Efficacy of the Use of 3D Printing Models in the Treatment of Tibial Plateau Fractures: a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Fluoroscopy time.
研究概览
简要总结
TIBIA3D is a randomized, open and prospective clinical trail that evaluates the use of preoperative 3D printing in the surgical treatment of patients with tibial plateau fractures
详细描述
Randomized, open and prospective study.
Once the surgical indication for osteosynthesis has been established after having suffered a tibial plateau fracture, the patients will be randomized in a 1:1 ratio to one of the tfollowing treatment groups:
Control group: images obtained by plain radiography and computed tomography are used in the planning of osteosynthesis of the tibial plateau fracture.
Experimental group: in the planning of tibial plateau fracture osteosynthesis, in addition to images obtained by plain radiography and computed tomography, a three-dimensional plastic model printed by processing the tomography images is used.
Patients (or their legal representatives) must sign the consent before randomization.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with tibial plateau fracture requiring surgical treatment.
- •Age equal to or greater than 18 years.
- •Signature of informed consent in writing according to current legislation before collecting any information.
排除标准
- •Pregnancy in progress.
- •Presence of serious systemic pathology or another situation that contraindicates treatment
- •Presence of other fractures in the ipsilateral femur or tibia that condition the surgical treatment of the tibial plateau fracture.
- •Findings in the physical examination, in the results of the tests or other medical, social or psychopathological factors that, in the opinion of the investigators, could negatively influence the study.
- •Inability to grant informed consent in the absence of a legal representative.
- •Inability to follow instructions or collaborate during the development of the study.
研究组 & 干预措施
Experimental group
Planning of tibial plateau fracture osteosynthesis by using a three-dimensional model of the fracture.
干预措施: Open reduction and internal fixation (Procedure)
Experimental group
Planning of tibial plateau fracture osteosynthesis by using a three-dimensional model of the fracture.
干预措施: Standard osteosynthesis planning (Procedure)
Experimental group
Planning of tibial plateau fracture osteosynthesis by using a three-dimensional model of the fracture.
干预措施: 3-D model osteosynthesis planning (Procedure)
Control group
Standard planning of tibial plateau fracture osteosynthesis (by plain radiography and computed tomography imaging).
干预措施: Open reduction and internal fixation (Procedure)
Control group
Standard planning of tibial plateau fracture osteosynthesis (by plain radiography and computed tomography imaging).
干预措施: Standard osteosynthesis planning (Procedure)
结局指标
主要结局
Fluoroscopy time.
时间窗: Week 1
Intraoperative fluoroscopy time will be counted after incision and before wound closure.
Surgical time
时间窗: Week 1
Surgical time will include the time from skin incision to wound closure
次要结局
- Ease of surgical planning with 3d printing(Week 1)
- Complications(Week 1 - 12 months)
研究者
Pedro-José Torrijos-Garrido
Principal Investigator
Puerta de Hierro University Hospital