Methylprednisolone taper plus standard pain medicines after ACL repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, single-center study enrolls consecutive patients aged 13–50 undergoing primary ACL repair or reconstruction with autograft and follows them for one year. Participants are randomized to a treatment pain regimen that includes a methylprednisolone dose-pack, meloxicam, hydrocodone/acetaminophen, and gabapentin, or to a control regimen of ketorolac, hydrocodone/acetaminophen, and gabapentin. Pain scores and daily opioid pill consumption are reported using the MyCap app the day of surgery and for the first 14–15 postoperative days, and clinic follow-ups occur at 2 weeks, 6 weeks, 12 weeks, and 1 year with collection of PROMs and complications. Demographic, comorbidity, and surgical data are collected from the medical record to compare outcomes between groups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient undergoing ACL repair or ACL reconstruction with tendon autograft
* Age 13-50 years old
* Able to provide informed consent or parent/legal guardian is able for minors

Exclusion Criteria:

* Concurrent and significant injury to other bones or organs (Injury Severity Score of 4 or greater)
* Revision ACL reconstruction
* Concomitant additional ligament reconstruction or high tibial osteotomy
* A history of alcohol abuse, substance abuse or chronic opioid use (filled opioid medication ×2 within 6 months of the surgery)
* A history of renal failure (\<60 mL/min/1.73 m2), liver dysfunction (child class, \>B), severe heart disease (NYHA Class 4), diabetes, neurological or psychiatric diseases that may affect pain perception, and pre-existing immune suppression.
* A history or active peptic ulcer disease, gastrointestinal bleeding, or current use of anticoagulation.
* Patients currently taking oral or injectable glucocorticoids and those who have taken either within 1 month of the procedure.
* Patients who are currently pregnant.
* Patients who are unable to undergo the multimodal pain standardized protocol including those with comorbidities or medical allergies precluding the use of corticosteroids, gabapentin, hydrocodone, acetaminophen, ketorolac, and/or meloxicam.

Where it's running

• Saint Louis University
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Scott Kaar, MD — St. Louis University
• Study coordinator: Scott Kaar
• Email: scott.kaar@ssmhealth.com
• Phone: 314-617-3405

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.