A Clinical Trial to Investigate the Safety and Efficacy of SurgiFill™, a Bone Grafting Material, in Patients With Femur or Tibia Fracture.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Bone formation completion date
研究概览
简要总结
This study is designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with femur or tibia fracture.
详细描述
This study is an open-trial study. The purpose and procedure of study will be explained to the subjects, and they will voluntarily decide to participate in it. Their eligibility to participate in the study will be checked, and the subjects will be randomized into the study group or the control group (via stratified randomization) based on the severity of their disease and the surgery method. The study group will receive treatment for fracture (fixation) and SurgiFill™ injection, and the control group will receive only fracture treatment. For the fracture treatment, open-reduction internal fixation, a surgery method that involves incision of the fractured area and fixation with a metal plate or a metal nail, will be performed. They will be asked to follow the guidelines of the investigators during the study and to visit the hospital seven times, including for screening. At each visit, the subjects will undergo an examination with doctors and a X-ray procedure to evaluate the safety and efficacy of SurgiFill™.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with closed fracture out of the joint from below the trochanter of the femur up to the distal femur or in the tibia
- •Patients who agreed to participate in the study and signed the informed consent form
排除标准
- •Patients or their family members with a history of an or an ongoing autoimmune disease
- •Patients with a history of anaphylactic response
- •Patients with hypersensitivity to grafting materials
- •Patients with hypersensitivity to porcine protein
- •Patients with osteomyelitis in the surgery area
- •Patients who are pregnant, breastfeeding, or planning to become pregnant
- •Patients with other tumors or a non-curable disease
- •Patients with a history of radiation therapy or cancer treatment within two years (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.)
- •Patients with diabetes (Those who maintain a normal blood sugar level and did not develop complications may receive the SurgiFill™ injection based on the investigator's judgment, but the doctor's confirmation is required.)
- •Patients with an infection that required hospitalization for antibiotics or the administration of antiseptic agents
- •Patients who have been undergoing adrenocortical hormone therapy (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.)
- •Patients with liver, heart, or kidney disease (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment. Hypertension patients are allowed.)
- •Patients who had been infected with a virus (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.)
- •Patients with chronic renal failure or an endocrine system disease (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.)
- •Patients who are considered inappropriate for participation in this study due to their condition (e.g., a mental illness) based on the investigator's judgment
- •Patients who had participated in another clinical trial (limited to those who participated in other studies on fracture within the last six months.)
研究组 & 干预措施
SurgiFill™ on femur or tibia fracture
The study group will receive treatment for fracture and SurgiFill™ injection.
干预措施: femur or tibia fracture (Procedure)
SurgiFill™ on femur or tibia fracture
The study group will receive treatment for fracture and SurgiFill™ injection.
干预措施: SurgiFill™ (Device)
Treatment on femur or tibia fracture
The control group will receive only fracture treatment.
干预措施: femur or tibia fracture (Procedure)
结局指标
主要结局
Bone formation completion date
时间窗: at time of bone formation completion
The investigators will evaluate the bone formation and record the date of completion of the bone formation. The criteria for the bone formation completion are when the third callus has formed completely and when the patient no longer feels pain when he or she bears his or her full weight on his or her treated leg.
次要结局
- Callus Formation Score change(post-op 6,10,13,16,22 weeks, and every 8 weeks thereafter.)
- Detailed callus formation date(at the periods of the first, second, third, and fourth callus formation and endosteal healing.)
- Date of full weight bearing(at time of full weight bearing available)