About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged 14-65
undergoing ACL Reconstruction.
Disqualifiers
contraindications to corticosteroids
Trial design
Parallel
Treatments tested in this trial
Methyl Prednisolone (MP)
DrugParticipants will receive 4mg oral tablet of methylprednisolone taper for 6 days after surgery.
Standard Post-Operative Pain Control
DrugAll patients will receive the surgeon's standard ACL postoperative multimodal pain regimen.
Surgeon's Standard ACL Postoperative Regimen
Combination productAll patients will receive the surgeon's standard ACL postoperative multimodal pain regimen.
Treatment groups
Trial outcomes
Primary outcomes
Average Narcotic Consumption Post Surgery
Paricipants will be assessed on the average amount of pain medication taken on a daily basis.
Percentage of overall Pain Post Operatively
Participants will be evaluated using the Visual Analogue Scale (VAS) for pain is a self-reported tool, typically a 10-cm horizontal line, anchored by "no pain" (0 cm) and "worst pain" (10 cm). Patients mark their pain level, offering a simple, sensitive, and highly subjective assessment for acute, chronic, or disease-specific pain.
Secondary outcomes
Change in Range of Motion
Participants will be measured on their range of motion after surgery using a goniometer. An instrument used to measure joint angles (range of motion) in rehabilitation and physical therapy, or to determine precise angular positions in engineering and physics.
Sponsors and contacts
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