Metastatic Pathologic Fractures: Short Term Results of Endoprosthetic Reconstruction, Intramedullary Nail and Open Reduction Internal Fixation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Toronto Extremity Salvage Score (TESS)
研究概览
简要总结
This is a single center prospective study to compare the short term results of prosthesis, nail and plate-screw surgeries for metastatic pathologic fractures.
详细描述
The most common bone tumor in elderly is metastatic bone tumors. With the prolonged life expectancy in cancer patients, the management of the metastases became an essential topic.
Pathological fractures should be examined and managed with a different perspective. They usually cannot be healed by conservative methods and require surgical intervention. The primary goals of surgical intervention are to relieve pain and mobilize the patient as soon as possible.
The aim of the study is to compare the short-term functional endoprosthetic recontruction, intramedullary nailing and open reduction internal fixation.
The primary tumor of the patient, applied chemotherapy and radiotherapy, Mirel risk score, Charlson comorbidity index, and PathFx 3.0 survival will be evaluated preoperatively.
The type of the operation will be decided at the multidisciplinary tumor council of ankara University.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •metastatic pathologic fracture
- •operated via endoprosthesis, intramedullary nail or plate & screws
排除标准
- •primary bone tumor
- •conservative management
- •neuromuscular disease
- •periprosthetic fractures
- •less than 1 month follow up
结局指标
主要结局
Toronto Extremity Salvage Score (TESS)
时间窗: Postoperative 1st month
TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145.
Disabilities of Arm, Shoulder and Hand (DASH)
时间窗: Postoperative 1st month
DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.
Musculoskeletal Tumor Society (MSTS) score
时间窗: Postoperative 1st month
MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function.
Visual analog scale (VAS)
时间窗: Postoperative 1st month
VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.
Upper Extremity Functional Scale (UEFS)
时间窗: Postoperative 1st month
UEFS is a functional scale for upper extremity. It is not specific for tumor patients.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: Postoperative 1st month
WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.
Lower Extremity Functional Scale (LEFS)
时间窗: Postoperative 1st month
LEFS is a functional scale for lower extremity. It is not specific for tumor patients.
次要结局
- Days at hospital after surgery(up to 1 month)
- Survival(up to 3 months)
研究者
Merve Dursun Savran, MD
MD
Ankara University