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临床试验/NCT07605923
NCT07605923尚未招募4 期

Methylprednisolone Addition to Multimodal Pain Regimens After Anterior Cruciate Ligament Reconstruction

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2026年9月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
64
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 14-65
  • undergoing ACL Reconstruction.

排除标准

  • contraindications to corticosteroids

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amit Momaya

Associate Professor

University of Alabama at Birmingham

研究点 (1)

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