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Taking people in United StatesPhase 4

Magnesium-L-Threonate for Sleep After Joint Replacement Surgery

Tests Magnesium-L-Threonate for sleep and pain after total joint replacement surgery.

Key facts

Who runs it
University of Miami
Where
Miami, United StatesSee the site
Trial code
Registry title
Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty
Status
Recruiting
Phase
Phase 4
People taking part
64 people, planned
Started
21 Apr 2025
Expected to end
1 Jul 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Magnesium Threonate
  • Control
Record updated
9 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults having a first total knee or hip replacement at the University of Miami Hospital. It tests whether Magnesium-L-Threonate improves sleep and reduces pain after surgery.

Age
Over 18 years.
Sex
All sexes can join.
Disease stage
Primary osteoarthritis (joint wear) needing a first total knee or hip replacement.
Earlier treatment
People who already had a joint replacement at the same site cannot join.

Main reasons for not taking part

  • Sleep disorders such as narcolepsy, sleep apnea, insomnia, parasomnias or restless leg syndrome
  • Psychiatric disorders that could affect sleep, or medicines that cause strong sleepiness or insomnia
  • Pregnant or breastfeeding
  • Liver failure (INR greater than 1.5 or Prothrombin time greater than 40) or kidney disease (glomerular filtration rate less than 30 mL/min)
  • Substance use disorder within 6 months of surgery, or surgery for a reason other than primary osteoarthritis, such as a fracture

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Previous total joint arthroplasty at the surgical site
  • Participants taking medications known to cause significant sedation or insomnia
  • 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
  • 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
  • Pregnant or breastfeeding
  • Being treated for a diagnosis other than primary osteoarthritis (e.g. pelvic/femur fracture)

Where in United States

  • University of Miami HospitalMiami, United StatesContact: Natalia Cruz, MDTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Magnesium L Threonate GroupTreatment being tested

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

    Treatment: Magnesium Threonate

  • Control GroupPlacebo, for comparison

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

    Treatment: Control

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Use of Magnesium-L-Threonate to Improve Subjective Sleep Quality After Total Joint Arthroplasties: Randomized Controlled Clinical Trial
Plain-language title
Magnesium-L-Threonate for Sleep After Joint Replacement SurgeryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
9 July 2026