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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Identifier | UAB |
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Patients who are being seen for ACL tears will be approached in the UAB Orthopedic Clinic. Included patients will be those aged 14-65 undergoing ACL Reconstruction. Excluded patients will be those with contraindications to corticosteroids. If the patient meets the criteria and agrees to participate, then the consent form will be signed, and the patient will be enrolled. Enrolled patients will be randomized to one of two groups. Patients in the treatment group will receive a 4 mg oral 6-day methylprednisolone taper in addition to standard post-operative pain control. Patients in the control group will receive standard post-operative pain control. All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen. Endpoints will include narcotic consumption assessed daily and at one week post-op through a patient self-reported diary. The VAS pain score will be collected each day for the first week. Secondary endpoints will include range of motion and patient-reported outcomes, including IKDC, KOOS Jr, Tegner Activity Scale, ACL-RSI, and PROMIS Global collected at baseline, 2 weeks, 6 weeks and 3 months. All outcomes will be collected through PatientIQ.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Patients in the treatment group will receive a 4 mg oral 6-day methylprednisolone taper in addition to standard post-operative pain control. All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen. |
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| Control Group | Active Comparator | Patients in the control group will receive standard post-operative pain control. All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methyl Prednisolone (MP) | Drug | Participants will receive 4mg oral tablet of methylprednisolone taper for 6 days after surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Narcotic Consumption Post Surgery | Paricipants will be assessed on the average amount of pain medication taken on a daily basis. | Daily up to 6 days and 1 week post op |
| Percentage of overall Pain Post Operatively | Participants will be evaluated using the Visual Analogue Scale (VAS) for pain is a self-reported tool, typically a 10-cm horizontal line, anchored by "no pain" (0 cm) and "worst pain" (10 cm). Patients mark their pain level, offering a simple, sensitive, and highly subjective assessment for acute, chronic, or disease-specific pain. | Daily for 7 days post op |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Range of Motion | Participants will be measured on their range of motion after surgery using a goniometer. An instrument used to measure joint angles (range of motion) in rehabilitation and physical therapy, or to determine precise angular positions in engineering and physics. | baseline, 2 weeks, 6 weeks and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amit Momaya, MD | Contact | (205) 930-8339 | amomaya@uabmc.edu | |
| Crystal Taylor | Contact | 205-807-4050 | crystalmtaylor@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amit Momaya, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| 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. |
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| Standard Post-Operative Pain Control | Drug | All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen. |
|
| Surgeon's Standard ACL Postoperative Regimen | Combination Product | All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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