Methylprednisolone Addition to Multimodal Pain Regimens After Anterior Cruciate Ligament Reconstruction

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07605923
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • ACL Reconstruction

Eligibility Criteria

Sex
ALL
Age
14 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Methyl Prednisolone (MP) — DRUG
    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.

Study Details

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 Dates

Start date
Sep 30, 2026
Status verified
May 2026
Primary completion
Aug 31, 2031
Completion
Aug 31, 2031

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group
    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.
  • Active Comparator: Control Group
    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.

Primary Outcome Measure

Average Narcotic Consumption Post Surgery [ Time Frame: Daily up to 6 days and 1 week post op ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Amit Momaya, MD
[email protected]
(205) 930-8339
Crystal Taylor
[email protected]
(205) 807-4050
Amit Momaya, MD (PRINCIPAL_INVESTIGATOR)

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