Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty

Phase 4

Recruiting

• Conditions: Sleep; Knee Osteoarthritis
• Interventions: Drug: Magnesium Threonate; Other: Control

• Registration Number: NCT06902285
• Lead Sponsor: University of Miami

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Study First Posted: 2025-03-30
• Status Verified: 2025-04
• Study Start: 2025-04-21
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium L Threonate Group	Magnesium Threonate	Participants in this group will receive the Magnesium L Threonate intervention for up to 6 weeks postoperatively
Control Group	Control	Participants in this group will receive the placebo comparator for up to 6 weeks postoperatively

Primary Outcome Measures

Name	Time	Method
Change in Pittsburgh Sleep Quality Index (PSQI)	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
Change in Epsworth Sleepiness Score	2 weeks, 4 weeks, 6 weeks	Score ranging from 0-24 with higher scores indicating greater sleepiness.

Secondary Outcome Measures

Name	Time	Method
Patient-reported outcome measured by Knee Injury and Osteoarthritis Outcome Score	6 weeks	The total score ranges from 0-100. Lowers scores indicate a healthier knee
Medication Compliance measured in number of days study medication taken	6 weeks	Medication compliance as measured by number of days taking study medication
Change in Morphine Milligram Equivalent Prescribed	2 weeks, 4 weeks, 6 weeks	Measured in milligram equivalents

Trial Locations

Locations (1)

University of Miami Hospital; 🇺🇸 Miami, Florida, United States