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The primary purpose of this study was to determine if cannabinoid use decreases narcotic consumption in patients undergoing total knee arthroplasty (TKA).
Subjects enrolled will be randomized into one of two groups either receiving the study drug or a placebo and will be followed for the first 6 weeks with regards to outcomes data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dronabinol | Experimental | Patient will be directed to take 2.5mg of Study Drug 2 times a day for 4 weeks. Patient is blinded as to whether or not this is Dronabinol. |
|
| placebo | Placebo Comparator | Patient will be directed to take 2.5mg of Study Drug 2 times a day for 4 weeks. Patient is blinded as to whether or not this is Dronabinol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol | Drug | 2.5mg 2 times a day for 30 days after total knee replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Equivalence | Morphine Equivalence of pain medication used after a total knee replacement | 30 day's post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea | Patients post operative nausea will be collected as none/mild/moderate/severe | 30 day's post operative |
| Defense and Veterans Pain Scale | Patients will keep a pain log after their joint replacement on a scale of 0 - 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rose Johnson | Contact | 3032602940 | roseannjohnson@centura.org |
| Name | Affiliation | Role |
|---|---|---|
| Jason M Jennings, MD DPT | Colorado Joint Replacement | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Joint Replacement | Recruiting | Denver | Colorado | 80210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30799266 | Background | Hannon CP, Calkins TE, Li J, Culvern C, Darrith B, Nam D, Gerlinger TL, Buvanendran A, Della Valle CJ. The James A. Rand Young Investigator's Award: Large Opioid Prescriptions Are Unnecessary After Total Joint Arthroplasty: A Randomized Controlled Trial. J Arthroplasty. 2019 Jul;34(7S):S4-S10. doi: 10.1016/j.arth.2019.01.065. Epub 2019 Feb 4. | |
| 30794232 |
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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 |
|---|---|
| D013759 | Dronabinol |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo | Other | 2 times a day for 30 days after total knee replacement |
|
|
| 30 day's post operative |
| The Pittsburgh Sleep Quality Index | To monitor sleeping habits | 4 weeks and 6 weeks post operative |
| Knee Society Score | Patient reported outcome | 4 weeks post operative |
| KOOS-12 Knee Survey | Patient reported outcome | 6 weeks post operative |
| The Veterans Rand 12-Item Health Survey | Patient reported outcome | 6 weeks post operative |
| Jennings JM, Williams MA, Levy DL, Johnson RM, Eschen CL, Dennis DA. Has Self-reported Marijuana Use Changed in Patients Undergoing Total Joint Arthroplasty After the Legalization of Marijuana? Clin Orthop Relat Res. 2019 Jan;477(1):95-100. doi: 10.1097/CORR.0000000000000339. |
| 30170713 | Background | Hickernell TR, Lakra A, Berg A, Cooper HJ, Geller JA, Shah RP. Should Cannabinoids Be Added to Multimodal Pain Regimens After Total Hip and Knee Arthroplasty? J Arthroplasty. 2018 Dec;33(12):3637-3641. doi: 10.1016/j.arth.2018.07.027. Epub 2018 Aug 3. |
| 25156148 | Background | Hayes MJ, Brown MS. Legalization of medical marijuana and incidence of opioid mortality. JAMA Intern Med. 2014 Oct;174(10):1673-4. doi: 10.1001/jamainternmed.2014.2716. No abstract available. |
| 29257781 | Background | Heng M, McTague MF, Lucas RC, Harris MB, Vrahas MS, Weaver MJ. Patient Perceptions of the Use of Medical Marijuana in the Treatment of Pain After Musculoskeletal Trauma: A Survey of Patients at 2 Trauma Centers in Massachusetts. J Orthop Trauma. 2018 Jan;32(1):e25-e30. doi: 10.1097/BOT.0000000000001002. |
| 28796754 | Background | Khelemsky Y, Goldberg AT, Hurd YL, Winkel G, Ninh A, Qian L, Oprescu A, Ciccone J, Katz DJ. Perioperative Patient Beliefs Regarding Potential Effectiveness of Marijuana (Cannabinoids) for Treatment of Pain: A Prospective Population Survey. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):652-659. doi: 10.1097/AAP.0000000000000654. |
| 28097606 | Background | Chan MH, Knoepke CE, Cole ML, McKinnon J, Matlock DD. Colorado Medical Students' Attitudes and Beliefs About Marijuana. J Gen Intern Med. 2017 Apr;32(4):458-463. doi: 10.1007/s11606-016-3957-y. Epub 2017 Jan 17. |
| 28887020 | Background | Cancienne JM, Patel KJ, Browne JA, Werner BC. Narcotic Use and Total Knee Arthroplasty. J Arthroplasty. 2018 Jan;33(1):113-118. doi: 10.1016/j.arth.2017.08.006. Epub 2017 Aug 17. |
| 25694266 | Background | Menendez ME, Ring D, Bateman BT. Preoperative Opioid Misuse is Associated With Increased Morbidity and Mortality After Elective Orthopaedic Surgery. Clin Orthop Relat Res. 2015 Jul;473(7):2402-12. doi: 10.1007/s11999-015-4173-5. Epub 2015 Feb 19. |
| 25911660 | Background | Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163. |
| 15340387 | Background | Di Marzo V, Bifulco M, De Petrocellis L. The endocannabinoid system and its therapeutic exploitation. Nat Rev Drug Discov. 2004 Sep;3(9):771-84. doi: 10.1038/nrd1495. |
| 27832442 | Background | Fitzcharles MA, Hauser W. Cannabinoids in the Management of Musculoskeletal or Rheumatic Diseases. Curr Rheumatol Rep. 2016 Dec;18(12):76. doi: 10.1007/s11926-016-0625-5. |
| D012216 |
| Rheumatic Diseases |
| D004187 |
| Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |