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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium L Threonate Group | Experimental | Participants in this group will receive the Magnesium L Threonate intervention for up to 6 weeks postoperatively |
|
| Control Group | Placebo Comparator | Participants in this group will receive the placebo comparator for up to 6 weeks postoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Threonate | Drug | Participants will receive a daily 145 mg pill by mouth 30 minutes before going to sleep |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Epsworth Sleepiness Score | Score ranging from 0-24 with higher scores indicating greater sleepiness. | 2 weeks, 4 weeks, 6 weeks |
| Change in Pittsburgh Sleep Quality Index (PSQI) | 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 | 2 weeks, 4 weeks, 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Morphine Milligram Equivalent Prescribed | Measured in milligram equivalents | 2 weeks, 4 weeks, 6 weeks |
| Patient-reported outcome measured by Knee Injury and Osteoarthritis Outcome Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victor H Hernandez, MD | Contact | 305-689-5195 | vhh1@miami.edu | |
| Jonathan Stern, MD | Contact | 305-689-5195 | jms188@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Victor H Hernandez, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Hospital | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C011369 | threonic acid |
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| Control | Other | Participants will receive two sugar pills daily by mouth 30 minutes before going to sleep |
|
The total score ranges from 0-100. Lowers scores indicate a healthier knee
| 6 weeks |
| Medication Compliance measured in number of days study medication taken | Medication compliance as measured by number of days taking study medication | 6 weeks |
| D012216 |
| Rheumatic Diseases |