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NCT Number: NCT07605923

Methylprednisolone Addition to Multimodal Pain Regimens After Anterior Cruciate Ligament Reconstruction

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.

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Key information

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 14-65
  • undergoing ACL Reconstruction.

Exclusion criteria

  • contraindications to corticosteroids

Treatment and study plan

Methyl Prednisolone (MP)

Drug

Participants will receive 4mg oral tablet of methylprednisolone taper for 6 days after surgery.

Other names: Corticosteroid

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.

Primary outcomes

  1. Average Narcotic Consumption Post Surgery

    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.

  2. Percentage of overall Pain Post Operatively

    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.

Secondary outcomes

  1. Change in Range of Motion

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amit Momaya, MD

CONTACT

[email protected]

(205) 930-8339

Crystal Taylor

CONTACT

[email protected]

205-807-4050

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
May 26, 2026
Registry last updated
May 26, 2026

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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