Early Outcomes Utilizing the TRUMATCH Graft Cage for Segmental Long Bone Defects: A Case Series
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Use of the TRUMATCH Graft Cage- Long Bone
研究概览
简要总结
This project consists of a prospective case design. Study candidates will include all patients ages 18 and over who were evaluated at UCSD and found to have a critical-sized humerus, femur, or tibia segmental defect that would be fixed through surgery. Patients who consent to study participation will receive the TRUMATCH Graft Cage for their long bone segmental defect repair. Data on healing rates, complication rates, re-operation rates, time to return to normal activity, and pain levels will be collected for each participation. After 3 years of data collection, we will analyze this data to provide further insight on the utility of the TRUMATCH Graft Cage. Given the significant difficulty with repairing segmental long bone defects, it is imperative to evaluate novel systems to appropriately manage these injuries.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Humerus, femur, or tibia segmental defects requiring surgery
- •Evaluation and treatment at UCSD
- •Ages 18 year and older
- •Abiltiy to understand the content of the patient information/informed consent form
排除标准
- •Any not medically managed severe systemic disease
- •Their doctor has decided that it is in the patient's best interest to receive a different method of repair
- •Their doctor has determined that the patient has a condition that would make them unsuitable for participation in the study
- •Pregnancy or women planning to conceive within the subject participation period (1 year) note: pregnancy will be self-reported and no test will be performed to test for it
- •Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study.
结局指标
主要结局
Use of the TRUMATCH Graft Cage- Long Bone
时间窗: 2 years
次要结局
- Healing Rates(2 years)
- Complications(2 years)
- Pain Scores(2 years)
- Reoperation Rates(2 years)
- Time to Return to Normal Activity(2 years)
研究者
William Kent
Assistant Professor of Orthopaedic Surgery
University of California, San Diego