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Pain control and early range of motion following total knee arthroplasty are essential for patient satisfaction. Intraoperative steroids (dexamethasone) have been shown to have a significant effect in controlling acute pain following total knee arthroplasty. This study aims to evaluate the effect of a post-operative steroid (methylprednisolone) taper in improving functional and patient-reported outcomes following total knee arthroplasty. A taper means taking a high dose of a medication followed by taking lower doses and each following day until the medication is stopped.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative and Post-operative steroid | Experimental | Patients in this groups will receive intraoperative intravenous dexamethasone as well as a 6-day post-operative methylprednisolone taper |
|
| Intraoperative Steroid | Active Comparator | Patients randomized to this group will only receive intraoperative intravenous dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone 4 milligram Tab | Drug | 6-day 4 milligram methylprednisolone oral taper |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily Pain at rest and with movement | numeric rating scale from 0 to 10 (0=minimal, 10=maximal) will be used to capture patient experienced pain | daily for two weeks |
| Prescription narcotic usage | Oral morphine equivalent units will be collected based on patient usage of prescribed narcotic pain medication | daily for two weeks |
| Sleep disturbance | Patients will be asked if pain caused them to be awoken in the night and if so what level of pain they were experiencing at that time | daily for two weeks |
| Knee Range of motion | goniometric measurement of knee extension and flexion | 2-week, 6-week and 3-month postoperative visits |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing | Surgical site will be evaluated for normal wound healing | 2-week, 6-week and 3-month postoperative visits |
| Knee Injury and Osteoarthritis Outcome Scores | Questionnaire assessing for function will be administered (0= extreme problems present, 100= no problems present) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | All complications related to the patients procedure including infection, need for revision, emergency room visits, readmissions, etc. will be collected | To occur at 30 and 90 days postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes F Plate | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC East | Monroeville | Pennsylvania | 15146 | United States | ||
| UPMC Shadyside Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38316236 | Background | Wagner ER, Hussain ZB, Karzon AL, Cooke HL, Toston RJ, Hurt JT, Dawes AM, Gottschalk MB. Methylprednisolone taper is an effective addition to multimodal pain regimens after total shoulder arthroplasty: results of a randomized controlled trial: 2022 Neer Award winner. J Shoulder Elbow Surg. 2024 May;33(5):985-993. doi: 10.1016/j.jse.2023.12.016. Epub 2024 Feb 4. | |
| 36058564 |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Dexamethasone injection | Drug | 4 milligram intravenous dexamethasone will be administered intraoperatively |
|
| 2-week, 6-week and 3-month postoperative visits |
| Pittsburgh |
| Pennsylvania |
| 15232 |
| United States |
| Gottschalk MB, Dawes A, Hurt J, Spencer C, Campbell C, Toston R, Farley K, Daly C, Wagner ER. A Prospective Randomized Controlled Trial of Methylprednisolone for Postoperative Pain Management of Surgically Treated Distal Radius Fractures. J Hand Surg Am. 2022 Sep;47(9):866-873. doi: 10.1016/j.jhsa.2022.06.008. |
| D012216 |
| Rheumatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |