Methylprednisolone Addition to Multimodal Pain Regimens After Anterior Cruciate Ligament Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methyl Prednisolone (MP), Standard Post-Operative Pain Control, Surgeon's Standard ACL Postoperative Regimen.
- Who it may be relevant to
- Registry conditions: ACL Reconstruction. Basic parameters: 14 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Average Narcotic Consumption Post Surgery [Time frame: Daily up to 6 days and 1 week post op]
- Percentage of overall Pain Post Operatively [Time frame: Daily for 7 days post op]
Secondary outcome measures (1)
- Change in Range of Motion [Time frame: baseline, 2 weeks, 6 weeks and 3 months]
Eligibility criteria
Inclusion criteria
- aged 14-65
- undergoing ACL Reconstruction.
Exclusion criteria
- contraindications to corticosteroids
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
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
Identifiers
NCT: NCT07605923 · IRB-300016646 · UAB