RECRUITING

Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty

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Conditions

SleepKnee Osteoarthritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-04-21
Study Completion:2026-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06902285

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients undergoing primary total knee or hip arthroplasty at the University of Miami Hospital
  2. * Patients \> 18 years of age
  3. * Subjects must be capable of providing informed consent
  4. * English or Spanish-speaking
  1. * Previous total joint arthroplasty at the surgical site
  2. * History of sleeping disorders, including narcolepsy, sleep apnea, insomnia, parasomnias, and restless leg syndrome.
  3. * History of Complex Regional Pain Syndrome in ipsilateral extremity
  4. * History of demyelinating disorder or neurologic deficit in the affected extremity
  5. * History of psychiatric disorders that could impact sleep, such as untreated depression, bipolar disorder, or schizophrenia.
  6. * Participants taking medications known to cause significant sedation or insomnia.
  7. * Pregnant or breastfeeding
  8. * Being treated for a diagnosis other than primary osteoarthritis (e.g. pelvic/femur fracture)
  9. * Patients with known substance use disorder within 6 months of surgery
  10. * Liver Failure, via clinical diagnosis or international normalized ratio greater than 1.5 or Prothrombin time greater than 40
  11. * Chronic Kidney Disease or glomerular filtration rate less than 30 mL/min

Contacts and Locations

Study Contact

Victor H Hernandez, MD
CONTACT
305-689-5195
vhh1@miami.edu
Jonathan Stern, MD
CONTACT
305-689-5195
jms188@miami.edu

Principal Investigator

Victor H Hernandez, MD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami Hospital
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Victor H Hernandez, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-21
Study Completion Date2026-05-01

Study Record Updates

Study Start Date2025-04-21
Study Completion Date2026-05-01

Terms related to this study

Additional Relevant MeSH Terms

  • Sleep
  • Knee Osteoarthritis