Methylprednisolone Addition to Multimodal Pain Regimens After Anterior Cruciate Ligament Reconstruction

NCT07605923 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: IRB-300016646UAB
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ACL Reconstruction

Keywords

ACL; Anterior Cruciate ligament reconstruction; postoperative pain; corticosteroid taper; methylprednisolone taper; multimodal pain protocol

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Range of Motion

  baseline, 2 weeks, 6 weeks and 3 months

Study Arms (2)

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.

Drug: Methyl Prednisolone (MP); Combination Product: Surgeon's Standard ACL Postoperative Regimen

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.

Drug: Standard Post-Operative Pain Control; Combination Product: Surgeon's Standard ACL Postoperative Regimen

Interventions

Methyl Prednisolone (MP) DRUG

Participants will receive 4mg oral tablet of methylprednisolone taper for 6 days after surgery.

Also known as: Corticosteroid

Treatment Group

Surgeon's Standard ACL Postoperative Regimen COMBINATION_PRODUCT

All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen.

Control Group; Treatment Group

Standard Post-Operative Pain Control DRUG

All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen.

Control Group

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 14-65
• undergoing ACL Reconstruction.

You may not qualify if:

• contraindications to corticosteroids

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• 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.

  PMID: 38316236 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Amit Momaya, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Momaya, MD

CONTACT

(205) 930-8339; amomaya@uabmc.edu

Crystal Taylor

CONTACT

205-807-4050; crystalmtaylor@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2031
• Study Completion (Estimated): August 1, 2031
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)