University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Location contact
Amit Momaya, MD
CONTACT
Amit Momaya, MD
PRINCIPAL_INVESTIGATOR
Crystal Taylor
CONTACT
NCT Number: NCT07605923
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.
Trial opening soon.
Get Notified14 year–65 year
All sexes
Interventional
Phase 4
Birmingham, Alabama, 35294, United States
Amit Momaya, MD
CONTACT
Amit Momaya, MD
PRINCIPAL_INVESTIGATOR
Crystal Taylor
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive 4mg oral tablet of methylprednisolone taper for 6 days after surgery.
Other names: Corticosteroid
All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen.
All patients will receive the surgeon's standard ACL postoperative multimodal pain regimen.
Time frame: Daily up to 6 days and 1 week post op
Paricipants will be assessed on the average amount of pain medication taken on a daily basis.
Time frame: Daily for 7 days post op
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.
Time frame: baseline, 2 weeks, 6 weeks and 3 months
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.
Contact information is provided by the study sponsor or research team.
Amit Momaya, MD
CONTACT
Crystal Taylor
CONTACT
University of Alabama at Birmingham
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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