Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of Participants With Bone Tunnel Expansion
研究概览
简要总结
The goal of this study is to determine whether the use of injectable osteoinductive/osteoconductive compounds (OOC) during Anterior Cruciate Ligament (ACL) reconstructive surgery, combined with an accelerated rehabilitation protocol (ARP) provides clinical outcomes superior to those attained via traditional ACL reconstruction and delayed rehabilitation protocols.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any adult undergoing a surgical procedure for hamstring ACL reconstruction
排除标准
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Standard Surgery with OOC
Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention
干预措施: OOC (Drug)
结局指标
主要结局
Number of Participants With Bone Tunnel Expansion
时间窗: up to 12 months post-surgery
Number of participants will be classified with having femoral and tibial tunnel expansion as: * minimal expansion (\<1mm) * mild expansion (\<5mm) * moderate expansion (5-10mm) * large expansion (\>10mm) as measured via Magnetic Resonance Imaging (MRI)
次要结局
- Graft Maturation(up to 12 months post-surgery)
- Number of Participants With Tunnel Ganglion Cyst Formation(up to 12 months post-surgery)
研究者
Francesco Travascio
Associate Professor
University of Miami