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NOT YET RECRUITING
NCT07605923
PHASE4

Methylprednisolone Addition to Multimodal Pain Regimens After Anterior Cruciate Ligament Reconstruction

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

14 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2026-09

Completion Date

2031-08

Last Updated

2026-05-26

Healthy Volunteers

No

Interventions

DRUG

Methyl Prednisolone (MP)

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

DRUG

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.

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States