Methylprednisolone Addition to Multimodal Pain Regimens After Anterior Cruciate Ligament Reconstruction

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.

Study Overview

• Status: Not yet recruiting
• Conditions: ACL Reconstruction
• Intervention / Treatment: Drug: Methyl Prednisolone (MP); Combination product: Surgeon's Standard ACL Postoperative Regimen; Drug: Standard Post-Operative Pain Control

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Amit Momaya, MD; Phone Number: (205) 930-8339; Email: amomaya@uabmc.edu
• Study Contact Backup: Name: Crystal Taylor; Phone Number: 205-807-4050; Email: crystalmtaylor@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
      • Contact: Amit Momaya, MD; Phone Number: (205) 930-8339; Email: amomaya@uabmc.edu
      • Contact: Crystal Taylor; Phone Number: (205) 807-4050; Email: crystalmtaylor@uabmc.edu
      • Principal Investigator: Amit Momaya, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• aged 14-65
• undergoing ACL Reconstruction.

Exclusion Criteria:

• contraindications to corticosteroids

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; 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.	Drug: Methyl Prednisolone (MP); Participants will receive 4mg oral tablet of methylprednisolone taper for 6 days after surgery.; Other Names: Corticosteroid; Combination product: Surgeon's Standard ACL Postoperative Regimen; All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen.
Active Comparator: Control Group; 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.	Combination product: Surgeon's Standard ACL Postoperative Regimen; All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen.; Drug: Standard Post-Operative Pain Control; All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Amit Momaya, MD, University of Alabama at Birmingham

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2031
• Study Completion (Estimated): August 1, 2031

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ACL; postoperative pain; Anterior Cruciate ligament reconstruction; multimodal pain protocol; corticosteroid taper; methylprednisolone taper
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenal Cortex Hormones
• Other Study ID Numbers: IRB-300016646; UAB (Other Identifier: UAB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No