Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of OMS103HP With Vehicle in Patients Undergoing Autograft ACL Reconstruction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 18
- 主要终点
- Improvement in knee function
研究概览
简要总结
The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma initiates an acute inflammatory response, including swelling and pain, that leads to restricted joint motion and loss of function. OMS103HP was designed to deliver targeted therapeutic agents directly to the surgical site during the arthroscopic procedure to inhibit inflammation and pain before they can begin.
The purpose of this study is to assess the effectiveness and safety of OMS103HP in improving knee function following ACL reconstruction using a hamstring autograft. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion, and earlier return to work.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •15 - 65 years of age
- •In good general health with an ACL tear that occurred from 2 weeks to 18 months prior to the day of arthroscopic surgery
- •Undergoing primary unilateral ACL reconstruction using a medial hamstring (semitendinosus and gracilis) autograft
- •Able to participate in the study rehabilitation protocol
- •and other inclusion criteria
排除标准
- •Allergies to any of the individual ingredients in OMS103HP
- •Taking medications with the same activities as that of the active ingredients in OMS103HP for defined time intervals prior to and after surgery
- •Associated knee injuries likely to interfere with evaluation of the study drug
- •and other exclusion criteria
研究组 & 干预措施
OMS103HP irrigation solution
Drug
干预措施: OMS103HP (Drug)
vehicle irrigation solution
Vehicle
干预措施: Vehicle (Drug)
结局指标
主要结局
Improvement in knee function
时间窗: 30 days
次要结局
- Decreased pain(30 days)
- Improved range of motion(30 days)
- Earlier return to work(30 days)