Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty

University of Miami

Status and phase: Enrolling; Phase 4

Conditions: Knee Osteoarthritis; Sleep

Treatments: Other: Control; Drug: Magnesium Threonate

Study type: Interventional

Funder types: Other

Identifiers

NCT06902285

20240578

Details and patient eligibility

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

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

Magnesium L Threonate Group

Experimental group

Description:

Participants in this group will receive the Magnesium L Threonate intervention for up to 6 weeks postoperatively

Treatment:

Drug: Magnesium Threonate

Control Group

Placebo Comparator group

Description:

Participants in this group will receive the placebo comparator for up to 6 weeks postoperatively

Treatment:

Other: Control