A Clinical Trial to Investigate the Safety and Efficacy of SurgiFill™, a Bone Grafting Material, in Patients With Femur or Tibia Fracture.
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Cellontech Co., Ltd.
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Bone formation completion date
Overview
Brief Summary
This study is designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with femur or tibia fracture.
Detailed Description
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™.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
SurgiFill™ on femur or tibia fracture
The study group will receive treatment for fracture and SurgiFill™ injection.
Intervention: femur or tibia fracture (Procedure)
SurgiFill™ on femur or tibia fracture
The study group will receive treatment for fracture and SurgiFill™ injection.
Intervention: SurgiFill™ (Device)
Treatment on femur or tibia fracture
The control group will receive only fracture treatment.
Intervention: femur or tibia fracture (Procedure)
Outcomes
Primary Outcomes
Bone formation completion date
Time Frame: 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.
Secondary Outcomes
- 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)