Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty
Purpose
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
Conditions
- Sleep
- Knee Osteoarthritis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Magnesium L Threonate Group |
Participants in this group will receive the Magnesium L Threonate intervention for up to 6 weeks postoperatively |
|
|
Placebo Comparator Control Group |
Participants in this group will receive the placebo comparator for up to 6 weeks postoperatively |
|
Recruiting Locations
University of Miami Hospital
Miami, Florida 33136
Miami, Florida 33136
Contact:
Natalia Cruz, MD
Natalia Cruz, MD
More Details
- NCT ID
- NCT06902285
- Status
- Recruiting
- Sponsor
- University of Miami