Surgical Management of Posterior Tibial Plateau Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Radiographic evaluation
研究概览
简要总结
This protocol concerns an academic, multicentric, and prospective clinical trial. In this study the investigators will evaluate the recently approved WAVE-plate (7S Medical) for open reduction and internal fixation and buttressing of the posterior proximal tibial column via a posteromedial reversed L-shaped approach. The reversed L-shaped approach has been shown as a safe technique with adequate visualisation of the posterior tibial surface. The investigators will thoroughly evaluate all important clinical, radiological and functional variables. The functional outcome will be reported in patient reported outcome measures by means of the validated Knee injury and Osteoarthritis Outcome Score (KOOS).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tibial plateau fracture with involvement of posterior proximal tibial plateau (according to revised three-column classification), requiring osteosynthesis
排除标准
- •Absent contact information
- •living abroad and cannot participate in the follow-up visits
- •non-functional leg prior to treatment/injury
- •pathological fractures
- •bilateral fractures
结局指标
主要结局
Radiographic evaluation
时间窗: 1 year
Parameters derived from CT and RX.
Subjective evaluation: outcome
时间窗: 1 year
Total Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire to measure patient's opinion about his or her knee and the associatede problems.
Subjective evaluation: pain
时间窗: 1 year
Visual analogue scale (VAS) to indicate the daily pain level.
Clinical evaluation
时间窗: 1 year
Recording of demographic and fracture-related characteristics.
次要结局
- Complications(1-7 days post-operatively, 8 weeks, 12 weeks, 6 months, 9 months, 1 year)
研究者
Harm Hoekstra, prof. dr.
Prof. Dr. Harm Hoekstra
Universitaire Ziekenhuizen KU Leuven