NCT07158476 Efficacy of Methylprednisolone for Pain Control After ACL Repair
| NCT ID | NCT07158476 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | St. Louis University |
| Condition | ACL Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-10-21 |
| Primary Completion | 2030-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2025-10-21 with a primary completion date of 2030-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Opioids are commonly used after orthopedic surgery for pain control but have been shown to increase complications, surgeries, readmissions, and risk for opioid use disorder. The purpose of this study is to investigate the impact of adding a methylprednisolone taper to the pain regimen after ACL repair surgery to determine if this results in decreased postoperative pain and opioid use without increasing complications.
Eligibility Criteria
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.
Contact & Investigator
Scott Kaar, MD
PRINCIPAL INVESTIGATOR
St. Louis University
Frequently Asked Questions
Who can join the NCT07158476 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 50 Years, studying ACL Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07158476 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07158476 currently recruiting?
Yes, NCT07158476 is actively recruiting participants. Contact the research team at scott.kaar@ssmhealth.com for enrollment information.
Where is the NCT07158476 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT07158476 clinical trial?
NCT07158476 is sponsored by St. Louis University. The principal investigator is Scott Kaar, MD at St. Louis University. The trial plans to enroll 90 participants.