NCT01879215已完成不适用
Patella Femoral Changes Following Tibial Nailing: Does Approach Matter?
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- T1Rho MRI to quantify patellofemoral cartilage changes after IM nailing of the tibia as a primary treatment for acute tibial fractures.
研究概览
简要总结
This study will utilize T1-Rho MRI to evaluate the effect of intramedullary nailing on patellofemoral articular cartilage when the surgery is performed using the infrapatellar vs. the suprapatellar approach. Subjects will be randomized to one or the other standard care surgical approaches.
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
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated tibial shaft fractures indicated for intramedullary nailing,
- •Acute tibia fractures,
- •Closed or open tibia fractures,
- •Skeletally mature patient between the ages of 21 and 50,
- •No prior history of knee surgery,
- •No prior history of knee pain,
- •No history of degenerative joint disease or inflammatory arthropathy
- •Not pregnant or known to be under the jurisdiction of the Department of Corrections
- •Able to provide informed consent.
- •Qualifies for standard care tibial IM nailing using either a suprapatellar or infrapatellar approach with no physician preference or definitive clinical indication for one or the other approach
- •Ability to communicate, read, and write in English
- •Intent of subject to receive follow up fracture care at the PI's institution.
排除标准
- •Tibial fractures requiring articular reconstruction (tibial plateau fractures and pilon fractures),
- •Periprosthetic fractures,
- •Nonunions or malunions,
- •History of previous knee surgery,
- •History of preexisting knee pain,
- •History of degenerative arthritis or inflammatory arthropathy, any evidence of degenerative changes of pre-operative knee radiographs, and any concomitant injury to that limb.
- •Any contraindication to MRI imaging
- •Retained stainless steel hardware proximal to the knee joint including, but not limited to prior knee replacement.
- •Under age 18 at the time of presentation, pregnant or planning to become pregnant within the study period, or under the jurisdiction of the Department of Corrections.
- •Inability to provide informed consent
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
- •Insurance or other circumstantial restriction that would prohibit or interfere with the subject's ability to receive follow up care at the PI's institution.
- •Any condition, acute or chronic, that in the opinion of the attending physician or the Principal Investigator, would contraindicate participation in this study.
结局指标
主要结局
T1Rho MRI to quantify patellofemoral cartilage changes after IM nailing of the tibia as a primary treatment for acute tibial fractures.
时间窗: Up to 6 months post-discharge
The difference in proteoglycan content of patellofemoral articular cartilage as quantified using spin lattice relaxation in a rotating frame (T1ρ MRI weighted image) at 6 months post-hospital discharge between two groups randomized to undergo either a suprapatellar or infrapatellar approach to tibial IM nailing.
次要结局
- SF-36(Pre-op, 2 week scan, 6 months post discharge)
- SMFA(Pre-op, 2 week scan, 6 months post discharge)
研究者
研究点 (2)
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