Methylprednisolone Addition to Multimodal Pain Regimens After Anterior Cruciate Ligament Reconstruction

NCT07605923 — Phase 4, Not yet recruiting, 64 participants, University of Alabama at Birmingham

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Registry	NCT07605923
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	64 (Estimated)
Sponsor	University of Alabama at Birmingham (Other)
Conditions	ACL Reconstruction
Interventions	Methyl Prednisolone (MP), Standard Post-Operative Pain Control, Surgeon's Standard ACL Postoperative Regimen (Drug, combination product)
Dates	start 2026-09-01 (estimated), primary completion 2031-08-01 (estimated), completion 2031-08-01 (estimated), first posted 2026-05-26, last updated 2026-05-26
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Treatment Group	Experimental	Drug: Methyl Prednisolone (MP); Combination Product: Surgeon's Standard ACL Postoperative Regimen	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.
Control Group	Active comparator	Drug: Standard Post-Operative Pain Control; Combination Product: Surgeon's Standard ACL Postoperative Regimen	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.

Methyl Prednisolone (MP) (Drug), also known as Corticosteroid: Participants will receive 4mg oral tablet of methylprednisolone taper for 6 days after surgery.
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.

+Outcome measures

Primary outcomes

Average Narcotic Consumption Post Surgery [Daily up to 6 days and 1 week post op]: Paricipants will be assessed on the average amount of pain medication taken on a daily basis.
Percentage of overall Pain Post Operatively [Daily for 7 days post op]: 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.

Secondary outcomes

Change in Range of Motion [baseline, 2 weeks, 6 weeks and 3 months]: 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.

+Eligibility

Sex: All, ages: 14 Years to 65 Years

Inclusion Criteria:

* aged 14-65
* undergoing ACL Reconstruction.

Exclusion Criteria:

* contraindications to corticosteroids

+Locations (1)

Facility	City	Country	Status
University of Alabama at Birmingham	Birmingham, Alabama	United States

+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. PMID 38316236

+Investigators

Amit Momaya, MD, Principal investigator, University of Alabama at Birmingham