Radiological Evaluation of 3D Printed Porous Collars in Resection Prostheses Hip and Knee: Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Radiological evaluation
研究概览
简要总结
This study aims to evaluate the osseointegration of 3D printed porous collars in hip and knee resection prostheses, in order to eliminate one of the causes of diaphyseal osteolysis, which often lead to loosening of the implants, and therefore to guarantee a further improvement in fixation of the implants in terms of both primary and secondary stability.
详细描述
Non-interventional, retro-prospective, non-pharmacological multicenter pilot study.
The objective of the study is the radiological and clinical evaluation of collar osteointegration porous 3D printed in hip and knee resection prostheses.
Aims to enroll patients undergoing resection prosthesis surgery hip and knee with the use of 3D printed porous collars, performed according to normal practice clinic at the institutions participating in the study.
It is structured in a retrospective part which will evaluate the patients for whom follow-up data is available at the time of the start of the study up to at least 1 year after the operation. And a prospective part (both with regard to patients not yet subjected to intervention, at the start of the study, according to the inclusion criteria, both regarding those in follow-up for whom data are not available according to the time of observation required (1 year)) which will begin once all the necessary authorizations have been obtained administrative requests.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •age > 18 years at the time of surgery.
- •patients undergoing hip and knee resection prosthesis surgery with the use of collars porous 3D printed.
- •date of intervention: starting from the regular entry into use of 3D printed porous collars at the reference center.
- •Patients operated on for primary tumor outcomes.
- •Patients operated on for infection.
- •Patients operated for revisions with severe loss of bone substance.
- •Patients capable of giving informed consent and obtaining written informed consent (prospective part/patients in follow-up).
排除标准
- •Patients lost to follow-up and/or for whom radiographic and clinical documentation is not available corresponding to the post-operative moment and the clinical follow-up visit (6 months and 1 years).
结局指标
主要结局
Radiological evaluation
时间窗: 6 months and 1 year
Osseointegration will be assessed by x-ray analysis 6 months and 1 year after surgery
次要结局
- QoL evaluation(6 months and 1 year)