Status:
RECRUITING
Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty
Lead Sponsor:
University of Miami
Conditions:
Sleep
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06902285
Start Date
April 21 2025
End Date
May 1 2026
Last Update
April 24 2025
Active Locations (1)
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1
University of Miami Hospital
Miami, Florida, United States, 33136