Structural Bicortical Autologous Iliac Crest Bone Graft Combined With Tunnel Bone Tamps Method for Depressed Tibial Plateau Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Postoperative immediate reduction rate
研究概览
简要总结
Autologous ICBG and bone tamp methods are often applied to manage depressed tibial plateau fracture (DTPF), but previous iliac bone harvesting and bone tamp techniques remain controversial. The purpose of this study is to describe and evaluate the technique of using structural bicortical autologous iliac crest bone-graft (ICBG) combined with tunnel bone tamps method (TBTM) in treating DTPFs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •adult patients (age ≥ 18 years);
- •diagnosis of DTPFs;
- •agreeing to receive structural bicortical autologous ICBG combined with TBTM treatment and subsequent internal fixation treatment;
- •agreeing to participate in regular follow-up after surgery.
排除标准
- •open fracture;
- •pathologic fractures;
- •bone metabolic disease;
- •previous ICBG;
- •infection or soft tissue injury of the iliac bone donor site;
- •pelvic fractures or bone tumors;
- •associated peripheral nerve injury;
- •non-completion of 30 months follow-up.
结局指标
主要结局
Postoperative immediate reduction rate
时间窗: up to 2 weeks
Preoperative and postoperative imaging data of all subjects, including X-ray and CT scans, were collected. Picture Archiving and Communication Systems (PACS) was used to measure articular step-off and evaluate the immediate reduction after surgery.
Postoperative long-term reduction rate
时间窗: up to 2 weeks
The immediate postoperative and follow-up imaging data of all subjects, including X-ray and CT scan, were collected. PACS system was used to measure the articular step-off and evaluate the long-term reduction after surgery.
Bone healing time
时间窗: up to 2 weeks
Postoperative follow-up imaging data of all patients were collected, including X-ray and CT scans.Evaluating the bone healing time based on callus growth.
次要结局
- intraoperative blood loss(up to 1 weeks)
- The incidence of complications in the bone-graft donor and bone-graft sites(up to 1 weeks)
- Hospital for Special Surgery score of knee(uo to 1 week)
- operative time(up to 1 weeks)
- the Visual Analog Scale scores of ICBG donor and bone-graft sites(up to 1 week)
- 36-Item Short-Form Health Survey score(up to 1 week)