Compare the Efficacy of Long-nailed and Short-nailed Fixation for Proximal Femur Metastasis - a Non-inferior Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Reoperation rate
研究概览
简要总结
The goal of this interventional randomized controlled trial is to compare the clinical outcomes in treating extremities pathological fractures (fractures of limbs caused by metastatic tumors) or impending pathological fractures with short or long intramedullary nails. The main questions it aims to answer are:
- What is the rate of developing new distant metastasis of the operated extremities?
- Does treating extremities (impending) pathological fractures with long intramedullary nails have lower or similar reoperation rate than the short nails?
- Are there any differences when comparing the surgical-related complication, functional outcomes and life quality assessment between treating extremities (impending) pathological fractures with long or short intramedullary nails.
Participants who meet surgical indication will be randomized into either the long or short intramedullary nail group after informed consent. The patient will receive bone fixation with the corresponding prosthesis.
详细描述
Participants will be randomized into either long or short intramedullary nail groups. Participants in the long intramedullary nail group will be fixed with a longer intramedullary nail (defined as greater than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures, while patients in the short intramedullary nail group will be fixed with a shorter intramedullary nail (defined as less than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures. Follow-up will be performed at 1, 3, 6, and 12 months after surgery to analyze the patient's function, blood sampling values, and imaging follow-up. The functional capacity will be evaluated by PROMIS questionnaire.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Femur (impending) pathological fracture that is suitable for intramedullary nail fixation as determined by the physician
- •Patient is willing to participate in this clinical trial and cooperate with follow-up
排除标准
- •The patient has a more appropriate treatment alternative to single intramedullary nail fixation as determined by the multidisciplinary decision, such as,
- •The metastatic lesions involved the femur head
- •The metastatic lesions involved the pelvis
- •The metastatic lesions compromised the greater or lesser trochanter to a certain extent that arthroplasty was indicated
- •The metastatic lesions involved/occurred more distal than the intertrochanteric line
- •There are justified, clinically significant rationales that either long or short intramedullary nails be a more appropriate treatment during pre-operative assessment
- •The patient has imaging-confirmed distant femoral metastases before treatment
- •Patient has renal cell carcinoma or sarcoma
- •Patient is unable to cooperate with follow-up or to understand the trial protocol
- •Patient is unable to communicate in Chinese
结局指标
主要结局
Reoperation rate
时间窗: Up to 1 year after the intervention
Percentage of patients receiving revision surgery within 1 year after the intervention. The primary outcome should be compared using non-inferior tests. The non-inferior margin was pre-specified at 25.4%.
次要结局
- Change from baseline in functional outcome on the Patient-Reported Outcomes Measurement Information System-29 scoring at 1,3,6,12 months after the intervention(At 1,3,6,12 months after the intervention)
- Cardiopulmonary complication rate within 30 days after the intervention(Up to 30 days after the intervention)
- Mortality rate at 1,3,6,12 months after the intervention(At 1,3,6,12 months after the intervention)
- Percentage of of participants with distant femoral metastasis(Up to 1 year after the intervention)
- Cost-effectiveness analysis(Up to 2 year after the intervention)