and pain reduction in patients who have undergone total knee or hip arthroplasty. Participants will be randomly assigned to receive either MgT or a control treatment. The study aims to determine if MgT can enhance sleep quality post-surgery, which is crucial for recovery and overall well-being. The research is being conducted at the University of Miami Hospital, focusing on patients who are 18 years or older and can provide informed consent.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Miami Hospital
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Victor H Hernandez, MD — University of Miami
• Study coordinator: Victor H Hernandez, MD
• Email: vhh1@miami.edu
• Phone: 305-689-5195

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.