NCT02450292已完成不适用
Retrospective CT Imaging of BioComposite Interference Screw in Patients Undergoing Anterior Cruciate Ligament Reconstruction With Bone-Patellar Tendon-Bone Graft
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 主要终点
- Screw resorption
研究概览
简要总结
The purpose of this study is to examine the long-term appearance and resorption rate of biocomposite screws used during ACL reconstruction on X-ray and computed tomography (CT).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-50
- •Patients who underwent primary ACL reconstruction performed by one of the study investigators at least 5 years ago
- •Isolated ACL tear
- •Type of graft used was bone-patellar tendon-bone autograft
- •Type of screw used to attach graft to the tibia and/or femur was a BioComposite interference screws (Arthrex, Inc.)
- •No degenerative joint disease on preoperative X-rays (> 50% joint space loss, presence of osteophytes)
排除标准
- •Revision ACL reconstructions
- •Types of grafts other than bone-patellar tendon-bone autograft were used
- •ACL tear with concomitant pathology
- •Degenerative joint disease on preoperative X-ray (> 50% joint space loss, presence of osteophytes)
- •Metal or other types of bioabsorbable screws other than BioComposite interference screws (Arthrex, Inc.) were used
- •ACL reconstruction performed less than 5 years ago
- •Pregnancy
- •Greater than Grade 2 laxity of other ligaments
- •No additional fixation
结局指标
主要结局
Screw resorption
时间窗: 5 years
Evaluated on X-ray and CT
次要结局
未报告次要终点
研究者
Marc Fineberg
Chief of Sports Medicine, Associate Professor of Clinical Orthopaedics
State University of New York at Buffalo
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