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NCT Number: NCT06902285

Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami Hospital

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Colin McNamara, MD

SUB_INVESTIGATOR

Jonathan Stern, MD

SUB_INVESTIGATOR

Natalia Cruz, MD

CONTACT

Natalia Cruz, MD

SUB_INVESTIGATOR

Victor H Hernandez, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium Threonate

Drug

Participants will receive a daily 145 mg pill by mouth 30 minutes before going to sleep

Control

Other

Participants will receive two sugar pills daily by mouth 30 minutes before going to sleep

Primary outcomes

  1. Change in Epsworth Sleepiness Score

    Time frame: 2 weeks, 4 weeks, 6 weeks

    Score ranging from 0-24 with higher scores indicating greater sleepiness.

  2. Change in Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 2 weeks, 4 weeks, 6 weeks

    The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is >5 indicates "poor sleep

Secondary outcomes

  1. Change in Morphine Milligram Equivalent Prescribed

    Time frame: 2 weeks, 4 weeks, 6 weeks

    Measured in milligram equivalents

  2. Patient-reported outcome measured by Knee Injury and Osteoarthritis Outcome Score

    Time frame: 6 weeks

    The total score ranges from 0-100. Lowers scores indicate a healthier knee

  3. Medication Compliance measured in number of days study medication taken

    Time frame: 6 weeks

    Medication compliance as measured by number of days taking study medication

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Stern, MD

CONTACT

[email protected]

305-689-5195

Victor H Hernandez, MD

CONTACT

[email protected]

305-689-5195

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Use of Magnesium-L-Threonate to Improve Subjective Sleep Quality After Total Joint Arthroplasties: Randomized Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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