Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty

Last updated: April 21, 2025
Sponsor: University of Miami
Overall Status: Active - Recruiting

Phase

4

Condition

Knee Injuries

Osteoarthritis

Treatment

Magnesium Threonate

Control

Clinical Study ID

NCT06902285
20240578
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patients undergoing primary total knee or hip arthroplasty at the University ofMiami Hospital

  • Patients > 18 years of age

  • Subjects must be capable of providing informed consent

  • English or Spanish-speaking

Exclusion

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 untreateddepression, 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/femurfracture)

  • 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

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: Magnesium Threonate
Phase: 4
Study Start date:
April 21, 2025
Estimated Completion Date:
May 01, 2026

Connect with a study center

  • University of Miami Hospital

    Miami, Florida 33136
    United States

    Active - Recruiting

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