Clinical Evaluation of Moment Tumor Hip Replacement Products Within the Scope of Substantial Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 14
- 主要终点
- Rate of Adverse Events
研究概览
简要总结
The aim is to ensure that the patients are functionally adequately and painlessly mobilized with the proximal femoral tumor resection prosthesis used, to increase the survival of patients who underwent wide resection, and to determine the complications of the treatment applied and the clinical performance of the Moment Tumor Hip Replacement Products used.
详细描述
This study is a 6-center, prospective local medical device clinical trial. Trial period is 6 months. Patient recruitment will continue until the target sample number determined by the power analysis is reached. Since the application is surgical, it is within the scope of a one-time application. The patients will be followed for 6 months from the day of surgery. The study was designed as a prospective cohort study planned to be cross-sectional. The aim of this study is to ensure that the patients are functionally adequately and painlessly mobilized with the proximal femoral tumor resection prosthesis used, to increase the survival of patients who underwent wide resection, and to determine the complications of the treatment applied and the clinical performance of the Moment Tumor Hip Replacement Products used and to contribute to the medical literature on proximal femoral resection prosthesis as a result of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of both sexes aged 18-79 years
- •For patients with bone loss, fractures, pseudarthrosis due to primary-secondary metastases in the hip femoral region, patients belonging to one or more of the following groups
- •Patients with or with bone resections due to infection
- •Patients with unsuccessful femoral component applications
- •Patients in need of long-term stabilization of major bone defects caused by fractures with major and irreversible bone loss, periprosthetic fractures, traumatic non-tumor conditions affecting the trunks of the long bones, and comminuted fractures
- •Patients with severe pain and loss of function in the proximal femoral region
- •Patients with incompetence of the upper end of the femur or femoral neck fracture in hip replacement revisions.
- •Have sufficient mental and physical capacity to sign the informed consent form for the procedure
排除标准
- •Be under the age of 18 and over the age of 79
- •Pregnancy
- •Breastfeeding
- •Patients with bone tumors near the implant
- •Patients with acute or chronic infections (local or systemic) that reduce the adhesion resistance of the implant.
- •Patients with defective bone structures that may prevent proper fixation of the implant and severe deterioration or axial deviation affecting bone quality
- •Patients with inadequate bone quantity and quality as a result of osteoporosis
- •Patients with underdeveloped skeletal structure
- •Patients with vascular and neuromuscular disorders or muscular dystrophy and advanced muscle atrophy
- •Patients with impaired blood flow caused by vascular changes due to previous surgical procedure, alcohol use, etc.
- •Patients with more than expected implant overload due to obesity and/or vigorous physical activity or strain (such as sports, activities requiring physical activity)
- •Patients with inflammatory degenerative joint disease
- •Patients with pathologies that prevent surgical intervention
- •Patients whose general condition is not good and who cannot handle anesthesia
- •Patients who are uncoordinated or unwilling to operate, or who cannot follow instructions
- •Patients with mental retardation who do not or cannot comply with post-operative care instructions
- •Patients with neuropathic osteoarthropathy (charcot joint) joint disease
- •Patients with multiple organ failure
- •Patients with sepsis
- •Patients with syndromes or concomitant diseases that may adversely affect the evaluation of patients due to its systematic involvement.
- •Patients whose follow-up is not clinically or ethically appropriate due to complications that may develop during the study
结局指标
主要结局
Rate of Adverse Events
时间窗: 6 Months
Reliability of the procedure (adverse events occurring)
Hip pain and function for 6 months after the procedure according to the MSTS scoring
时间窗: 6 Months
Hip pain and function for 6 months after the procedure according to the MSTS scoring
Change in Quality of life
时间窗: 6 Months
Determination of the change in quality of life from baseline to 6 month after the procedure
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 6 Months
Toleratibily of the patients for the procedure.
次要结局
- Procedure's Safety(6 Months)
- Improvement in Functional Parameters(6 Months)
- Complications(6 Months)