Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty
Recruiting · NCT06902285 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Miami
View the official record on ClinicalTrials.gov →Interventions studied
ControlMagnesium Threonate
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- University of Miami Hospital - Miami, Florida, United States